News | September 03, 2009

Edwards Completes Enrollment in U.S. Trial for Transcatheter Heart Valve

September 2, 2009 – Edwards Lifesciences Corp. said this week it completed enrollment in its 1,040-patient randomized controlled investigational device exemption (IDE) study of the Edwards SAPIEN transcatheter heart valve.

In addition to completing enrollment in both the surgical and nonsurgical arms of the PARTNER Trial, Edwards received U.S. Food and Drug Administration (FDA) IDE approval for nonrandomized continued access to the Edwards SAPIEN valve for actively enrolling PARTNER sites.

"It's exciting that the clinical community will soon have the opportunity to make an informed evaluation of this treatment against conventional therapies that may not be realistic options for high-risk patients with severe aortic stenosis," said Craig Smith, M.D., interim surgeon-in-chief and chief of cardiothoracic surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center, the Calvin F. Barber, professor of surgery at Columbia University College of Physicians and Surgeons, and coprincipal investigator for the trial.

The multicenter PARTNER (Placement of AoRTic traNscathetER valves) Trial assigns patients into one of two arms: a "nonsurgical" arm, in which the Edwards SAPIEN valve is compared to non-surgical treatments, and a "surgical" arm, in which the Edwards SAPIEN valve is compared to traditional surgical aortic valve replacement. The primary endpoint for the PARTNER Trial is based on one-year follow-up of each patient enrolled; this evaluation has been underway and is continuing.

"The PARTNER Trial has brought together multidisciplinary clinical teams aligned around the mission of addressing the serious problem of aortic stenosis by treating patients with a far less invasive, transcatheter approach," said Martin B. Leon, M.D., associate director of the Cardiovascular Interventional Therapy (CIVT) Program at NewYork-Presbyterian Hospital/Columbia University Medical Center, professor of medicine at Columbia University College of Physicians and Surgeons, and coprincipal investigator for the PARTNER Trial.

Edwards is the only company to have both transfemoral and transapical transcatheter valve delivery systems commercially available in Europe. The Edwards SAPIEN valve was approved for sale in Europe in late 2007, and has been used in the treatment of thousands of high-risk patients and evaluated as part of nine rigorous scientific studies. New clinical data on the Edwards SAPIEN valve will be presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, Sept. 21-25.

For more information:

Related Content

Pregnancy-Related Heart Failure Strikes Black Women Twice as Often as Other Races
News | Womens Healthcare| October 19, 2017
African American women were found to be twice as likely to be diagnosed with peripartum cardiomyopathy as compared to...
MRI May Predict Neurological Outcomes for Cardiac Arrest Survivors
News | Sudden Cardiac Arrest| October 18, 2017
Magnetic resonance imaging (MRI)-based measurements of the functional connections in the brain can help predict long-...
Xarelto Significantly Reduces Major Cardioavascular Events in Stable CAD and PAD Patients
News | Pharmaceuticals| October 18, 2017
October 18, 2017 — Results from the pivotal Phase 3 COMPASS study found that the...
First Patient Enrolled in U.S. Arm of ALIVE Pivotal Heart Failure Trial
News | Heart Failure| October 17, 2017
October 17, 2017 — BioVentrix Inc. recently announced enrollment of the first patient in the U.S.
Appropriate Use Criteria Published for Valvular Heart Disease Imaging Tests
News | Clinical Decision Support| October 16, 2017
The American College of Cardiology (ACC), along with several partnering societies, recently released appropriate use...
Low Mortality and Stroke Risks Displayed for Minimally Invasive Aortic Valve Replacements
News | Heart Valve Technology| October 11, 2017
An analysis of more than 1,000 minimally invasive aortic valve replacements and more than 400 additional associated...
New Evaluation Sends Low-Risk ER Chest Pain Patients Home Sooner
News | Cardiac Diagnostics| October 10, 2017
A new evaluation to determine whether emergency room patients with chest pain can go home and follow up with their...
News | Pharmaceuticals| October 04, 2017
October 4, 2017 — MyoKardia Inc.
Medtronic Announces Post-Market Study for CoreValve Evolut Pro System
News | Heart Valve Technology| October 02, 2017
Medtronic plc recently announced a new post-market clinical study to evaluate its CoreValve Evolut Pro valve in...
BioCardia Announces 12-Month Results from TRIDENT Trial of Stem Cell Delivery System
News | Stem Cell Therapies| September 26, 2017
BioCardia Inc. recently announced 12-month results from the Phase II TRIDENT clinical trial, conducted by the...
Overlay Init