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Sapien XT FDA approved for high-risk, inoperable patients
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Edwards Lifesciences has announced that its second-generation transcatheter valve, Sapien XT, has received FDA approval for the treatment of high-risk and inoperable patients with severe aortic stenosis.
The Sapien XT valve features a lower-profile system compared with the Sapien valve, which has been available in the United States for high-risk and inoperable patients since October 2012. The new valve also includes a 29 mm valve size for patients with a large native annulus, allowing for the treatment of more patients.
In addition to the valve, the NovaFlex+ transfemoral delivery system with a low-profile 16F expandable sheath (eSheath) and the Ascendra+ transapical and transaortic delivery systems will also be immediately available to patients at leading CV centers in the country, according to a press release.
Martin B. Leon
“There is a substantial and growing body of evidence that the Sapien XT valve benefits both high-risk and inoperable patients, and clinicians have documented these consistently positive results in both randomized studies and European country registries,” Martin B. Leon, MD, director, Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center and professor of medicine at the Columbia University College of Physicians and Surgeons, said in a press release. “The results from the PARTNER II trial in treating US inoperable patients with the Sapien XT valve demonstrated a reduction in complications with the TAVR procedure, and improved patient outcomes over earlier trials.”
Specifically, the primary endpoint of PARTNER II — a composite of mortality, stroke and rehospitalization at 1 year — did not differ between study groups (Sapien XT, 33.9% vs. Sapien, 34.7%; noninferiority P=.0034). Differences in each individual endpoint of all-cause mortality, disabling stroke and rehospitalization also did not reach statistical significance. However, major vascular complications, especially perforations, dissections and hematomas, were lower in the Sapien XT arm (9.6% vs. 15.5%; P=.04).
The Sapien XT valve has been available in Europe since 2010 and Japan, with regulatory and reimbursement approval, since 2013.
Perspective
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Faisal G. Bakaeen, MD
The news about the expansion of the CoreValve label to treat high-risk surgical patients and the approval of the Sapien XT valve is certainly welcome by US physicians. Now, there are more options available to treat patients with severe aortic stenosis who are at significant risk for traditional surgical aortic valve replacement. In addition, the vascular complication rates are likely to decrease and there will be a wider use of total percutaneous transfemoral approaches with the XT generation compared to the original Sapien model.
In general, what we are witnessing now is one of many steps towards having TAVR technology amenable to a wider pool of patients with different aortic annular and vascular access dimensions and anatomies. Future steps will be defined by lower profile delivery systems and smarter valves that will improve outcomes and reduce complications, including paravalvular leaks.
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