News | Heart Valve Technology | October 28, 2016

Trialign SCOUT I Study for Tricuspid Repair to Be Presented at TCT 2016

SCOUT I is the first clinical study to report 30-day subject data examining transcatheter tricuspid repair in the United States

Mitralign, Trialign tricuspid repair system, SCOUT I study, 30-day data, TCT 2016

October 28, 2016 — Mitralign will present data on its Trialign Tricuspid Repair system at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) conference, which will be held in Washington, D.C. Oct. 29-Nov. 2. The company will be presenting 30-day data from SCOUT I, a U.S. multi-center, early feasibility study (EFS).

The data will be presented by Rebecca Hahn, M.D., on Tuesday, Nov. 1 in the presentation “Early Feasibility of a Percutaneous Tricuspid Valve Annuloplasty System for Symptomatic Chronic Functional Tricuspid Regurgitation: 30-Day Results From the SCOUT Trial.”

The company will also host a sponsored symposium, “Trialign: The New Era of Tricuspid Repair,” on Oct. 30. The faculty include Hahn, Martin Leon, M.D., Azeem Latib, M.D., Scott Lim, M.D., Gorav Ailawadi, M.D., Charles Davidson, M.D., Christopher Meduri, M.D. and Joachim Schofer, M.D.

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.

It is estimated that 50 percent of patients with mitral regurgitation have moderate to severe tricuspid regurgitation2. The annual incidence of patients with TR is increasing, with an estimated 220,000 patients in the U.S. and 330,000 patients in the EU developing moderate-severe TR each year3.

Despite the large prevalence of patients, TR is generally untreated by surgery, with approximately 10,000 tricuspid valve surgeries performed annually in the United States4. Annuloplasty repair is the most used technique for tricuspid valve surgery and represents 90 percent of the current volume. Isolated tricuspid valve surgery is particularly rare representing only 10 percent of current procedures while the remaining 90 percent are performed in conjunction with other left-heart surgeries4, 5.

For more information:


  1. Stuge O., Liddicoat J., et al. JTCS 2006;132:1258-61
  2. Argarwal et al. Circ Cardiovasc Interv 2009;2:565-573
  3. Tricuspid Regurgitation Global Strategic Market Assessment. Dymedex Consulting. 2016
  4. STS Adult Cardiac Surgery Database Executive Summary. 2014
  5. Armen K. et al. Ann Thorac Surg. 2013;96:1546–52

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