Mitralign said today that the FDA approved a U.S. feasibility study of its tricuspid valve repair device, under an investigational device exemption.
Tewksbury, Mass.-based Mitralign did not provide any details on the Scout study or its design for its percutaneous tricuspid valve annuloplasty device, other than that it will occur at “select” sites in the U.S.
Mitralign, which last year reported the 1st-in-human use of its replacement tricuspid valve, had raised about $50 million as of September 2014. 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).
The tricuspid valve separates the heart’s right atrium and right ventricle. The Mitralign system is designed to use wire and catheters to implant polyester anchors within the valve’s annulus; those 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. Mitralign stitched up an $8 million equity round in June 2014.
“Percutaneous repair of the tricuspid valve represents one of the largest remaining unmet needs in the structural heart space,” CEO Rick Geoffrion said in prepared remarks. “We mimic a known surgical procedure but do not require open heart surgery, providing a potential treatment option for a large number of patients that are too sick for surgical intervention. This approval from the FDA demonstrates their continued commitment to encouraging medical device innovation to address clinical needs and improve patient care.”
“Even though the first group of patients treated were very sick, compassionate use candidates in Europe, the system has shown an excellent safety profile along with tremendous improvements in significant clinical measures,” added Dr. Rebecca Hahn of New York’s Columbia University Medical Center and Presbyterian Hospital, principal investigator in the Scout study. “This patient population has very limited options, and the possibility of performing a transcatheter repair is very exciting. This innovation has significant potential to be a first line therapy.”