Press Releases
Cardiac Dimensions Receives Medical Device Regulation (MDR) Certification For Carillon Mitral Contour System
Press Release
Cardiac Dimensions Receives Medical Device Regulation (MDR) Certification For Carillon Mitral Contour System
KIRKLAND, Wash. – January 26, 2023 – Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatment modalities to address patients suffering from heart failure with functional mitral regurgitation (FMR), today announced that its Carillon Mitral Contour System® has received certification under Regulation (EU) 2017/745 (“MDR”).
The MDR program is intended to ensure high standards of safety and quality of medical devices that are produced in, or supplied to, member countries of the EU. According to the most recent data published by the European Commission last December, fewer than 10% of products holding a certificate under the predecessor program, the Medical Devices Directive (MDD), had received MDR certification.
“I am proud of our team, who committed significant time and resources to ensuring our device and systems achieved the new high standards set by the EU, ahead of many in our industry,” said Cardiac Dimensions CEO Rick Wypych. “The excellent safety profile of the Carillon device coupled with the significant body of high-quality evidence supporting the Carillon® therapy were key factors in achieving MDR certification. This milestone signals to our physician partners and patients that they can be confident in the safety and manufacturing excellence of the Carillon system.”
“The Carillon device has the unique ability to both improve FMR symptoms and remodel the heart. MDR certification of the Carillon Mitral Contour System will ensure continued and uninterrupted access to this evidence-based treatment option for heart failure patients with FMR in Europe,” said Prof. Klaus Witte, Chair of Cardiac Device Therapy, University of Aachen.
About the Carillon Mitral Contour System
Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System, is a groundbreaking, non-surgical, minimally invasive device developed to treat patients with mitral valve insufficiency. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy preserves the integrity of the mitral valve to allow for other FMR treatments should they be needed.
The Carillon Mitral Contour System has obtained the CE Mark and Therapeutic Goods Approval (TGA) and is approved for sale in Europe and Australia. It is considered an investigational device in the U.S. For more information, please visit www.CardiacDimensions.com.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure with functional mitral regurgitation (FMR). Left untreated, FMR contributes to heart failure, a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon system addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery.
Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.
Cardiac Dimensions, Carillon, and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.
Media Contact
Michelle McAdam, Chronic Communications Inc.
michelle@chronic-comm.com, +1 310-902-1274
Join our mailing list for invitations to studies along with company announcements.
Cardiac Dimensions Appoints Angie Swenson as Vice President, Clinical Operations
Press Release
Cardiac Dimensions Appoints Angie Swenson as Vice President, Clinical Operations
KIRKLAND, Wash. – January 26, 2023 – Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the appointment of Angie Swenson as Vice President of Clinical Operations.
Ms. Swenson has spent most of the last 20 years leading clinical trials in the U.S., Europe, Japan and Canada and collaborating on reimbursement strategies for therapies targeting cardiovascular disease developed by leading medtech innovators. Most recently, she served as Vice President, Clinical and Regulatory for HLT, Inc., developer of transcatheter aortic heart valve replacement (TAVR) technology, where for five years she led their early feasibility studies. Prior to that, she was an Associate Director of Clinical Research for C.R. Bard subsidiary Lutonix, overseeing global clinical trials for its drug coated balloons for angioplasty. As Clinical Director for therapeutic hypothermia firm Velomedix, she managed all aspects of a multicenter pilot study of its technology in acute STEMI patients. For St. Jude Medical, she handled overall management of a large multicenter heart valve clinical trial supporting FDA clearance and approvals in Europe, Australia, Canada and Japan, as well as post-market heart valve and renal denervation studies. Earlier in her career, she worked for Beckman Coulter as a Clinical Studies Scientist validating projects for FDA submissions. Her broad experience also includes serving as a medical technologist for Cardiac BioMarkers Trial Lab managing cardiac in vitro diagnostics trials for external sponsors, and as a medical technologist for Hennepin County Medical Center. She holds a Bachelor of Science degree in Medical Technology from Minnesota State University and a certificate in Clinical Trial Management from the University of Chicago Graham School.
“Angie’s rich experience in the successful planning and execution of clinical trials and approvals for medtech therapies addressing important valvular and other cardiovascular diseases is ideally suited to our innovative therapy for mitral valve disease,” said Cardiac Dimensions CEO Rick Wypych. “We look forward to benefitting from her insights and expertise as we focus on enrolling the U.S. pivotal EMPOWER Trial of our Carillon™ Mitral Contour System and exploring reimbursement strategies to support it.”
About the Carillon Mitral Contour System
Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System, is a groundbreaking, non-surgical, minimally invasive device developed to treat patients with mitral valve insufficiency. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy can also be used alongside other heart failure treatments should they be needed.
To date, thousands of patients have been treated with the Carillon system throughout the world. Positive safety and performance data on Carillon therapy encompassing more than 350 patients has been published from four previously completed studies and a real-world registry of the Carillon system. Additionally, the pivotal EMPOWER Trial of the Carillon system is currently enrolling patients in the U.S., as well as in select centers worldwide. The EMPOWER Trial is a randomized, blinded, sham-controlled study of a broad population of patients with heart failure caused by early- through late- stage mitral regurgitation defined as MR grades 1-4. Upon FDA approval, it would be the only medical device solution commercially available as front-line therapy for earlier-stage MR patients with MR grade 1-2 not adequately managed with medications.
The Carillon Mitral Contour System has obtained the CE Mark and Therapeutic Goods Approval (TGA) and is approved for sale in Australia and Europe. It is considered an investigational device in the U.S. For more information, please visit www.CardiacDimensions.com.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, secondary mitral regurgitation contributes to heart failure, a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon system addresses the underlying mechanical problem of secondary mitral regurgitation with a catheter-based alternative to medications and invasive surgery.
Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.
Cardiac Dimensions, Carillon, and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.
Media Contact
Michelle McAdam, Chronic Communications Inc.
michelle@chronic-comm.com, +1 310-902-1274
Join our mailing list for invitations to studies along with company announcements.
Cardiac Dimensions Raises $35 Million In Series D Financing
Press Release
Cardiac Dimensions Raises $35 Million In Series D Financing
Funds Expected to Support Enrollment in U.S. Pivotal EMPOWER Trial and European Commercial Expansion for Carillon Mitral Contour System®
KIRKLAND, Wash. – January 5, 2023 – Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced it has closed a $35 million Series D financing round. The financing was co-led by existing investor Horizon 3 Healthcare and an undisclosed strategic investor, with all other existing investors participating, including Arboretum Ventures, Hostplus, EQT Life Sciences (formerly LSP), Lumira Ventures, and M. H. Carnegie & Co.
The company’s lead product – the Carillon Mitral Contour System® – uses a gentle, minimally-invasive approach designed to restore natural mitral valve function without damaging the mitral valve leaflets. In a short, simple procedure, the Carillon® device is intended to induce favorable remodeling while reducing mitral regurgitation (MR), improve patient quality of life, and extend survival for a broad swath of patients, including those with earlier-stage MR.
Proceeds from the financing will be used to enroll the U.S. EMPOWER pivotal study of the Carillon therapy, which commenced late last summer and includes leading centers such as the Cleveland Clinic, Columbia University Medical Center, and Ronald Reagan UCLA Medical Center. Funds will also support expanded sales of the Carillon device in several European countries where it has full reimbursement.
“Having two high quality co-lead investors, including a new strategic investor, as well as the continued financial support of all existing investors, continues to validate Cardiac Dimensions’ solution for heart failure patients suffering from mitral regurgitation. This funding will enable us to continue providing Carillon therapy to a large population of patients in dire need of treatment,” said Cardiac Dimensions CEO Rick Wypych. “We anticipate accelerating enrollment in our EMPOWER pivotal trial where we can now bring Carillon’s benefits to earlier-stage patients with much lower grades of mitral regurgitation. With strong reimbursement in place in key European markets, we also look forward to expanding adoption in these markets and adding new geographies this year.”
“We have been impressed with Carillon’s ability to improve patients’ lives both in clinical studies and in real-world use, and with the company’s ability to leverage these results to grow adoption and commercial sales,” said Matt McNamara, Chief Investment Officer and Board Director for Horizon 3 Healthcare. “We are enthusiastic about the device’s potential to treat heart failure at a much earlier stage than other device therapies, which could make it a frontline treatment with the potential to change the course of the disease.”
In 2021, Carillon therapy was added to the European Society of Cardiology (ESC) Guidelines covering the Diagnosis and Treatment of Acute and Chronic Heart Failure for the treatment of secondary mitral regurgitation (SMR). The guidelines note that the therapy met its primary endpoint in the blinded, sham-controlled, randomized REDUCE FMR trial, has a shorter learning curve and fewer technical requirements than clipping, and does not preclude other heart failure-related procedures.
Data encompassing 101 patients across Germany from the CINCH European post-market registry were recently presented at the 2022 Transcatheter Therapies (TCT) conference. The data showed that an MR grade of 2+ or less was achieved for 96 percent of patients at 12 months and 100 percent of patients by five years. More than 69 percent of patients had a NYHA class of II+ or less at one year, which improved to 79 percent of patients at five years. Safety data showed no device-related significant adverse events out to one year. At two years, the mortality and heart failure hospitalization rates were also notably better than both standard medical management and published data from other commercial device therapies. Previously published survival data on the Carillon device out to six years show favorable survival when compared to medical management.
About the Carillon Mitral Contour System
Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System, is a groundbreaking, non-surgical, minimally invasive device developed to treat patients with mitral valve insufficiency. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy can also be used alongside other heart failure treatments should they be needed.
To date, thousands of patients have been treated with the Carillon system throughout the world. Positive safety and performance data on Carillon therapy encompassing more than 350 patients has been published from four previously completed studies and a real-world registry of the Carillon system. Additionally, the pivotal EMPOWER Trial is currently enrolling patients in the U.S., as well as in select centers worldwide.
The Carillon Mitral Contour System has obtained the CE Mark and Therapeutic Goods Approval (TGA) and is approved for sale in Australia and Europe. It is considered an investigational device in the U.S. For more information, please visit www.CardiacDimensions.com.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, secondary mitral regurgitation contributes to heart failure, a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon system addresses the underlying mechanical problem of secondary mitral regurgitation with a catheter-based alternative to medications and invasive surgery.
Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.
Cardiac Dimensions, Carillon, and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.
Media Contact
Michelle McAdam, Chronic Communications Inc.
michelle@chronic-comm.com, +1 310-902-1274
Join our mailing list for invitations to studies along with company announcements.
Cardiac Dimensions Included in the New 2021 ESC Guidelines for Heart Failure Management
Press Release
Cardiac Dimensions Included in the New 2021 ESC Guidelines for Heart Failure Management
Guidelines support the Carillon Mitral Contour System® for the treatment of heart failure patients with secondary functional mitral regurgitation
KIRKLAND, WA — Sept. 22, 2021 — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the mention of their Carillon Mitral Contour System in the 2021 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. In addition, the Carillon Mitral Contour System can now be considered under the new Class IIb 2021 Guidelines for the Management of Valvular Heart Disease recommendations on indications for mitral valve intervention in chronic severe secondary mitral regurgitation. Both guidelines were recently published in the European Heart Journal.
The latest guidelines, referring to the Carillon Mitral Contour System, state that other percutaneous mitral valve repair systems, such as indirect annuloplasty, are available for treatment of secondary mitral regurgitation (SMR). The guidelines also state the approach has a shorter learning curve, fewer technical requirements than percutaneous edge-to-edge mitral valve repair and does not preclude different procedures once it is performed. The section in the guidelines continues with reference to Cardiac Dimensions’ REDUCE FMR trial that was blinded, sham-controlled and randomized, and met its primary endpoint of mitral regurgitant volume reduction with reverse left ventricle remodeling at 12 months.
The guidelines go on to reference additional Cardiac Dimensions’ studies that confirm the favorable results of the Carillon Mitral Contour System on left atrium volumes and left ventricle remodeling with trends towards improvement in clinical measures, and a reduction in heart failure hospitalizations. Given the newly introduced option of “other percutaneous therapies” in the valvular disease guidelines and being the only non-TEER device mentioned in the heart failure guidelines, the Carillon Mitral Contour System can now be considered the only other non-TEER Class IIb option in the treatment of SMR.
“I’m very pleased to see the Carillon Mitral Contour System mentioned in the 2021 ESC heart failure guidelines,” commented Professor Dr. Horst Sievert, Director of the Cardiovascular Center in Frankfurt and the Director of Internal Medicine, Cardiology and Vascular Medicine of the Sankt-Katharinen-Hospital. “And even more exciting is to have the allowance for other transcatheter valve therapy in the 2021 ESC valve guidelines with the Carillon device the only other device mentioned for use. With so few options available for my SMR patients, it is great to see additional options added to the guidelines.”
The guidelines are considered an important tool for the evaluation of heart failure patients with valvular heart disease in Europe. They provide relevant information on each disease discussed along with a highly didactic approach to and algorithms for the management of patients. Until recently, the paradigm of treatment for SMR focused on medical management of symptoms, yet promising evidence now points to the role transcatheter device treatment options can play today and in the future.
Percutaneous transcatheter techniques for the improvement of SMR have broadened the spectrum of patients who may benefit from mitral valve intervention. The most recent guidelines propose an updated practical approach to the management of patients with heart failure and SMR based on a multidisciplinary Heart Team approach and have started to broaden the tools allowed to treat patients.
“Being the only device, other than TEER, mentioned in the 2021 ESC guidelines for the treatment of secondary mitral regurgitation is a testament to our excellent clinical data and the overwhelming need for additional treatment options in the space,” said Rick Wypych, Cardiac Dimensions President and Chief Executive Officer. “We’ve already seen, with the unveiling of the guidelines, more hospitals becoming aware of the Carillon Mitral Contour System as an important option in the treatment of their patients.”
An estimated 26 million people, worldwide, suffer from heart failure1 and of those, approximately 49 percent have SMR2. Heart failure is a significant clinical and economic burden with direct and indirect costs expected to grow to $70 billion by 20303.
For a copy of the “2021 European Society of Cardiology Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure,” please visit: https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehab368/6358045
About the Carillon Mitral Contour System
Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System, is a groundbreaking, non-surgical minimally invasive device developed to treat patients with mitral valve insufficiency in a safe and effective manner. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy can also be used alongside other heart failure treatments should they be needed.
To date, over 1,500 patients have been treated with the Carillon System throughout the world. Clinical data from over 250 patients in four previously completed studies of the Carillon System have provided the basis for demonstrating the safety and performance of the Carillon device as well as for the related CE Mark, which allows for commercial sales in Europe. Additionally, the U.S. pivotal study, The EMPOWER Trial, is currently enrolling patients in the U.S. as well as select centers worldwide.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, secondary mitral regurgitation contributes to heart failure—a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of secondary mitral regurgitation with a catheter-based alternative to medications and invasive surgery.
Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.
The Carillon Mitral Contour System is approved for sale in Europe through its CE Mark and is an investigational device in the U.S. For more information, please visit cardiacdimensions.com.
Media Contact
Laurie Masonson
email
(917) 459-6164
Join our mailing list for invitations to studies along with company announcements.
Cardiac Dimensions® Announces Launch of Its Optimized U.S. Pivotal Trial – The EMPOWER Trial
Press Release
Cardiac Dimensions® Announces Launch of Its Optimized U.S. Pivotal Trial – The EMPOWER Trial
International Study to Evaluate Innovative Minimally Invasive Treatment for Heart Failure With Early-Stage Functional Mitral Regurgitation
KIRKLAND, WA — Aug. 20, 2021 — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the launch of the U.S. pivotal study The EMPOWER Trial.
The EMPOWER Trial is evaluating the Carillon Mitral Contour System® for the treatment of heart failure patients with early-stage functional mitral regurgitation (FMR). This blinded, randomized trial will compare the Carillon treatment to a sham-controlled group treated with optimal medical management according to established heart failure guidelines. During development of the trial design, Cardiac Dimensions analyzed an extensive amount of data from more than 250 study patients previously enrolled in over four similar trials. Based on these analyses, the device safety profile, and the company’s recent publications, the trial will focus on this extremely large patient population with limited other therapeutic alternatives.
Consistent with prior trials, Cardiac Dimensions will use third-party monitoring, core lab review and external safety reviews, which will produce the most scientifically rigorous clinical data to date in the investigation of heart failure patients with FMR. The combination of quality data, along with the trial being the only blinded, randomized, sham-controlled study performed in the mitral valve space, will make The EMPOWER Trial a landmark clinical study in the area of heart failure.
“The launch of our U.S. study represents a significant milestone for the company and big step forward to being able to offer the Carillon therapy to a patient population in need,” said Rick Wypych, Cardiac Dimensions President and Chief Executive Officer. “It’s interesting that despite just announcing the trial, we are already seeing overwhelming interest from our sites and the physician community, which is a clear testament to the need for additional device therapies for heart failure patients with early-stage FMR.”
The international trial is expected to randomize 300 patients at up to 75 sites. The study has primary safety and efficacy endpoints at 12 months and will follow the randomized patients out to five years to document long-term safety and clinical status.
“I am very excited to launch The EMPOWER Trial,” said Samir Kapadia, M.D., interventional cardiologist, professor of medicine and chairman of the Department of Cardiovascular Medicine at Cleveland Clinic, and the national principal investigator of The EMPOWER Trial. “This will be the first time where we are able to study early intervention with a device in heart failure. The Carillon device will be used to treat heart failure patients with mild and moderate functional mitral regurgitation. This is an extremely large patient population that is currently not being studied by other novel therapies. It will be phenomenal to study the efficacy of the Carillon device in the EMPOWER trial— a rigorously designed, randomized, double blinded, and sham-controlled multicenter clinical trial.”
About the Carillon Mitral Contour System
Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure (HF) by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System®, is a groundbreaking, non-surgical device developed to treat patients with mitral valve insufficiency in a safe and effective manner. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy can also be used alongside other HF treatments should they be needed.
To date, over 1,500 patients have been treated with the Carillon System throughout the world. Clinical data from over 250 patients in four previously completed studies of the Carillon System have provided the basis for demonstrating the safety and performance of the Carillon device as well as for the related CE Mark, which allows for commercial sales in Europe. Additionally, the U.S. pivotal study, The EMPOWER Trial, is currently enrolling patients worldwide.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address HF and related cardiovascular conditions. Left untreated, FMR contributes to HF—a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.
The Carillon Mitral Contour System is approved for sale in Europe through its CE Mark and is an investigational device in the U.S. For more information, please visit cardiacdimensions.com.
Media Contact
Laurie Masonson
email
(917) 459-6164
Join our mailing list for invitations to studies along with company announcements.
Cardiac Dimensions Announces Two New Meta-Analysis Publications Showing Statistically Significant and Clinically Meaningful Benefits to Heart Failure Patients Suffering from Functional Mitral Regurgitation
Press Release
Cardiac Dimensions Announces Two New Meta-Analysis Publications Showing Statistically Significant and Clinically Meaningful Benefits to Heart Failure Patients Suffering from Functional Mitral Regurgitation
KIRKLAND, WA – April 7, 2021 — Cardiac Dimensions announced a published second individual patient data meta‐analysis demonstrating clinically significant outcomes for the Carillon Mitral Contour System®. This publication, in addition to the several others recently published on the Carillon device, continues the series of excellent results for this transcatheter-based indirect annuloplasty device.
Both of the published meta-analyses were conducted from three prospective, core lab reviewed, CEC/DSMB adjudicated and third-party monitored clinical studies which enrolled a total of 209 heart failure patients with reduced ejection fraction and functional mitral regurgitation (FMR). These data were published in the ESC Heart Failure Journal.
In the previously published, first meta-analysis,1 which was focused on patient echocardiographic data, the authors concluded “This comprehensive meta‐analysis of individual patient data has shown that Carillon device provides statistically significant and clinically meaningful benefits on MR severity, LA and LV volumes, and remodeling and rates of subsequent heart failure hospitalization” at 12 months as compared to baseline measures. Professor Andrew Coats, recent Director of the Monash Warwick Alliance and Academic Vice-President, Monash and Warwick Universities and senior author on the publication said, “The findings of this paper are very compelling, consistent with other published Carillon results and would indicate the Carillon device should be seriously considered in the treatment of this ever-growing patient population.”
The second meta-analysis, based on the same patient population, follows a different path which concentrated more on the clinical outcomes of patients. The results from this publication showed significant improvement in 6-minute walk test (6MWT) distance and Kansas City Cardio-myopathy Questionnaire (KCCQ) score at 1 and 12 months from baseline. In addition, more than 50% of the patients had improvements in KCCQ score of greater than 5 points at 12 months and a greater than one class improvement in New York Heart Association (NYHA) classification out to 12 months. Importantly, these positive results remained similar for the parameters analyzed when reviewing the subset of the MR 1+ and 2+ population as compared to the MR 3+ or 4+ population.2
“Heart failure patients often suffer from reduced quality-of-life and compromised physical function, which is why improving their quality-of-life end points should be the primary consideration,” commented Professor of Cardiology Dr. Stefan Anker, Charité University, and an author on the second meta-analysis. “Our patients don’t care if they have regurgitant volume when they come to the hospital. Their focus is around symptoms, quality-of-life, hospitalizations and, as the ultimate goal, long-term survival.”
These new meta-analyses add to the wide range of recently published materials on the Carillon device. These have included rigorous clinical outcome analysis of the landmark REDUCE FMR Trial3 (the first-ever randomized, blinded, sham-controlled study in the transcatheter mitral valve space) results which highlighted a substantially higher number of patients achieved minimum clinically important differences at 12 months as compared to the sham procedure in 6MWT, KCCQ, NYHA class and reduced heart failure hospitalization.4 Notably, recent publications have also included data on long-term patient survival including one which reported 56% survival through 5 years.5
Dr. Janusz Lipiecki, an interventional cardiologist at Pôle Santé République, in Clermont-Ferrand, France, and lead author on the long-term prognosis publication said, “Given medical management of these heart failure patients results in a survival rate of 45% at three years, the 67.9% rate of survival for patients receiving the Carillon device at three years is compelling while the 56% survival rate at five years is simply impressive.”
“These publications, as well as all our others, represent our dedication to high quality clinical data and our continued efforts to make the Carillon device the primary device in the treatment of heart failure patients,” said Rick Wypych, President and CEO of Cardiac Dimensions. “We continually demonstrate a strong positive relationship between the Carillon device and improving the quality-of-life metrics our patients care about. This data shows we are breaking new ground and are excited to advance our unique FMR treatment.”
About the Carillon Mitral Contour System®
The Carillon System offers a simple right heart approach to transcatheter mitral valve repair designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart’s venous anatomy to cinch the mitral apparatus, without compromising the valve or future treatment options. The Carillon System is designed to treat the primary cause of functional mitral regurgitation in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and favorable left ventricular remodeling in a randomized sham-controlled clinical trial of percutaneous valve therapy. The Carillon System is CE-marked (0344) and has been used by physicians in the U.S., E.U., Australia, Turkey and the Middle East. The Carillon System is currently being studied in The CARILLON Trial U.S. pivotal study and limited to investigational use in the United States.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatments to address heart failure and related cardiovascular conditions. Privately held, the company’s lead investors include Aperture Venture Partners, Arboretum Ventures, HostPlus, Life Sciences Partners, Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in Kirkland, Washington and has operations in the United States, Australia, and Germany. For more information, visit cardiacdimensions.com.
Media Contact
Laurie Masonson
email
(917) 459-6164
- Giallauria F, et al., Individual patient data meta‐analysis of the effects of the CARILLON® mitral contour system. ESC Heart Failure.
- Khan MS, et al., Effect of Carillon Mitral Contour System on patient‐reported outcomes in functional mitral regurgitation: an individual participant data meta‐analysis. ESC Heart Failure.
- Witte K, et al., A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation: The REDUCE FMR Trial. JACC Heart Fail.
- Khan MS, et al., Functional outcomes with Carillon device over 1 year in patients with functional mitral regurgitation of Grades 2+ to 4+. ESC Heart Failure.
- Lipiecki J, et al., Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device. Cardiovasc Revasc Med.
Join our mailing list for invitations to studies along with company announcements.
Cardiac Dimensions Welcomes Robert White to its Board of Directors
Press Release
Cardiac Dimensions Welcomes Robert White to its Board of Directors
KIRKLAND, WA – April 6, 2021 — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure, today announced the election of Robert White as an independent director to its Board of Directors. Mr. White is a veteran medical technology executive, innovator and strategist with nearly 30 years of experience leading early-stage companies and Fortune 500 business units within the medical technology sector.
“We are thrilled to welcome Bob to our Board. Bob is a medical device veteran whose experience and insights will be invaluable to the company as we continue with the rapid sales expansion of the Carillon Mitral Contour System and enrollment in our approved U.S. pivotal study,” said Rick Wypych, President and Chief Executive Officer of Cardiac Dimensions.
“It’s exciting to join a leader in the field whose innovative device is addressing the large unmet needs of patients suffering from heart failure,” Mr. White commented. “With the extensive clinical data and commercial experience of Cardiac Dimensions, I’m very excited about what the future holds for the company and the benefits the technology can bring to patients.”
Over the past three decades, Mr. White has served in a number of leadership positions including President and Chief Executive Officer of Entellus Medical, Inc. In 2018, he was recognized as a finalist in the Ernst & Young Entrepreneur of the Year and the YPO Global Innovation Award. Mr. White was also President and Chief Executive Officer of TYRX, Inc. which specialized in commercializing innovative, implantable combination drug and device products focused on infection control. Prior to joining TYRX, he held several executive positions with Medtronic including serving as President of Physio Control, Vice President of Commercial Operations of the Cardiac Rhythm Disease Management business, and President of Kyphon. Earlier in his career, Mr. White held leadership positions in business development, international sales and marketing, operations, and general management with Instromedix/Life Watch, Eli Lilly, IVAC/Alaris Medical, and General Electric. Mr. White is currently an Operating Partner at EW Healthcare. He holds a B.S. in Aerospace Engineering from the University of Missouri-Rolla and an M.B.A. from Cornell University.
About the Carillon Mitral Contour System®
The Carillon System offers a simple right heart approach to transcatheter mitral valve repair designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart’s venous anatomy to cinch the mitral apparatus, without compromising the valve or future treatment options. The Carillon System is designed to treat the primary cause of functional mitral regurgitation in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and favorable left ventricular remodeling in a randomized sham-controlled clinical trial of percutaneous valve therapy. The Carillon System is CE-marked (0344) and has been used by physicians in the U.S., E.U., Australia, Turkey and the Middle East. The Carillon System is currently being studied in The CARILLON Trial U.S. pivotal study and limited to investigational use in the United States.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatments to address heart failure and related cardiovascular conditions. Privately held, the company’s lead investors include Aperture Venture Partners, Arboretum Ventures, HostPlus, Life Sciences Partners, Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in Kirkland, Washington and has operations in the United States, Australia and Germany. For more information, visit cardiacdimensions.com.
Media Contact
Laurie Masonson
email
(917) 459-6164
Join our mailing list for invitations to studies along with company announcements.
Cardiac Dimensions Announces $17.5 Million Series C Financing to Accelerate Sales Expansion of the Carillon Mitral Contour System
Press Release
Cardiac Dimensions Announces $17.5 Million Series C Financing to Accelerate Sales Expansion of the Carillon Mitral Contour System®
Funds to be Used for Commercial Expansion in Europe and Australia
KIRKLAND, WA – September 29, 2020 — Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure, today announced the company has closed a $17.5 million Series C financing. All existing shareholders participated in the round including Aperture Venture Partners, Arboretum Ventures, Hostplus, Life Sciences Partners, Lumira Ventures, and M. H. Carnegie & Co.
The financing will be used to accelerate commercial sales of Cardiac Dimensions’ Carillon Mitral Contour System® in Europe and allow for expansion into other geographies such as Australia. Earlier this month, Australia’s Therapeutic Goods Administration approved the Carillon System for commercial use in FMR patients with mild to severe mitral regurgitation.
“The Carillon System is a transformative product which has shown great success in helping an extremely large patient population with very few options,” said Rick Wypych, Chief Executive Officer and President of Cardiac Dimensions. “The new round of financing will allow for continued growth of sales in Europe and provide capital for our expansion efforts into other geographies–such as Australia. We thank our investors for their continued support as our business shows excellent results despite the challenging environment.”
An estimated 26 million people, worldwide, suffer from heart failure1 and of those, approximately 70 percent have functional mitral regurgitation. FMR is due to the mitral valve not closing tightly, resulting in blood flowing or leaking backwards through the mitral valve. This further decreases the amount of oxygenated blood that is pumped out to the body, increases the symptoms associated with heart failure, and decreases the quality of life of those who have been diagnosed.
“We’re excited to support the expansion of sales of the Carillon System,” said Trevor Moody of M. H. Carnegie & Co. “Cardiac Dimensions’ innovative efforts and dedication to expanding access to the Carillon System will soon allow people worldwide to benefit from this therapeutic innovation.”
About the Carillon Mitral Contour System
The Carillon System offers a simple right heart approach to transcatheter mitral valve repair designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart’s venous anatomy to cinch the mitral apparatus without compromising the valve or future treatment options.2,3 The Carillon System is designed to treat the primary cause of functional mitral regurgitation in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and favorable left ventricular remodeling in a randomized sham-controlled clinical trial of percutaneous valve therapy.4,5.6 The Carillon System is CE-marked (0344) and has been implanted in over 1,200 patients in the U.S., Europe, Australia, Turkey and the Middle East. The Carillon System is currently being studied in The CARILLON Trial pivotal trial and limited to investigational use in the United States.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatments to address heart failure and related cardiovascular conditions. Privately held, the company’s lead investors include Aperture Venture Partners, Arboretum Ventures, HostPlus, Life Sciences Partners, Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in Kirkland, Washington and has operations in the United States, Australia and Germany. For more information, visit cardiacdimensions.com.
Media Contact
Laurie Masonson
laurie@greymattermarketing.com
(917) 459-6164
- Lipiecki J, Kaye DM, Witte KK, et al. Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device. Cardiovascular Revascularization Medicine. Advance online publication. doi:10.1016/j.carrev.2020.02.012.
- Hoppe UC, Brandt MC, Degen H, et al. Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy. Catheter Cardiovasc Interv. 2009;74(3):506-11.
- Latib, A. “Coronary Sinus Annuloplasty.” New York, Montefiore Medical Center.
- Lipiecki J, Siminiak T, Sievert H, et al. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. BMJ Open Heart. 2016; 3
- Siminiak T, et. al. Treatment of functional mitral regurgitation by percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail. 2012;14:931-38.
- Sievert, H. 2018. REDUCE-FMR: A Sham-controlled Randomized Trial of Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with Functional Mitral Regurgitation. Presented at TCT 2018, San Diego, CA.
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Cardiac Dimensions Announces Australian Therapeutic Goods Administration’s Approval of the Carillon System for the Treatment of Functional Mitral Regurgitation
Press Release
Cardiac Dimensions Announces Australian Therapeutic Goods Administration’s Approval of the Carillon System for the Treatment of Functional Mitral Regurgitation
KIRKLAND, WA – September 2, 2020 — Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure, today announced the Therapeutic Goods Administration (TGA) has approved its Carillon Mitral Contour System®. The Carillon System is a right heart transcatheter mitral valve repair (TMVr) device designed to treat the primary cause of FMR in patients with mitral regurgitation grades 2+, 3+ and 4+.
“We would like to thank the Therapeutic Goods Administration for their partnership in the review and approval of the Carillon System in Australia,” said Rick Wypych, Chief Executive Officer and President of Cardiac Dimensions. “This is a significant milestone as Australian patients with heart failure can now be treated earlier in their disease state with a minimally invasive treatment for mitral regurgitation.”
An estimated 26 million people, worldwide, suffer from heart failure1 and of those, approximately 70 percent have FMR. Heart failure is a significant clinical and economic burden with direct and indirect costs expected to grow to $70 billion by 2030.2
“The availability of the Carillon System is an extremely exciting advancement for the medical community as this technology has the potential to help millions of patients suffering from heart failure and FMR,” commented David Kaye, MD, Director of Cardiology at The Alfred Hospital, Melbourne, Australia. “The Carillon System provides a new, non-surgical method to correct a fundamental problem with the mitral valve in patients with heart failure. This approach has been shown to reduce mitral regurgitation and to favorably impact the left ventricle (LV). This is significant because a reduction in LV enlargement in heart failure is known to be associated with positive patient outcomes.”
The Carillon System is placed using a non-surgical, minimally invasive (catheter-based) technique in a vein on the outside of the heart that is adjacent to the mitral valve. This procedure is designed to reshape the mitral valve, reduce valve leakage, and thus reduce mitral regurgitation and induce favorable remodeling.
The TGA’s approval was based on the combined efficacy and safety results from several Cardiac Dimensions’ studies including the most recent REDUCE FMR study. Treatment with the Carillon Mitral Contour System in these studies consistently demonstrated a significant decrease in regurgitant volume and left ventricular volumes. These changes were associated with reduced heart failure symptoms and improved quality of life.
“M.H. Carnegie & Co. and Hostplus, a large investor in our medical device initiative, recognized early on the importance of the Carillon System to patients and have been a significant supporter of the therapy and the company during their journey,” said Mark Carnegie of M.H. Carnegie & Co. “We’re excited now that the company has approval in Australia and look forward to the benefits it brings this underserved patient population.”
About the Carillon Mitral Contour System®
The Carillon System offers a simple right heart approach to transcatheter mitral valve repair (TMVr) designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart’s venous anatomy to cinch the mitral apparatus, without compromising the valve or future treatment options.3,4 The Carillon System is designed to treat the primary cause of functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and favorable left ventricular remodeling in a randomized sham-controlled clinical trial of percutaneous valve therapy.5,6,7 The Carillon System is CE-marked (0344) and has been implanted in over 1,200 patients in the U.S., Europe, Australia, Turkey and the Middle East. The Carillon System is currently being studied in The CARILLON Trial pivotal trial and limited to investigational use in the United States.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatments to address heart failure and related cardiovascular conditions. Privately held, the company’s lead investors include Aperture Venture Partners, Arboretum Ventures, HostPlus, Life Sciences Partners, Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in Kirkland, Washington and has operations in the United States, Australia and Germany. For more information, visit cardiacdimensions.com.
- Lipiecki J, Kaye DM, Witte KK, et al. Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device. Cardiovascular Revascularization Medicine. Advance online publication. doi:10.1016/j.carrev.2020.02.012.
- Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1:4–25.
- Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the Impact of Heart Failure in the United States. Circ Heart Fail. 2013;6(3):606-19.
- Hoppe UC, Brandt MC, Degen H, et al. Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy. Catheter Cardiovasc Interv. 2009;74(3):506-11.
- Latib, A. “Coronary Sinus Annuloplasty.” New York, Montefiore Medical Center.
- Lipiecki J, Siminiak T, Sievert H, et al. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. BMJ Open Heart. 2016; 3
- Siminiak T, et. al. Treatment of functional mitral regurgitation by percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail. 2012;14:931-38.
- Sievert, H. 2018. REDUCE-FMR: A Sham-controlled Randomized Trial of Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with Functional Mitral Regurgitation. Presented at TCT 2018, San Diego, CA.
- Witte K, et al, A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation: The REDUCE FMR Trial. J Am Coll Cardiol, HF I, DOI: 10.1016/j,jchf.2019.06.011