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

Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...
News | Cath Lab | December 18, 2019
December 18, 2019 — Cook Medical initiated a recall of its CrossCath Support Catheters in November, which the U.S.
Gallery | Cath Lab | October 31, 2019 | Dave Fornell, Editor
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t
OmniVision Announces Guinness World Record for Smallest Image Sensor

OmniVision's OVM6948 CameraCubeChip, a fully packaged, wafer-level camera module measuring 0.65mm x 0.65mm x 1.158mm, built on OmniVision's OV6948, winner of the Guinness World Record for “The Smallest Image Sensor Commercially Available.”

News | Cath Lab | October 22, 2019
October 22, 2019 — OmniVision Technologies Inc.
People watch the presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., live in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long term surgical outcomes. #TCT2019

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes. 

Feature | Cath Lab | October 03, 2019
October 3, 2019 – Five-year data from the EXCEL Trial showed patients with left main coronary disease treated with pe
Overlay Init