Early Human Cases With Edwards FORMA Tricuspid Repair System Presented At TCT
SAN FRANCISCO, Oct. 14, 2015 /PRNewswire/ -- 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 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," 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.
Rodes-Cabau is a consultant to Edwards Lifesciences.
1 Campelo-Parada F et al. First-in-man Experience of a Novel Transcatheter Repair System for Treating Severe Tricuspid Regurgitation, Journal of the American College of Cardiology (2015), doi: 10.1016/j.jacc.2015.09.068.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring, enabling them to save and enhance lives. Additional company information can be found at www.edwards.com.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements made by Dr. Rodes-Cabau and statements regarding the potential need for, and features, safety, and benefits of, the FORMA system. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unanticipated outcomes following longer term and expanded clinical experience and rigorous clinical trials. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2014. These filings, along with important safety information about our products, may be found at www.edwards.com.
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