News | Heart Valve Technology | July 19, 2016

Mitralign Completes First-Phase Enrollment in SCOUT Study of Trialign System

Early feasibility study will evaluate Trialign for transcatheter repair of functional tricuspid regurgitation

Mitralign, Trialign system, tricuspid regurgitation. SCOUT U.S. study, phase 1 enrollment

July 19, 2016 — Mitralign Inc. announced last week it has completed subject enrollment in the SCOUT early feasibility study in the United States.

Initial enrollment consists of 15 subjects, according to Mitralign CEO Rick Geoffrion. The company has also received approval to expand the study and enroll an additional cohort of subjects. According to Geoffrion, it is the first U.S. early feasibility study to complete enrollment using a transcatheter device to treat the tricuspid valve.

“The clinical community is excited about the potential opportunity to provide a breakthrough non-surgical option for patients with tricuspid regurgitation. We know the number of people suffering with tricuspid regurgitation is much bigger than previously reported, and we are in the nascent stages of treating this large, unaddressed population,” commented Rebecca Hahn, M.D., director of interventional echocardiography at NewYork-Presbyterian/Columbia University Medical Center and principal investigator for the SCOUT Study. “The Trialign System leaves behind a very small footprint, so we believe this device has the potential to be a front line solution for patients with functional TR [tricuspid regurgitation].”

Tricuspid regurgitation occurs when the tricuspid valve fails to open and close properly, causing blood to flow backwards into the right atrium. If left untreated, TR can lead to heart enlargement and heart failure. In the United States alone, there are an estimated 1.6 million patients suffering from TR1.

The Trialign System is an investigational device and is limited by federal law to investigational use.

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