Edwards Completes SAPIEN Trial Enrollment, Gets FDA Support
In case you missed it, there was some pretty big news earlier this week regarding Edwards Lifesciences and their minimally invasive aortic valve replacement technology known as SAPIEN. Here are the details:
Edwards Lifesciences Corporation, the world leader in the science of heart valves, today announced completion of 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 non-surgical arms of the PARTNER Trial, Edwards received U.S. Food and Drug Administration (FDA) IDE approval for non-randomized 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 New York-Presbyterian Hospital/Columbia University Medical Center.
The multi-center PARTNER (Placement of AoRTic traNscathetER valves) Trial assigns patients into one of two arms: a “non-surgical” 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 multi-disciplinary 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 co-principal investigator for the PARTNER Trial.
Sapien Heart Valve Replacement Device
“These very sick patients need urgent intervention, and we’re extremely pleased that they will continue to have access to this life-saving technology during the follow-up period,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter valve replacement. “We also applaud the trial’s investigators for their significant efforts in meeting this important milestone.”
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 beginning Sept. 21.
Keep on tickin!
About The Blogger: Adam Pick is a double, heart valve surgery patient and author of The Patient’s Guide To Heart Valve Surgery. This unique book integrates the clinical facts of heart valve surgery with the personal experiences of 78 former valve surgery patients to help patients and caregivers better understand the problems, the opportunities and the realities of heart valve surgery. To learn more about Adam and his heart valve surgery book, click here.
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September 5th, 2009 at 5:19 pm
Both my wife and I have finished reading Adam’s book because I’ll be getting a aorta valve replacement. Next week I’ll be getting a cath and a tee so my doctor is being through. I haven’t seen much mentioned about a minimall invasive arotic valve surgery and from what I’ve learned that procedure cuts down the recovery period quite a bit so I think it would be well worth it. I’d like to hear more about this procedure from others.
Thanks and God bless us all.
September 7th, 2009 at 11:22 am
I also considered having miminal invasive surgery. I had an mechanical mitral valve replaced recently. After discussing with two promininent cardiologists, they both recommended the traditional open heart surgery. Also, the surgeon who performed the surgery recommends this because its better for him to see all whats going on inside my chest (behind the heart, etc.) So, I opted for the “old” way vs the “new” way” I feel confident I made the right choice. I was out of the hospital in 10 days and am on the road to recovery! Keep a positive attitude - it really does work!