BROOKLYN PARK, Minn., Aug. 3, 2017 /PRNewswire/ -- 4C Medical Technologies, Inc. (4C Medical), a developer of minimally invasive therapies for structural heart disease, today announced that its medical device therapy for mitral regurgitation (MR) was featured in the Innovation Summit at Cardiovascular Innovations (CVI) 2017 held August 2, 2017 in Denver, CO.
4C Medical 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.
"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, MD, Co-Director of the Structural Heart Program at the Gagnon Cardiovascular Institute of Morristown Medical Center (Morristown, NJ) and a practicing Interventional Cardiologist at Hôpital du Sacré-Coeur de Montréal (Montreal, 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.
About Mitral Regurgitation
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. 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 1 year. Hence, 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.
About 4C Medical Technologies, Inc.
4C Medical is a medical device company developing minimally invasive therapies for structural heart disease, focusing initially on mitral regurgitation (MR) therapy and subsequently on tricuspid regurgitation therapy. The company's implant is the first MR therapy with supra-annular positioning and atrial-only fixation. It preserves the native mitral valve and left ventricle, eliminating known issues associated with transcatheter mitral valve replacement technologies which rely on placement and fixation in the native mitral annulus and left ventricle.
- 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.
- 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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SOURCE 4C Medical Technologies, Inc.