News | Heart Valve Technology | June 15, 2017

4C Medical's Novel Mitral Regurgitation Therapy Highlighted at TVT Innovation Forum

Presentation Featured the Company's Supra-Annular Implant, the First Transcatheter Mitral Regurgitation Therapy with Atrial-Only Fixation

Mitral Valve regurgitation showed on an echocardiogram, cardiac ultrasound

Mitral valve regurgitation showed on an echocardiogram. Image from Toshiba.

June 15, 2017 — 4C Medical Technologies Inc., a developer of minimally invasive therapies for structural heart disease, had its medical device therapy for mitral regurgitation (MR) featured in the Transcatheter Valve Therapies (TVT) Innovation Forum in Chicago. The company is developing the first MR therapy that preserves the native mitral valve and left ventricle using a supra-annular, atrial-only fixation technology. The novel design eliminates known issues of current transcatheter mitral valve replacement (TMVR) technologies which rely on placement and fixation in the native mitral annulus and left ventricle.

"4C Medical's mitral valve is an innovative and simple solution for a very common problem, and its unique mechanism will allow treatment of many patients not suitable for current TMVR devices," said Philippe Généreux, M.D. "30-day pre-clinical results are promising and demonstrate concept feasibility and safety, with no hemodynamic compromise, no thrombus, and mild-to-no MR as confirmed by echocardiography."

Généreux presented "4C Medical Valve: A Novel Transcatheter MR Treatment Technology" and facilitated subsequent roundtable discussions with audience Q&A. He is co-director of the structural heart program at the Gagnon Cardiovascular Institute of Morristown Medical Center (Morristown, N.J.) and a practicing Interventional Cardiologist at Hôpital du Sacré-Coeur de Montréal (Montreal, Canada).

"The main challenges encountered by current TMVR devices are related to the complexity of the mitral valve anatomy and the multitude of MR mechanisms," Généreux explained. "With its supra-annular position in the left atrium, the 4C Medical device preserves the native valve apparatus and avoids all issues related to the complexity and dynamism of the mitral annulus, making the device suitable for patients independent of their MR mechanism. This unique approach promotes healthy left ventricular remodeling and healing, and eliminates the complications that are associated with current TMVR devices, such as left ventricular outflow tract obstruction, device embolization and early device fatigue failure."

Mitral regurgitation (MR) is a common heart valve disease affecting nearly 10 percent of Americans aged ≥75 years.1 MR occurs when the mitral valve leaflets do not close properly and allow blood in the left ventricle to leak back into the left atrium. It is a progressive disease and if left untreated, MR can lead to atrial fibrillation, pulmonary hypertension, heart failure and death.

4C Medical Technologies is developing minimally invasive therapies for MR therapy and tricuspid regurgitation therapy. The company's supra-annular implant is the first MR therapy with atrial-only fixation, thereby eliminating known issues associated with transcatheter MR replacement technologies which rely on placement and fixation in the native mitral annulus and left ventricle.

Reference:

1. Nkomo VT, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368:1005-11. doi: 10.1016/S0140-6736(06)69208-8.

Related Content

Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Sponsored Content | Videos | Cath Lab | September 19, 2018
William O’Neill, M.D., outlines his recent clinical publication of AMICS patients from the Impella Quality (IQ) datab
Videos | Cath Lab | September 14, 2018
A discussion with Nicolas Bevins, Ph.D., vice chair, physics and research, and Jessica Harrington, RCIS.
A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. DAIC staff photo by Dave Fornell

A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. (right) who is proctoring a fellow in treating CTOs.

Feature | Cath Lab | September 13, 2018 | Artur Kim, Kamran Zamanian
Coronary artery disease (CAD) is a multifaceted disease that demands various approaches in terms of diagnosis and tre
Videos | Cath Lab | August 13, 2018
Jeffrey Schussler, M.D., FACC, FSCAI, FSCCT, FACP, interventional cardiologist at Baylor Scott White Heart and Vascul
Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Overlay Init