TriClip Gets CE Mark for Transcatheter Tricuspid Valve Repair

Megan Brooks

April 10, 2020

Abbott's TriClip Transcatheter Tricuspid Valve Repair System has received European CE Mark approval as a nonsurgical treatment option for tricuspid regurgitation (TR), the company has announced. It said the TriClip is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available anywhere.

Although the TriClip uses the same technology Abbott uses for the company's successful MitraClip, designed to treat mitral regurgitation, its delivery system is designed specifically for the tricuspid valve. A steerable guiding catheter system adapts to the right side of the heart, allowing the physician to grasp and clip the leaflets of the tricuspid valve, Abbott said. It comes in two sizes: NT and XT.

The European approval is based on positive 6-month data from the TRILUMINATE study, published November 17, 2019 in the Lancet, in which 85 patients with TR was moderate or more severe underwent successful TriClip implantation.

At 30 days, severity of tricuspid regurgitation was reduced by at least one grade in 86% of 83 patients with available echocardiograms and other imaging results. That exceeded the prespecified performance goal of 35% (P < .0001).

At 6 months, 6% of 84 patients experienced a major adverse event, which was less than the prespecified performance goal of 39% (P < .0001).

There were no periprocedural deaths, conversions to surgery, device embolizations, or strokes; 5% of patients had died by 6 months.

Earlier results from the trial had been reported at the Congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) in 2019 and covered at the time by theheart.org | Medscape Cardiology.

The device remains investigational in the United States.

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