Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that details on the 13 first-in-human compassionate use cases with its FORMA transcatheter tricuspid repair system were presented at the 27th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. The results of the first seven cases were also published online this week in the Journal of the American College of Cardiology.
"Moderate-to-severe tricuspid regurgitation (TR) is present in an estimated 1.6 million Americans, 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," said Josep Rodes-Cabau, MD, Quebec Heart & Lung Institute, Laval University. "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."
All 13 of the patients discussed at TCT presented with severe functional TR and were determined to be high risk and deemed unsuitable for surgery by a heart team. All had clinical signs of heart failure. Twelve of the 13 patients had successful implantation of the FORMA system. There were no deaths and no major clinical complications reported in any of the 13 patients.
The investigators concluded from their early experience that transcatheter reduction of functional TR appears safe and feasible with the FORMA repair system and TR reduction was observed in all successfully implanted patients, along with improvements in peripheral edema and functional status. They noted that longer-term follow up and larger studies are required to confirm these preliminary results.
The FORMA system is designed to reduce tricuspid regurgitation by occupying the regurgitant orifice area and providing a surface for the coaptation of the valve's native leaflets. The device consists of a foam-filled polymer balloon "spacer" and a rail that is anchored at the right ventricular apex. Implantation is performed via left axillary vein access. The FORMA system has been designed to be fully retrievable during all stages of the procedure, if needed, until sheath removal.
Clinical study planning is underway for an Early Feasibility Study in the United States, as well as a multi-center European and Canadian study. The FORMA system is an investigational device and not for sale in any country.
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