Staff Writer

Edwards Lifesciences (Irvine, California) is reporting that it has received an additional indication for its Sapien XT transcatheter heart valve in Europe. The company received the CE mark for use of the device for valve-in-valve procedures.

Specifically, the company received European approval to provide a minimally invasive treatment option for patients whose surgical mitral or aortic valves require replacement, and who are at extreme risk for surgery.

"With this approval, Edwards is the only company with a valve-in-valve indication in Europe for the mitral position, which addresses an unmet need within the clinical community to provide an alternative to a high-risk surgery," Sara Huoh, a spokesperson for Edwards, told Medical Device Daily via e-mail. "It is possible that without a valve-in-valve option to replace a bioprosthetic mitral valve, patients may go untreated. We are very pleased to be able to offer this treatment option for European patients who have previously received a bioprosthetic valve in the aortic or mitral position, and are at high risk for an additional valve replacement surgery.

More than 300,000 valve replacements are performed worldwide each year through open-heart surgery, utilizing either bioprosthetic tissue valves or mechanical valves.

Edwards' family of Perimount bovine pericardial tissue valves have been the world's most frequently implanted valves for more than 30 years, which surgeons have increasingly chosen over mechanical valves, even in younger patients. Patients who receive Edwards' bovine pericardial valves are generally not required to be on lifelong anticoagulation therapy (blood thinners), as they would if they had received a mechanical valve. Decades of clinical experience and peer-reviewed data on Edwards' valves provide robust evidence of long-term performance and optimal hemodynamics of the Perimount valve platform.

"Just as native heart valves experience wear over time, bioprosthetic valves eventually degenerate, too, creating a need for a replacement valve," said Olaf Wendler, MD, PhD, professor of cardiac surgery, King's College Hospital (London), and one of the principal investigators of the SOURCE XT Registry. "The European adoption of valve-in-valve procedures using SAPIEN XT is an important development for treating patients who may otherwise go untreated. In particular, patients needing a re-operation to address a failing mitral valve face a very challenging surgery, and the ability to offer a transcatheter replacement is extremely important for this patient group."

"The European approval of the SAPIEN XT system for valve-in-valve procedures is a milestone achievement. While this is not a large financial opportunity, it represents an important benefit for patients unable to go through a second open-heart surgery to replace their failing bioprosthetic valves," said Larry Wood, Edwards' corporate vice president, transcatheter heart valves.

The company has not yet received approval for the device in the U.S. and notes that it is currently being studied as part of the randomized, pivotal PARTNER II Trial.

"While we have not specified anticipated timing on a valve-in-valve indication for the SAPIEN XT valve in the U.S., we are hopeful that this option will be available to American patients in the future," Huoh, told MDD, via e-mail.

In an investor call held Monday, Edwards said that in transcatheter valves, it's continuing to actively work with the FDA to obtain approval of the Sapien XT valve in the U.S.

Consistent with prior assumptions; the company said that it was anticipating approval over the next few months. The firm said that the device, which is currently the leading transcatheter valve in Europe, would be a welcome upgrade for U.S. physicians and patients and that it anticipates a rapid adoption once it becomes available.

The news of this indication comes on the heels of the company announcing the launch of its the Sapien 3 valve in Europe (Medical Device Daily, Jan. 28, 2014). The company said that the new valve has an outer skirt – a cuff of fabric surrounding the valve frame - providing a seal to address paravalvular leak. The effectiveness of this solution is supported by the limited clinical experience, as detailed in two first-in-human feasibility studies, which demonstrated that significant paravalvular leak was eliminated during transcatheter aortic valve implantation (TAVI).

Earlier last month, the firm reported receiving Investigational Device Exemption approval from the FDA to initiate a single-arm, non-randomized clinical trial of the Sapien 3 transcatheter aortic heart valve in the treatment of intermediate risk patients with severe symptomatic aortic stenosis. The company also completed enrollment in its U.S. clinical trial studying the Sapien 3 valve in the treatment of high-risk or inoperable patients (MDD, Jan. 14, 2014).

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