Edwards Data Supports Sapien M3 Mitral, Evoque Tricuspid Valves

Edwards Lifesciences shared data that showed successful patient outcomes supporting its portfolio of mitral and tricuspid therapies at this week’s Transcatheter Cardiovascular Therapeutics (TCT) conference.

One-year data from the company’s ENCIRCLE single-arm pivotal trial reached all primary and secondary endpoints for safety and effectiveness, with outcomes published in The Lancet. Thirty-day data from the Evoque system STS/ACC TVT registry also outperformed results from the TRISCEND II pivotal trial.

ENCIRCLE trial results

One-year outcomes in the trial’s main cohort of 299 patients showed low rates for death and low heart failure hospitalization for patients treated with the Sapien M3 transfemoral transcatheter mitral valve replacement (TMVR) system.

Patients receiving Sapien M3 also achieved mitral regurgitation (MR) elimination (95.7% MR ≤ 0/1+) and improvements in symptoms and quality of life. David Daniels, M.D., Sutter West Bay Medical Group cardiologist, principal investigator and structural heart section chief of Sutter’s Heart & Vascular Service Line said although MR is highly prevalent, many patients don’t have good treatment options for mitral interventional and too many are left untreated.

These patients often experience symptoms that are life threatening and significantly impact their quality-of-life,” Dr. Daniels told the press. “These ENCIRCLE trial data demonstrate the near elimination of significant mitral regurgitation, drastically improved quality-of-life, and a very low 30-day mortality in patients receiving a fully percutaneous mitral valve replacement using the SAPIEN M3 system. This is a significant step forward in the treatment of these patients.”

Evoque system registry data

Data from 1,034 patients was evaluated—findings from the Evoque TTVR system STS/ACC TVT Registry showed a positive real-world safety profile in a broad tricuspid patient population.

This includes lower reported pacemaker rates (14.9%) and very low major or life-threatening bleeding rates (1.3%) at thirty days compared to the TRISCEND II pivotal trial. Almost all patients (98%) experience tricuspid regurgitation (TR) elimination and were sent home after a median stay of two days post-procedure.

“We now have established a comprehensive portfolio of mitral and tricuspid repair and replacement technologies to ensure patients can receive the right therapy to meet their unique needs,” said Daveen Chopra, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies. “The depth and breadth of evidence across our therapies reinforces the compounding value our innovations continue to deliver for patients, physicians and the healthcare system.”

Sapien M3 was approved in Europe in April and isn’t yet approved in the U.S. Evoque is approved in the U.S. and Europe.