The announcement was made at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco and data from the 1st 7 patients was published in the Journal of the American College of Cardiology.
The Forma system is designed to occupy the regurgitant orifice area to provide a surface for the coaptation of the valves native leaflets to reduce triuspid regurgitation, Edwards said.
“Moderate-to-severe tricuspid regurgitation is present in an estimated 1.6 million Americans1, yet isolated tricuspid valve surgery is extremely rare. Severe TR is an under-recognized and under-treated condition, and it is associated with a poor prognosis. We are encouraged by our early experience with the Forma system in which a valuable finding was that patients had positive changes in their symptoms and quality of life. We look forward to further study to learn if an isolated tricuspid transcatheter treatment can improve the prognosis for patients with severe TR,” Dr. Josep Rodes-Cabau of Quebec’s Heart & Lung Institute at Laval University said in prepared remarks.
Investigators found that 12 of the 13 patients were successfully implanted with the system, and said that the system “appears safe and feasible” as TR reduction was observed in the implanted patients, according to Edwards.
Investigators added the caveat that a longer-term follow-up and larger studies would be rquired to confirm the preliminary results.
Here’s some other news coming out of the annual Transcatheter Cardiovascular Therapeutics conference: