First-in-Human Cases With Edwards' Forma Tricuspid Repair System Presented at TCT

October 19, 2015—Edwards Lifesciences Corporation recently announced that details on the 13 first-in-human compassionate-use cases with its Forma transcatheter tricuspid repair system were presented at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation, held October 11–15, in San Francisco, California. The results of the first seven cases have been published online ahead of print by Francisco Campelo-Parada, MD, et al in the Journal of the American College of Cardiology.

According to the company, all 13 of the patients discussed at TCT presented with severe functional tricuspid regurgitation 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.

From their early experience, the investigators concluded that transcatheter reduction of functional tricuspid regurgitation appears safe and feasible with the Forma repair system. Tricuspid regurgitation 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.

Edwards’ 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.

The company advised that clinical study planning is underway for an early feasibility study in the United States, as well as a multicenter European and Canadian study. The Forma system is an investigational device and not for sale in any country.

In the Edwards Lifesciences press release, Josep Rodés-Cabau, MD, commented, “Moderate-to-severe tricuspid regurgitation is present in an estimated 1.6 million Americans, yet isolated tricuspid valve surgery is extremely rare. Severe tricuspid regurgitation is an under-recognized and under-treated condition, and it is associated with a poor prognosis."

Dr. Rodés-Cabau, who is from the Quebec Heart & Lung Institute at Laval University in Quebec City, Quebec, added, “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 tricuspid regurgitation.”