The single-arm, non-randomized study of up to 1,000 patients will examine the next iteration of Edwards’ Sapien transcatheter aortic valve implant, designed to correct the "paravalvular leakage" problem that’s plagued early TAVI versions made by Edwards and its peers in the replacement valve market.
Edwards also said it’s completed enrollment in another trial of the Sapien 3 device, in patients deemed too sick to undergo open heart surgery.
Although the Sapien 3 device isn’t approved for sale anywhere, Irvine, Calif.-based Edwards said it expects to win CE Mark approval in the European Union for the device " in the near future."
"The Sapien 3 valve is a significant advancement, and we’re excited to make progress toward bringing this sought-after transcatheter therapy to U.S. patients. It represents a big step toward fulfilling the promise of a simpler procedure with fewer complications and faster patient recovery," transcatheter heart valves vice president Larry Wood said in prepared remarks. "Last year, we completed enrollment in the first U.S. randomized controlled trial involving intermediate risk patients with severe aortic stenosis. This unique dataset of 2,000 patients receiving surgery or transcatheter valve replacement will provide a thorough baseline comparison for this new study of the Sapien 3 valve in intermediate risk patients."
Edwards CEO Michael Mussallem is slated to address the J.P. Morgan Healthcare conference later today. MassDevice.com will have complete coverage of the conference – stay tuned.