FDA Panel Recommends Approval of Edwards Sapien Transcatheter Valve for Treatment of Inoperable Patients

July 20, 2011—Edwards Lifesciences (Irvine, CA) announced that a US Food and Drug Administration advisory panel voted to recommend approval of the Edwards Sapien transcatheter heart valve for the treatment of certain inoperable patients. Edwards submitted a premarket approval application in the fall of 2010 based on data from the inoperable cohort of the PARTNER trial. In the United States, the Edwards Sapien valve is an investigational device and is not yet commercially available. The device is commercially available in Europe, where it received CE Mark approval in late 2007, the company advised.

"We are pleased with the panel's strong recommendation for approval, and would like to thank them for their comprehensive and thoughtful review of the data presented from the PARTNER trial,” commented Michael A. Mussallem, Edwards' Chairman and Chief Executive Officer. “This represents another important step on the path to what we hope will lead to FDA approval of Sapien. We would also like to thank the principal investigators and their heart teams at the PARTNER hospitals for their dedication to this clinical trial, and to their patients for participating in a study of a new therapy."

PARTNER's cohort B compared the outcomes of 358 patients after treatment with either standard therapy or with the Edwards Sapien valve delivered via a transfemoral approach. Martin B. Leon, MD, et al published the cohort B data in The New England Journal of Medicine (2010;363:1597–1607).

In The New England Journal of Medicine, the PARTNER investigators concluded, “In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI [transcatheter aortic valve implantation], as compared with standard therapy, significantly reduced the rates of death from any cause, the composite endpoint of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events.” 

The investigators further stated, “On the basis of a rate of death from any cause at 1 year that was 20 percentage points lower with TAVI than with standard therapy, balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery." The study investigators added, “Aortic stenosis is an insidious disease with a long latency period followed by rapid progression after the appearance of symptoms, resulting in a high rate of death” and that, “standard medical therapy...did not alter the natural history of severe aortic stenosis.”

As detailed in The New England Journal of Medicine, the rate of death at 1 year from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared to 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.4–0.74; P < .001). The rate of the composite endpoint of death from any cause or repeat hospitalization was 42.5% with TAVI compared to 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35–0.59; P < .001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs 58%; P < .001). At 30 days, TAVI, as compared to standard therapy, was associated with a higher incidence of major strokes (5% vs 1.1%; P = .06) and major vascular complications (16.2% vs 1.1%; P < .001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram, the investigators reported in The New England Journal of Medicine.

The Society for Cardiovascular Angiography and Interventions (SCAI) welcomed the advisory panels recommendation and SCAI urged the FDA to approve the device. SCAI stated that if TAVI is approved by the FDA and becomes available for use in the United States, cardiovascular societies will need to work together to: define and develop rigorous training program standards to train physicians on the procedure; provide operator training programs and define program accreditation criteria; establish a nationwide registry to monitor patient complications; and develop standards for multidisciplinary team approaches to providing TAVI to ensure optimal patient outcomes.

SCAI is working with the American College of Cardiology, the Society of Thoracic Surgeons, and the American Association for Thoracic Surgery to develop a policy statement on institutional and operator requirements to define the essential criteria for optimal patient outcomes.

Augusto D. Pichard, MD, who spoke on behalf of SCAI before the FDA review panel commented,“Patients with severe aortic stenosis have very few options and they need treatments like TAVI or they could die from their disease. The PARTNER B trial demonstrates TAVI significantly improves symptoms compared to standard treatments for patients who cannot receive surgery. We urge the FDA to approve this device and allow patients a treatment option that improves quality of life and extends lives.”

SCAI President Christopher J. White, MD, stated, “The FDA panel's recommendation further reinforces the value of TAVI for inoperable patients. For more than 30 years, advances in interventional cardiology have helped improve survival for patients with heart disease. TAVI is an important advancement and as this treatment expands in the United States, it will be important for cardiology societies to work together to establish standards and training to ensure the procedure is used as safely as possible.”