A first U.S. subject has been enrolled in heart valve developer Mitralign’s SCOUT Study using the Trialign™ (Percutaneous Tricuspid Valve Annuloplasty) System.
Background
Functional Tricuspid Regurgitation (FTR) 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 weaken the heart leading to heart enlargement and ultimately progressing to heart failure. It is estimated that 50% of patients with mitral regurgitation have moderate to severe tricuspid regurgitation. However, in the U.S., surgeons treat only 5,500 patients per year, most of them in conjunction with left heart surgeries. When treating the valves, surgeons choose repair rather than replace the valve 90% of the time.
Valve repair company Mitralign Inc., has developed a transcatheter direct annuloplasty system designed to treat both functional mitral regurgitation and functional tricuspid regurgitation, which is not yet available commercially, hence the existence of the SCOUT trial. SCOUT is a U.S. based early feasibility Investigational Device Exemption study using the Trialign system in subjects with symptomatic chronic FTR. It will assess the early safety and feasibility of the device for the treatment of tricuspid regurgitation in subjects with a minimum of moderate tricuspid regurgitation and in whom left‐sided valve surgery is not planned.
The first procedure was performed by Dr. Rebecca Hahn, Director of Interventional Echocardiography, Principal Investigator for the SCOUT study and Dr. Susheel Kodali, Interventional Cardiologist and Director, Structural Heart and Valve Program at NewYork-Presbyterian/Columbia University Medical Center.
Investigator comments
“We are extremely excited to be pioneering a novel solution in percutaneous repair for the tricuspid valve,” commented Dr. Hahn. “Given the reports that operative mortality for tricuspid valve replacement (TVR) surgery can top 30%, coupled with the lack of treatment options, this system represents a very welcome advancement.”
Company comments
“An estimated 1.6 million patients suffer from tricuspid regurgitation in the U.S., yet little progress has been made developing tricuspid specific therapies,” stated Rick Geoffrion, chief executive officer of Mitralign. “We are proud to be at the forefront of transcatheter repair for tricuspid regurgitation.”
Source: Business Wire
published: December 7, 2015 in: Cardio, Clinical Studies/Trials