Andrew Richards
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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.
CRF TCT 2022 Poster
TCT 2022 Poster
Goldberg S et al.
2022
Baseline data
Survival
Interim Results of the CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation (FMR) With the Carillon Mitral Contour System
TCT 2022 Poster
Goldberg S et al.
2022
Prospective trials of the Carillon Mitral Contour System have shown effective hemodynamic and clinical improvement in patients with heart failure and functional mitral regurgitation (FMR) including beneficial left ventricular and left atrial remodeling.
The CINCH registry is a multi-center, real-world study of patients treated with the Carillon device as standard of care. It is intended to enroll up to 250 patients in up to 40 centers in Germany.
The poster presented shows an interim analysis of 101 patients with up to 5 years follow-up data, including mortality, device related safety, change in NYHA class and rate of heart failure hospitalizations.
Treating Symptoms and Reversing Remodelling: Clinical and Echocardiographic 1-Year Outcomes with Percutaneous Mitral Valve Annuloplasty for Mild to Moderate Regurgitation
EJHF
Witte K et al.
2021
Obwohl bekannt ist, dass jeder Grad einer sekundären Mitralinsuffizienz (SMI) die Symptome der Herzinsuffizienz und die Sterblichkeit weiter verschlimmert, fehlt ein überzeugendes Behandlungsschema für Patienten mit einer leichten und mittelschweren SMI. Die jüngste Veröffentlichung über das Carillon-System im European Journal of Heart Failure beleuchtete insbesondere diesen Punkt.
Ziel der Untersuchung der Autoren war es, die Auswirkungen der perkutanen Mitralanuloplastie auf die Symptome, die 6-Minuten-Gehstrecke sowie die Struktur und Funktion des linken Ventrikels (LV) von Patienten mit leichter oder mittelschwerer SMR bei Herzinsuffizienz mit reduzierter Ejektionsfraktion zu ermitteln. Sie untersuchten retrospektiv insgesamt 68 Patienten aus allen Carillon-Studien über den Verlauf von 12 Monaten, die eine leichte und mittlere SMI aufwiesen. Die Ergebnisse waren sehr ermutigend:
- Die mittlere 6-Minuten-Gehteststrecke nahm um 34 m zu (95% CI 12 bis 57; P < 0,01)
- Der mittlere KCCQ-Score verbesserte sich gegenüber dem Ausgangswert um 10 Punkte [95 % Konfidenzintervall (CI) 3 bis 17; P < 0,01].
- Der SMI-Grad verbesserte sich bei 25 % der Patienten und wurde bei 58 % der Patienten beibehalten, wobei sich das mittlere Regurgitationsvolumen um -7 ml (95 % CI -11 bis -3; P < 0,001), die Vena contracta um -0,11 cm (95 % CI -0,20 bis -0,02; P < 0,05) und die effektive Regurgitations-Öffnungsfläche um -0,03 cm2 (95 % CI -0,06 bis -0,01; P < 0,05) veränderte.
- Bei der überwiegenden Mehrheit der Patienten wurde der New York Heart Association Status (NYHA) beibehalten (48 %) oder verbessert (46 %).
- Die Überlebensrate nach einem Jahr lag bei 89 %, und 73 % der Patienten waren frei von Krankenhausaufenthalten aufgrund der Herzschwäche.
Die Autoren schlussfolgern: “Bei Patienten mit symptomatischer HF und leichter oder mäßiger SMR unter leitliniengerechter medikamentöser Therapie war die perkutane Mitralanuloplastie [d. h. die Carillon-Therapie] mit Verbesserungen der Symptome, der SMI, einer Stabilisierung der LV-Struktur und -Funktion sowie hohen Überlebensraten verbunden.”
Indirect Mitral Annuloplasty Using the Carillon Device
Frontiers
Krishnaswamy et al.
2020
“Patienten mit funktioneller oder sekundärer Mitralinsuffizienz (FMI, SMI) leiden häufig unter erheblichen Symptomen, die zu einer Verschlechterung der Funktionsfähigkeit sowie zu Krankenhausaufenthalten und sogar zum Tod führen. Die herkömmliche Mitralanuloplastie ist eine wichtige Behandlungsoption für Patienten mit FMR, aber das chirurgische Risiko und die Dauerhaftigkeit stellen wichtige Einschränkungen dar. Perkutane Strategien sind daher eine willkommene Alternative. Das Carillon Device nutzt die Beziehung zwischen dem Koronarsinus und dem Mitralanulus, um eine “indirekte” Anuloplastie durchzuführen. Frühe Versuchsserien und neuere randomisierte Studien deuten auf echokardiografische und klinische Vorteile bei einer relativ unkomplizierten Implantationstechnik und einer geringen Rate signifikanter Komplikationen hin.”
Complex transcatheter aortic valve replacement in aortic regurgitation and transcatheter mitral annuloplasty in severe dextrocardia
Eur J Cardiothorac Surg
Rudzinski et al.
2021
Diese Publikation dokumentiert den Fall einer 70-jährigen Frau mit symptomatischer schwerer nativer Aortenregurgitation, erworbener Dextrokardie, mittelschwerer bis schwerer sekundärer Mitralregurgitation und einem Operationsrisiko, das einen chirurgischen Eingriff verbietet. Sechs Monate nach der Behandlung mit einem Aortenklappenersatz blieb die Patientin aufgrund einer mittelschweren bis schweren sekundären Mitralinsuffizienz symptomatisch. Sie wurde mit der Carillon-Therapie behandelt, die zu einer signifikanten Verringerung der Mitralregurgitation und zu einem unauffälligen weiteren Verlauf führte.
Dieser Fall veranschaulicht die Flexibilität des Carillon-Implantats, das erfolgreich neben anderen Therapien eingesetzt werden kann. Er verdeutlicht ebenfalls die kurze Lernkurve der Carillon-Therapie, da der Eingriff von einem Herzchirurgen und nicht von einem interventionellen Kardiologen durchgeführt wurde.
Indirect Mitral Annuloplasty Using the Carillon Device
Frontiers
Krishnaswamy et al.
2020
“Patients with functional, or secondary, mitral regurgitation (FMR, SMR) often face significant symptoms that lead to functional decline as well as hospitalization and even death. Traditional mitral annuloplasty is an important treatment option for patients with FMR, but surgical risk and durability are important limitations. Percutaneous strategies are therefore a welcome alternative. The Carillon device utilizes the relationship of the coronary sinus and the mitral annulus to affect an “indirect” annuloplasty. Early series’ and recent randomized trials suggest echocardiographic and clinical benefit with a relatively straight-forward implantation technique and low rate of significant complications.”
