CAUTION-Investigational Device. Limited by United States Law to Investigational Use.


CARDIAC DIMENSIONS hires Gretchen Gary as Vice President of Global Therapy Development

Kirkland, WA – March 5, 2020 — Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the hiring of Gretchen Gary as Vice President of Global Therapy Development. Ms. Gary brings more than 17 years of structural heart sales, training and market development experience and will be responsible for implementing the Company’s commercial strategy for the Carillon Mitral Contour System ®.

Ms. Gary joins Cardiac Dimensions from Livanova where she held the position of Senior Director of Global Therapy Development and was responsible for establishing a multi-disciplinary physician advisory board to develop patient management treatment guidelines for a novel transcatheter mitral valve replacement (TMVR) product. Ms. Gary also held executive level positions at CardioKinetix, where she led market development efforts in five countries across three continents, and Direct Flow Medical where she built a field team and training department to support pivotal trial execution. Ms. Gary’s prior experience includes Market Development Manager, Director of Global Sales Training and Director of Sales/European Country Manager at Abbott. In these roles, Ms. Gary was responsible for market development and commercialization of the MitraClip TMVr System in more than ten countries.

“We are extremely excited to have Gretchen join the Cardiac Dimensions team,” commented Rick Wypych, Chief Operating Officer of Cardiac Dimensions. “Her strong track record of commercial success and deep understanding of the structural heart space, our customer’s needs and the competitive landscape is a tremendous asset as we broaden adoption of the Carillon Mitral Contour System and prepare for US commercialization in the not-too-distant future.”

Ms. Gary commented, “Because FMR in heart failure is a devastating disease, the development of minimally invasive products for treatment is of critical importance. I am very excited to be joining Cardiac Dimensions and am eager to leverage my structural heart experience and make a valuable contribution to this first-of-a-kind pivotal trial.” She commented “I believe the Carillon System has the potential to change the lives of many patients by providing relief from their symptoms and slowing the progression of heart failure.”

The hiring of Ms. Gary precedes announcement of findings of a post hoc analysis of pooled prospectively collected data from three studies of the Carillon Mitral Contour System with a focus on 5-year survival rate and the determinants of long-term survival. The data was presented in a late-breaking trials session at the Cardiovascular Research Technologies meeting (CRT 2020) in National Harbor, MD and published in Cardiovascular Revascularization Medicine. The results demonstrated a lower three-year mortality rate compared to published outcomes of COAPT and guideline directed medical therapy (GDMT). Using matched patient populations, all-cause mortality rate of the Carillon was 33.7% for Carillon, 42.8% for MitraClip in COAPT and 55.5% for GDMT. Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance and decrease in regurgitant volume during the first year of follow-up.1

An estimated 26 million people, worldwide, suffer from heart failure2 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 2030.3

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.4,5  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. 6,7,8,9

The Carillon System is CE-marked (0344) and has been implanted in over 1100 patients in the U.S., Europe, Australia, Turkey and the Middle East. The Carillon System is currently being studied in the CARILLON 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:

Rick Wypych

rwypych@cardiacdimensions.com

(425) 605-5910

 

  1. 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.
  2. Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1:4–25.
  3. 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.
  4. 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.
  5. Latib, A. “Coronary Sinus Annuloplasty.” New York, Montefiore Medical Center.
  6. 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
  7. 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.
  8. 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.
  9. 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

 

 

Cardiac Dimensions, Carillon and Carillon Mitral Contour System are registered U.S. trademarks of Cardiac Dimensions Pty Ltd.