June 17, 2014 — The U.S. Food and Drug Administration (FDA) approval for its Edwards Sapien XT transcatheter aortic heart valve for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS). This next-generation, lower-profile system, which includes the 29 mm valve size for patients with a large native annulus, will allow for the treatment of more patients. ??
The balloon-expandable valve will be immediately available to patients at leading cardiovascular centers across the nation, along with the NovaFlex+ transfemoral delivery system that can be delivered through a low-profile 16-French expandable sheath (eSheath) and the Ascendra+ transapical and transaortic delivery systems. ?
The Sapien XT is a revised version of their earlier Sapien transcatheter heart valve. It uses a smaller profile delivery system that enables use in patients with smaller or severely diseased vessels. The Sapien XT is also available with an additional, larger size 29 mm valve.
“For the Sapien XT approval, FDA based its decision on clinical data from a randomized clinical study and several, single-arm nested registries, conducted in the U.S.,” said Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “The 560-subject randomized clinical trial showed that, for inoperable patients, the Sapien XT device was as safe and effective as the previously approved Sapien device, with better procedure outcomes and reduced vascular complication rates.”
He said the agency also reviewed clinical data from the European SOURCE XT Registry, Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (TVT) Registry, and peer-reviewed articles that showed the benefits of the Sapien XT device for high-risk patients outweighed the risks of the device.”
“We approved the Sapien XT THV despite observing certain quality system violations during a recent inspection at the Edwards manufacturing facility where the Sapien XT delivery systems and accessories are made,” Shuren said. “Quality system requirements govern the design, manufacture, and distribution of devices, and we conduct such inspections to assure that devices are safe and effective. When violations occur, according to federal law, we cannot approve a company’s medical device — unless, we allow deviation from quality system requirements through what is known as a variance.”
He said this is a rarely used regulatory action that is employed only in special situations of public health need. FDA may grant a variance from any device quality system requirement when the agency determines that it is in the best interest of the public health and that the firm seeking the variance has alternate methods and controls in place sufficient to assure that the device will be safe and effective and otherwise in compliance with the FDA rules.
“We granted Edwards Lifesciences a variance from the quality systems requirements for two reasons. First, we determined that there is an important, immediate need for these technology options and that Sapien XT demonstrates a reasonable assurance of safety and effectiveness for its intended use. This means patients who really need this technology could and should receive it. And second, Edwards Lifesciences presented us with an appropriate variance plan for addressing its manufacturing problems — including specific controls to permit safe use of the Sapien XT while corrections are underway,” Shuren said.
?“There is a substantial and growing body of evidence that the Sapien XT valve benefits both high-risk and inoperable patients, and clinicians have documented these consistently positive results in both randomized studies and European country registries,” said Martin Leon, M.D., director, Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center and professor of medicine at the Columbia University College of Physicians and Surgeons. Leon was the co-principal investigator for the PARTNER II Trial, which was Edwards’ second randomized controlled trial of a transcatheter valve and evaluated the Sapien XT valve. “The results from the PARTNER II Trial in treating U.S. inoperable patients with the Sapien XT valve demonstrated a reduction in complications with the TAVR procedure, and improved patient outcomes over earlier trials.”
??The Edwards Sapien XT valve has been commercially available in Europe since 2010, and received regulatory and reimbursement approval in Japan in 2013.
For more information: www.edwards.com