News | Heart Valve Technology | August 03, 2017

4C Medical's Novel Mitral Regurgitation Repair Therapy Highlighted at Innovation Summit

Mitral Valve regurgitation (MR) showed on an echocardiogram using a Toshiba system

Aug. 3, 2017 — 4C Medical Technologies Inc. minimally invasive therapies for structural heart disease said its transcatheter therapy for mitral regurgitation (MR) was featured in the Innovation Summit at Cardiovascular Innovations (CVI) 2017 held Aug. 2, 2017 in Denver, Colo.

4C Medical is developing an MR therapy that preserves the native mitral valve and left ventricle using a supra-annular, atrial-only fixation technology. The 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.

"The mitral valve anatomy is complex, with many different MR mechanisms. Current TMVR devices have experienced challenges trying to imitate surgical procedures. It is very exciting to see 4C Medical's innovative approach — positioning the implant in the left atrium above the native annulus, with no presence in the left ventricle — to simplify MR treatment and provide a therapeutic option to a broader patient population," said Philippe Généreux, M.D., co-director of the structural heart program at the Gagnon Cardiovascular Institute of Morristown Medical Center in Morristown, N.J., and a practicing interventional cardiologist at Hôpital du Sacré-Coeur de Montréal, Canada.

"We are honored to have been one of the five companies selected to showcase our innovation," said Robert Thatcher, CEO of 4C Medical. "Our team is dedicated to developing better options for patients with MR, and participating in the CVI Innovation Summit further validates the uniqueness of our approach."

4C Medical recently reported that it exceeded its $8 million convertible note offering goal, raising approximately $9 million that will be used to finalize the design of the technology and conduct the early feasibility study.

Mitral regurgitation (MR) is a common heart valve disease affecting nearly 10 percent of Americans aged 75 and older.[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. Approximately 50 percent of patients with severe, symptomatic MR are not referred for surgery mostly due to risks associated with the procedure.2 MR not only develops with age but also affects young patients, resulting in an overall mortality rate of 50 percent at 5 years. With age, the mortality rate increases. Patients above 75 years of age experience a mortality rate of 50 percent at one year. There is a significant potential benefit for minimally invasive solutions to address the unmet clinical need for patients who are not suitable candidates for MR surgery. 

4C Medical is developing minimally invasive therapies for MR and tricuspid regurgitation. 

Read about "4C Medical's Novel Mitral Regurgitation Therapy Highlighted at TVT Innovation Forum."
 

References:

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.

2. Mirabel M, Iung B, Baron G, et al. “What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery?” Eur Heart J. 2007;28(11):1358-65.

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