US-based Edwards Lifesciences has obtained CE Mark approval in Europe for Sapien 3 valve, the latest in its line of Sapien transcatheter aortic valve implantation systems.
The company is now initiating the launch of its Sapien 3 transcatheter aortic valve in the EU.
The Edwards Sapien 3 valve features an outer skirt, a cuff of fabric surrounding the valve frame, which prevents valve leakage.
In the two first-in-human feasibility studies, the device showed elimination of significant paravalvular leak during transcatheter aortic valve implantation.
Edwards Lifesciences claims that Sapien 3 valve is the only commercial transcatheter heart valve that can be delivered through a low-profile 14 French expandable sheath (eSheath), which has shown through early clinical experience a low-rate of complications.
The valve can be implanted through multiple approaches, including transfemoral, transapical or transaortic. After implantation, the discreet valve anchors in the aortic annulus.
Edwards Lifesciences transcatheter heart valves corporate vice-president Larry L Wood said: "It has a unique design intended to provide a simpler procedure, along with fewer post-procedural complications and a faster recovery for patients.
"Based on our clinical leadership in transcatheter heart valves, we believe the Sapien 3 valve’s characteristics and procedural refinements have the potential to transform TAVI for both physicians and patients."
In the US, the company has recently obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a clinical trial of the Sapien 3 transcatheter aortic heart valve in the treatment of intermediate risk patients with severe symptomatic aortic stenosis.
The single-arm, non-randomised US study will enrol approximately 1,000 patients with a Society of Thoracic Surgeons score of 4%-8%, which indicates the average predicted risk of operative mortality at 30 days. All enrolled patients can receive a Sapien 3 valve.
Edwards Lifesciences has also announced the completion of patient enrolment in the US study of Sapien 3 valve in the treatment of high-risk or inoperable patients.
The Sapien 3 valve is an investigational device in the US and is not available commercially in the country. The device is being studied in the PARTNER II trial.
Image: Edwards’ Sapien transcatheter heart valve Model 9000TFX and accessories. Photo: courtesy of US Food and Drug Administration.