4C Medical's AltaValve System Commences Pivotal Trial Enrollment

MINNEAPOLIS, Oct. 8, 2024 /PRNewswire/ -- 4C Medical Technologies, Inc. ("4C Medical"), a medical device company dedicated to advancing minimally invasive therapies for structural heart disease, has commenced enrollment in the ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) trial in Europe and United States. ATLAS is a pivotal trial that is designed to assess the safety and efficacy performance of its AltaValve^™ System in treating patients with moderate-to-severe or severe mitral regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair (NCT06465745). The trial is designed with two separate non-randomized cohorts.:

a) Moderate/severe mitral annular calcification (MAC) Cohort, and
b) Primary Cohort that will include patients with no or mild MAC. 

"The AltaValve System is the first atrial fixation transcatheter mitral valve replacement (TMVR) device that is designed to minimize challenges of the sub-valvular TMVRs, especially screen failures associated with the risk of left ventricular outflow tract obstruction, damage to the left ventricle and MAC," said Ron Waksman, M.D., interventional cardiologist at Medstar Washington Hospital Center (Washington, DC) and the Steering Committee Chair for the ATLAS trial. 

"We are excited to have successfully enrolled the first US patients in the ATLAS trial. I am particularly excited as the AltaValve System is designed to offer the broadest applicability for wide range of pathologies," said Paul Sorajja, M.D., interventional cardiologist at Minneapolis Heart Institute (Minneapolis, MN) and Co-Principal Investigator (PI) of the trial. "It is an intuitive and predictable procedure with a repositionable implant that is very much needed for the treatment of patients worldwide."

Dr. Yoshi Kaneko, cardiothoracic surgeon at Barnes-Jewish Hospital (St. Louis, MO), shares Co-PIs responsibilities with Dr. Sorajja in US, while Dr. Vlasis Ninios, an interventional cardiologist at Interbalkan Medical Center (Thessaloniki, Greece), and Dr. Lenard Conradi, cardiothoracic surgeon at University Hospital Cologne (Cologne, Germany), share Co-PIs responsibilities in Europe.

"It takes significant dedication and a lot of teamwork to take an innovative solution to treat MR from ideation to a global pivotal trial. We are very grateful for such strong support from key opinion leaders worldwide who are helping us carry our novel AltaValve System through pivotal trial with a goal of delivering safe and effective treatment solution for patients suffering from MR," said Saravana Kumar, CEO and President at 4C Medical.

About 4C Medical Technologies, Inc.
4C Medical is at the forefront of medical device innovator, focusing on developing transformative technologies for structural heart disease, initially targeting MR treatment and subsequently expanding to tricuspid regurgitation. The AltaValve System represents a paradigm shift in MR treatment with its atrial fixation as compared to sub-valvular TMVR devices that rely on rigid anchoring mechanisms, affecting hemodynamics and being able to treat very limited number of MR patients. The AltaValve System is designed to bypass the complexity and variability of the mitral annulus and left ventricle, preserving critical cardiac structures and native hemodynamics, and providing treatment option for a broad number of MR patients.

For more information about 4C Medical and the AltaValve System, please visit www.4CMed.com.

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SOURCE 4C Medical Technologies, Inc.

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