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FDA gives thumbs up for Sapien XT heart valve by Edwards Lifesciences

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Medical equipment company Edwards Lifesciences has announced that U.S. health regulators have green-lighted its second generation transcatheter aortic valve replacement (TAVR) device for individuals with severe symptomatic aortic stenosis (AS) who are too weak to undergo open heart surgery.

In a statement released Monday, Edwards Lifesciences, which specializes in artificial heart valves and hemodynamic monitoring, said that the U.S. Food and Drug Administration (FDA) has approved its Sapien XT TAVR system, for the treatment of patients whose conditions put them at high risk to be eligible for open heart surgery.

Aortic stenosis occurs when the aortic valve of the heart narrows. The condition, which affects two percent of individuals over 65 years old and three percent of those over 75 years old, could cause blood clots, heart failure and premature death. Doctors often recommend surgery to repair or replace the diseased valve to patients who develop symptoms.

Unlike the traditional and standard open heart surgery, TAVR requires minimal incisions for replacing the damaged heart valves. Martin Leon, from the Columbia University College of Physicians and Surgeons and one of the investigators of the PARTNER II Trial, which assessed the safety and effectiveness of the SAPIEN XT, said that evidence shows that the TAVR system can benefit high-risk and inoperable patients.

"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," Leon said.

The SAPIEN XT is already commercially available in Europe since four years ago but following the FDA approval, Edwards has its eyes on making the device available to U.S. patients soon.

"The Edwards SAPIEN XT 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 company said in a statement.

Edwards's XT, which has a smaller catheter compared with that of the first generation Sapien, will compete with Medtronic CoreValve that has earlier gotten the nod of the FDA for use in patients who may be healthy but are still at high risk for open heart surgery.

In May this year, Medtronic agreed to pay over $1 billion to Edwards Lifesciences as settlement for patent infringement on transcatheter heart valves. The settlement would allow Medtronic's CoreValve to remain available in the market.

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