FDA Approves Sapien Transcatheter Valve for Inoperable Aortic Stenosis

The US Food and Drug Administration (FDA) has approved the Sapien Transcatheter Heart Valve as the first percutaneously delivered artificial valve in the United States for use in patients with severe aortic stenosis who are ineligible for surgery.

This decision follows the results of the PARTNER (Placement of AoRTic TraNscathetER valve) trial published in 2010, showing that transcatheter aortic valve replacement (TAVR) using the Edwards Sapien device (Edwards Lifesciences, Irvine, CA) reduces all-cause mortality and repeat hospitalization compared with standard therapy, although the risk of stroke and vascular complications is higher.

The device, made of cow tissue and polyester supported with a stainless steel mesh frame, is indicated for patients similar to those in Cohort B of the PARTNER trial “who are not eligible for open-heart surgery for replacement of their aortic valve and have a calcified aortic annulus,” according to the FDA press release. “The product label advises that a heart surgeon should be involved in determining if the Sapien [device] is an appropriate treatment for the patient.”

Patients who are not eligible include those who can be treated with open surgery, those who have congenital heart valve anomalies, masses, or infections, and those who cannot tolerate anticoagulation/antiplatelet therapy, according to the press release.

Though similar to devices approved for use in parts of Europe, the Sapien valve is different in that “the diameter of the delivery system is the older version,” Martin B. Leon, MD, of Columbia University Medical Center (New York, NY) told TCTMD in an interview.

High Consideration for Thorough Training

The device will be launched in a controlled and disciplined manner, noted Dr. Leon, co-principal investigator of the PARTNER trial. He emphasized the importance of appropriate patient selection and proper training for physicians performing the procedure.

“Right now Edwards is feverishly working with many sites, including Columbia, to develop a training program for qualified sites,” he said. “Site qualification is based upon experience, commitment to taking care of these sick patients, and the availability of a team approach that includes surgeons, interventionalists, and cardiologists all working together.”

Currently, the roughly 30 sites that participated in the PARTNER trial are trained and will have access to the device. According to Dr. Leon, Edwards plans to train 4 new centers a week and aims to continue expanding based on the quality of the results.

However, exact stipulations and training criteria for operators have not been determined, pending the national coverage decision from the Centers for Medicare and Medicaid Services.

Dawn of a New Era

Dr. Leon said he “expected that [the approval] could happen any time,” and plans to perform the first TAVR procedure outside of a clinical trial in the United States on November 4, 2011, with his team, which recently completed its 303rd transcatheter valve procedure. They plan to present the results of this case in the next week at the upcoming 2011 Transcatheter Cardiovascular Therapeutics symposium in San Francisco, CA.

“For Columbia, this is a big thing,” he said. “We’ve been working on this technology for 6 years and have developed a focused group. The fact that our team has evolved to the leadership of this procedure has been very exciting.”

In the end, this approval will have a great impact on patients with aortic valve stenosis without the option of surgery, Dr. Leon predicted.

“It’s very exciting that finally we have access to a device that has been shown to improve survival in these very sick patients,” he said. “I think it means everything to a patient population that really has hoped for this. From the aspect of the American physician, the approval is extremely important.”

Note: Dr. Leon is a faculty member of the Cardiovascular Research Foundation, which owns and operates TCTMD.


US Food and Drug Administration. FDA approves first artificial aortic heart valve placed without open-heart surgery [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278348.htm. Published November 2, 2011. Accessed November 3, 2011.



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  • Dr. Leon reports no relevant conflicts of interest.