Sapien™ Represents First TAVR FDA Approval For High Risk Patients

Edwards Lifesciences’ long wait for an extended indication for its Sapien Valve is over with the news that FDA has rubber stamped the guidance from its summer expert circulatory panel meeting.

In short

Edwards Lifesciences Corporation is going head to head with Medtronic in the goldrush to occupy the U.S. transcatheter aortic valve replacement (TAVR) ground. The company has now received approval from the U.S. FDA to treat high-risk aortic stenosis patients with the Edwards™ Sapien™ transcatheter aortic heart valve delivered both transfemorally and transapically. Sapien was the first TAVR device to gain U.S. FDA approval and expectations are high that extending its indications will see its use extended to a significantly larger patient group.

Background

We’ve covered the progress of the TAVR procedure pretty closely, especially the tortuous progress towards FDA approval. Indeed in June we reported that extended indications for Edwards’ Sapien had been given the nod by the FDA’s expert panel, a move which usually presages full agency approval. And now that approval has been granted.

Sapien was first approved in the U.S. almost a year ago, for the treatment of inoperable patients via the transfemoral approach. With the addition of high-risk patients to those eligible for the transcatheter procedure and with the approval of the transapical approach, a considerably broader group can now be treated with the Sapien valve.

Medtronic’s CoreValve® meanwhile remains available in the U.S. on an investigational basis only as the company has only recently completed enrollment in its high risk patient study and its IDE study into patients at intermediate risk of undergoing open surgery only got the nod in late August.

The study underpinning the newly announced Sapien approval

The safety and effectiveness of the Sapien valve were evaluated in a randomised, controlled pivotal study called The PARTNER Trial. Edwards submitted a Premarket Application (PMA) in April 2011 based on data from the high-risk cohort (Cohort A) of The PARTNER Trial. Cohort A compared the outcomes of patients at high risk for traditional open-heart surgery randomised to receive either surgical aortic valve replacement or the Sapien valve via transfemoral or transapical delivery. The trial was successful in meeting its primary endpoint at one year, concluding that survival of high-risk patients treated with the Sapien valve was equivalent to those treated with traditional open-heart surgery.
Company comments

“We are thankful to the multidisciplinary Heart Teams who worked diligently throughout The PARTNER Trial to bring new treatments to U.S. patients at high risk for surgical aortic valve replacement,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves. “It is extremely rewarding for us and our clinical partners to know that high-risk patients suffering from this often debilitating disease will now have access to this life-saving therapy.”

Indication

The Edwards SAPIEN valve is indicated for the treatment of patients with severe symptomatic calcified native aortic valve stenosis who have been examined by a Heart Team, including an experienced cardiac surgeon and a cardiologist, and found to be inoperable or at high risk for traditional open heart surgery, and in whom existing co-morbidities would not preclude the expected benefit from the procedure.

Source: Edwards Lifesciences Corporation.

published: October 22, 2012 in: Approval/Clearance, Cardio, Clinical Studies/Trials

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