Mitralign said today that it enrolled the 1st patient in the Scout feasibility trial of its Trialign tricuspid valve repair device under an investigational device exemption.
The Tewksbury, Mass.-based company’s Trialign device is designed to use wire and catheters to implant polyester anchors within the annulus of the tricuspid valve, which separates the heart’s right atrium and right ventricle.
The anchors are then cinched together to reduce the circumference of the mitral valve, creating a functional bi-cuspid valve. Earlier this year, the company closed enrollment in European trials aimed at winning CE Mark approval there for a mitral regurgitation indication.
The 1st procedure in the Scout study was performed by principal investigator Dr. Rebecca Hahn and Dr. Susheel Kodali, both of New York’s Columbia University Medical Center and Presbyterian Hospital, Mitralign said.
The 2-year study, which aims to enroll 15 patients, is a prospective, single-arm, multi-center trial. The primary endpoint is technical success at 30 days, defined as freedom from death with successful access, delivery and retrieval of the device delivery system; deployment and correct positioning of the intended device(s); and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure, according to ClinicalTrials.gov.
Final data collection on the primary endpoint is slated for May 2018, with an overall completion date a year later.
“We are extremely excited to be pioneering a novel solution in percutaneous repair for the tricuspid valve,” Hahn said in prepared remarks. “Given the reports that operative mortality for tricuspid valve replacement surgery can top 30%, coupled with the lack of treatment options, this system represents a very welcome advancement.”
“An estimated 1.6 million patients suffer from tricuspid regurgitation in the U.S., yet little progress has been made developing tricuspid specific therapies,” added Mitralign CEO Rick Geoffrion. “We are proud to be at the forefront of transcatheter repair for tricuspid regurgitation.”
Mitralign, which last year reported the 1st-in-human use of its replacement tricuspid valve, had raised about $50 million as of September 2014, after stitching up an $8 million equity round in June of that year. The company is backed by a mix of venture capital and strategic medical device investors, including Forbion Capital Partners, Orchestra Medical Ventures, Oxford Bioscience Partners, Triathlon Medical Ventures, Medtronic (NYSE:MDT) and Johnson & Johnson (NYSE:JNJ).