4C Medical Begins Enrollment in ATLAS Heart Valve Trial

4C Medical Technologies has begun enrollment in its ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) trial in Europe in the U.S.
 
The ATLAS pivotal trial will evaluate the company’s AltaValve system to treat patients with moderate-to-severe mitral regurgitation (MR) who aren’t suitable for surgery or transcatheter edge-to-edge (TEER) repair. The trial is designed with two randomized cohorts:

• Moderate/severe mitral annular calcification (MAC) cohort
• Primary cohort that will include patients with no or mild MAC

 
4C Medical’s TMVR differentiates from other MR replacement devices with an atrial-only fixation. It preserves the native mitral valve and left ventricle, minimizing challenges associated with traditional TMVR replacement technologies. These rely on placement and fixation in the native mitral annulus and left ventricle.
 
AltaValve earned two U.S. Food and Drug Administration (FDA) breakthrough device designations in May.
 
“It takes significant dedication and a lot of teamwork to take an innovative solution to treat MR from ideation to a global pivotal trial,” said Saravana Kumar, president and CEO of 4C Medical. “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,”.
 
“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 risk of the risk of left ventricular outflow tract obstruction, damage to the left ventricle and MAC,” said Ron Waksman, MD, interventional cardiologist at Medstar Washington Hospital Center (Washington, DC) and the Steering Committee Chair for the ATLAS trial.