Mitralign Inc. 12.15.15
Mitralign Inc. has enrolled its first patient in a study of the company’s Trialign (Percutaneous Tricuspid Valve Annuloplasty) System. The procedure was performed by Dr. Rebecca Hahn, director of Interventional Echocardiography and 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.
“We are extremely excited to be pioneering a novel solution in percutaneous repair for the tricuspid valve,” said Dr. Hahn. “Given the reports that operative mortality for tricuspid valve replacement (TVR) surgery can top 30 percent1, coupled with the lack of treatment options, this system represents a very welcome advancement.”
SCOUT is a U.S- based early feasibility investigational device exemption study using the Trialign system in subjects with symptomatic chronic functional tricuspid regurgitation (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.
“An estimated 1.6 million patients suffer from tricuspid regurgitation in the U.S.2, yet little progress has been made developing tricuspid specific therapies,” stated Rick Geoffrion, CEO of Mitralign. “We are proud to be at the forefront of transcatheter repair for tricuspid regurgitation.”
Functional Tricuspid Regurgitation (FTR), sometimes called tricuspid insufficiency, occurs when the tricuspid valve fails to open and close properly, causing blood to flow backwards into the right atrium. It is estimated that 50 percent of patients with mitral regurgitation have moderate to severe tricuspid regurgitation3. However, in the United States,
surgeons treat only 5,500 patients per year, most of them in conjunction with left heart surgeries4. When treating the valves, surgeons choose repair 90 percent of the time versus replacement 10 percent4. If left untreated, transcuspid regurgitation can weaken the heart leading to heart enlargement and ultimately progressing to heart failure.
Mitralign Inc. is the valve repair company with a transcatheter direct annuloplasty system designed to treat both functional mitral regurgitation and functional tricuspid regurgitation.
The system is not available for commercial use. The company is a venture-backed, medical innovation firm located near Boston, Mass.
References:
1. Levinger DB et al, J Heart Valve Dis. 2014;23:209
2. Stuge O., Liddicoat J., et al. JTCS 2006;132:1258-61
3. Argarwal et al. Circ Cardiovas Inverv 2009;2:565
4. Rogers JH. Circulation 2009:119: 2718-25
References:
1. Levinger DB et al, J Heart Valve Dis. 2014;23:209
2. Stuge O., Liddicoat J., et al. JTCS 2006;132:1258-61
3. Argarwal et al. Circ Cardiovas Inverv 2009;2:565
4. Rogers JH. Circulation 2009:119: 2718-25