Edwards Lifesciences (Irvine, California) reported the completion of enrollment in its 1,040-patient randomized controlled investigational device exemption (IDE) study of its Sapien transcatheter heart valve. The company also said Monday it received FDA IDE approval for non-randomized continued access to the Sapien valve for actively enrolling PARTNER (Placement of AoRTic traNscathetER) valves sites.

"Completing enrollment in the PARTNER trial is a key milestone on the path to U.S. approval for the Edwards Sapien valve," Mike Mussallem, CEO/chairman of Edwards Lifesciences, told Medical Device Daily in an email response to questions. "This is very exciting news – we applaud the investigators at the study sites for their significant efforts during the last several years, and we're extremely pleased that they will have the opportunity to continue to treat high-risk aortic stenosis patients with the Edwards Sapien valve under non-randomized continued access."

Mussallem said Edwards expects FDA approval sometime in the 2011 timeframe.

"High-risk patients with severe aortic stenosis are in urgent need of intervention because of the progressive nature of their disease. They are very sick – half of people with untreated severe AS will die within an average of two years after the onset of symptoms – and currently have very few or no treatment alternatives," Mussallem said. "Through the non-randomized continued access approved by the FDA, patients enrolling in the PARTNER trial will have access to this life-saving technology during the follow-up period. This is significant news for U.S. patients."

Edwards initiated its PARTNER trial in the U.S. in 2007 to evaluate patients who are considered high risk or inoperable for conventional open-heart surgery (Medical Device Daily, March 22, 2007). That same year the company received the CE mark to sell the device in Europe. According to Edwards, it is the only company to have both transfemoral and transapical transcatheter valve delivery systems commercially available in Europe. At EuroPCR in May, Mussallem told MDD that the company sold $50 million Sapien valves in 2008 and that it expected to sell more than $100 million this year (MDD, May 29, 2009).

"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, MD, interim surgeon-in-chief and chief of cardiothoracic surgery at New York-Presbyterian Hospital/Columbia University Medical Center (New York), the Calvin Barber Professor of Surgery at Columbia University College of Physicians and Surgeons (New York), and co-principal investigator for the trial.

The multi-center PARTNER 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 Leon, MD, associate director of the Cardiovascular Interventional Therapy program at New York-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.

"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," Larry Wood, Edwards corporate VP of transcatheter valve replacement, said in a company statement. "We also applaud the trial's investigators for their significant efforts in meeting this important milestone."

The company said new clinical data on the Sapien valve would be presented at the 21st annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco beginning Sept. 21.

Last year, the FDA approved the addition of Edwards' Ascendra transapical delivery system to its PARTNER trial. At the same time, the agency gave the company permission to increase its trial sample size from 600 to 1,040 patients. Prior to the Ascendra being added to the trial, clinicians in PARTNER delivered the Sapien valve using the company's RetroFlex transfemoral delivery system by making a small incision in the patient's groin and threading the catheter up through the femoral artery. The Ascendra transapical delivery system delivers the valve by surgically inserting it between the patient's ribs and entering through the bottom part of the heart (MDD, Jan. 30, 2008).

Amdanda Pedersen, 229-471-4212; amanda.pedersen@ahcmedia.com