FDA approves Intuity Elite rapid valve from Edwards Lifesciences

The FDA approved the Intuity Elite rapid deployment replacement aortic valve made by Edwards Lifesciences (NYSE:EW).

Irvine, Calif.-based Edwards said the Intuity Elite valve is designed to create more time during the treatment of complex heart failure cases for procedures to treat other facets of the disease. It’s on the U.S. market now, the company said.

The Intuity Elite valve won CE Mark approval in the European Union in April 2014.

“U.S. approval of the Edwards Intuity Elite valve system is a significant milestone as this technology provides an advanced surgical treatment option for patients suffering from aortic valve disease,” surgical heart valve therapy VP Bernard Zovighian said in prepared remarks. “In partnership with surgeons, Edwards is committed to developing more innovative surgical technologies, like the Edwards Intuity Elite valve system, in order to address patient needs.”

Edwards said the approval was backed by 1-year data from the 839-patient Transform trial of the Intuity Elite device, presented in May at the annual meeting of the American Assn. for Thoracic Surgery. The study showed reduced cross-clamp time and cardiopulmonary bypass time compared to data from the Society of Thoracic Surgeons’ adult cardiac database. New York Heart Assn. functional class improved in 73.1% of patients, according to the Transform data.

“Many patients with aortic stenosis have more than one type of heart disease, most commonly coronary artery disease. The Edwards Intuity Elite valve system enables surgeons to streamline concomitant procedures, which can be beneficial for patients undergoing these longer, more complex surgeries,” Dr. Kevin Accola, of Orlando’s Florida Hospital Cardiovascular Institute, said in a press release.

“Patients request less invasive surgical options, and the Edwards Intuity Elite valve system meets this need by facilitating multiple approaches to minimally invasive operations, which can mean less trauma, early recovery and decreased need for blood transfusions for many patients,” added Dr. Mubashir Mumtaz of PinnacleHealth in Harrisburg, Pa.

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