Mitralign said today that surgeons in Germany implanted its tricuspid valve repair device in its 1st patient, under a "compassionate use" allowance in Germany.
Mitralign said its system allows cardiologists to treat tricuspid regurgitation in the valve separating the heart’s right atrium and right ventricle in a minimally invasive percutaneous procedure. The system uses wires and catheters to implant polyester anchors within the tricuspid valve’s annulus, a ring of tissue surrounding the valve. Those anchors are then cinched together to reduce the circumference of the mitral valve closer to its normal size, creating a functional bi-cuspid valve, according to a press release.
Tricuspid regurgitation occurs when the tricuspid valve fails to open and close properly, causing blood to flow backward into the right atrium. If left untreated, TR can lead to heart enlargement and heart failure. Traditional treatments include medical therapy or open heart surgery for the estimated 1.6 million U.S. patients with the condition.
Earlier this year, Mitralign completed enrollment in European trials as it seeks CE Mark clearance there for a mitral regurgitation indication. Tewksbury, Mass.-based Mitralign said the successful use of the device in a tricuspid valve repair was done at the Albertinen Heart Center in Hamburg.
"We continue to see more and more patients presenting with tricuspid regurgitation and to date, we have not had an interventional device available to treat these patients," Dr. J. Schofer of the Albertinen Heart Center said in prepared remarks. "This is perhaps the most important intervention I have ever performed. It is the very 1st percutaneous tricuspid annuloplasty and it was performed successfully; dramatically reducing TR with a single small implant and improving the outcome for a patient who would have had a 30% chance of mortality with surgery. I expect that in the future, this will become an outpatient procedure as we start to treat more and more patients in this manner."
Mitralign has raised $50 million to date, 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).
"Tricuspid valve disease can have serious implications for the patient, yet it is rarely treated by surgeons, who tend to prioritize the mitral valve for primary surgical treatment," added Mitralign CEO Rick Geoffrion. "Our technology can eliminate the need to choose 1 valve over the other."