Mitralign to Provide Update on Transcatheter Tricuspid Repair at TCT 2015

Mitralign will present updates on its mitral and tricuspid valve repair platform at the Transcatheter Cardiovascular Therapeutics (TCT) conference Oct 11-15 in San Francisco. As a part of conference updates, the company will also provide details on the SCOUT study utilizing its TriAlignTM Tricuspid Percutaneous Valve Annuloplasty System as part of an Early Feasibility Investigational Device Exemption (IDE) approved by the FDA. The SCOUT study will be a multi-center U.S. study and will commence patient enrollment in Q4 2015.

“We are excited to begin formal clinical investigation in the United States with the TriAlign System to reinforce our position as the most promising percutaneous tricuspid repair solution,” said Rick Geoffrion, chief executive officer of Mitralign.

Mitralign is the only company to provide a direct percutaneous annuloplasty system designed to treat both functional mitral regurgitation (FMR) and tricuspid regurgitation (FTR) with the continued advancement of its core technology. Both the Mitralign and TriAlign Systems feature a customizable therapy solution in concert with an extremely small footprint in the native anatomy. Neither the Mitralign nor the TriAlign Systems are currently approved for sale or distribution.

“The patient population suffering from tricuspid regurgitation continues to need an approved transcatheter repair solution and early experience with the TriAlign System shows encouraging results,” commented Rebecca Hahn, MD, Director of Interventional Echocardiography, Columbia University Medical Center / New York Medical Center / New York Presbyterian Hospital and Principal Investigator for the SCOUT study. “Percutaneous repair for tricuspid regurgitation is the next horizon in valve therapy.”

Updates on Mitralign’s percutaneous solutions will be available in their booth, 2233, and also during a Mitralign sponsored symposium, A Frontline Platform for Transcatheter Mitral and Tricuspid Repair, on October 13 from 1-2 PM in Moscone South, Lower Level, Exhibit Hall Presentation Theater 3. The faculty includes Rebecca T. Hahn, MD, Azeem Latib, MD, Scott Lim, MD, Neil E. Moat, MD and Joachim Schofer, MD.

Additional data on the Mitralign and TriAlign Systems will be presented at the ICI conference from December 13-15 in Tel Aviv, Israel, at the Joint Interventional Meeting (JIM) from February 11-13, 2016 in Milan, Italy and at the American College of Cardiology (ACC) Scientific Sessions from April 2-4, 2016 in Chicago.

About Functional Mitral Regurgitation (FMR)
The mitral valve controls blood flow from the left atrium to the left ventricle of the heart, allowing blood to flow in one direction through the heart and into the body. Functional Mitral Regurgitation (FMR) is the most common valve disease and occurs when the left ventricle of the heart is enlarged, called positive remodeling, and stretches the valve opening. Subsequent to this remodeling, the valve leaflets are not able to come together and close properly, allowing blood to flow, or regurgitate, backwards into the atrium. Consequences can include heart failure or serious rhythm problems called arrhythmias. An estimated four million people in Europe and four million people in the United States have significant mitral valve insufficiency, also known as mitral regurgitation, with an annual incidence of 250,0001. If left untreated, mitral regurgitation overloads the heart and can lead to or accelerate heart failure.

About Tricuspid Regurgitation (TR)
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 U.S. alone, there are an estimated 1.6 million patients suffering from TR2. It is estimated that 50% of patients with mitral regurgitation have moderate to severe tricuspid regurgitation3. TR is currently undertreated by surgery. 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 90% of the time versus replacement (10%)4.

About Mitralign Inc.
Mitralign Inc. is the valve repair company with the only direct transcatheter annuloplasty system designed to treat both functional mitral regurgitation and tricuspid regurgitation. The company is a venture-backed, medical innovation company located near Boston, Massachusetts, USA. For more information, visit www.mitralign.com.

1. Jamieson WR, Edwards FH, Schwartz M, et al. Ann Thorac Surg 1999;67:943-951
2. Stuge O., Liddicoat J., et al. JTCS 2006;132:1258-61
3. Argarwal et al. Circ Cardiovasc Interv 2009;2:565-573
4. RogersJH.Circulation2009:119: 2718-25

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