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

Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Providing Follow-Up Care After Heart Attack Helps Reduce Readmissions, Deaths
News | Cath Lab | April 09, 2019
A program designed to help heart attack patients with the transition from hospital to outpatient care can reduce...
TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy
Technology | Cath Lab | April 08, 2019
TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its...
Cook Medical Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments
News | Cath Lab | March 20, 2019
March 20, 2019 — Cook Medical is recalling one lot of its...
DABRA Excimer Laser System Demonstrates Success in Treating PAD
News | Cath Lab | February 27, 2019
Ra Medical Systems Inc. announced a 98 percent success rate in the results from a 52-patient study using the company’s...
Edwards Lifesciences Recalls Swan-Ganz hemodynamic catheters.
Feature | Cath Lab | February 06, 2019
Edwards Lifesciences is recalling its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufa
Scientists Discover New Heart Attack Repair Pathway

A macrophage immune cell, with a dead cell (pink) that has been eaten, and a mitochondrion (green) between the dead cell and the nucleus. The study’s findings indicate that what the macrophage eats is taken up by the mitochondrion, which in turn communicates with the nucleus to activate the macrophage to promote tissue repair. Image courtesy of Northwestern Medicine.

News | Cath Lab | January 30, 2019
Northwestern Medicine scientists have discovered a novel signaling pathway that promotes healing after a heart attack....
Overlay Init