TAVI Pendulum Swings Back Edwards Way as Sapien XT Gets FDA Approval

Last week the transcatheter valve pendulum swung towards Medtronic with the news that its CoreValve system had gained FDA approval for high risk patient using transfemoral and alternative access routes. Now it’s back on Edwards Lifesciences side as the company tells us that its own Sapien XT has gained the nod for the same patient group. Sapien XT, as you may recall, has been shown in one German study, to outperform CoreValve when assessed on procedural success.


It’s all happening for these two combatants, the main players in the emergent U.S. transcatheter valve land grab. A matter of weeks after the protagonists buried the hatchet with a financial settlement that leases them both with unfettered market access, it seems the race to that market is well and truly on. Last week Medtronic looked like it had grabbed the initiative with FDA approval for CoreValve bringing its regulatory indications alongside the already approved Edwards Sapien device. Surely the might of Medtronic would see it start to eat into Edwards installed base? Well maybe, or maybe not, as now it transpires that Edwards Lifesciences has gained FDA approval for its Edwards SAPIEN XT transcatheter aortic heart valve for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis. Sapien XT is considered by its maker to represent the next-generation of TAVI devices. It is a lower-profile system, and includes the 29mm valve size for patients with a large native annulus, will allow for the treatment of more patients.

In the recently reported German study, so-called CHOICE, Sapien XT and Medtronic CoreValve were randomised into 241 patients. While the two devices were comparable in terms of bleeding and vascular complications, the balloon expandable Sapien XT heart valve achieved procedural success in 95.9% of cases compared with 77.5% in the CoreValve group. Unlike its balloon-expandable competitor, CoreValve saw a higher rate of residual valve regurgitation, a key determinant of success. Reinforcing that point, Sapien XT cases required a second valve in only 0.8% of cases compared with 5.8% for CoreValve.

Edwards says XT will be made immediately available to patients at leading cardiovascular centers across the nation, along with the NovaFlex+ transfemoral delivery system that can be delivered through a low-profile 16-French expandable sheath (eSheath) and the Ascendra+ transapical and transaortic delivery systems.

Investigator comments

“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,” said 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. Dr. Leon was the co-principal investigator for the PARTNER II Trial, which was Edwards’ second randomized controlled trial of a transcatheter valve and evaluated the SAPIEN XT valve. “The results from the PARTNER II Trial in treating U.S. inoperable patients with the SAPIEN XT valve demonstrated a reduction in complications with the TAVR procedure, and improved patient outcomes over earlier trials.”

Company comments

“Clinicians have demonstrated their confidence in the SAPIEN valves by making them the market-leading transcatheter valves, and this approval provides greater options for U.S. patients who can benefit from the substantial enhancements in this proven platform,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves. “The SAPIEN family of valves has been used in the treatment of more than 70,000 patients globally – with the majority of those patients treated with SAPIEN XT – and we look forward to Heart Teams across America transforming the lives of even more patients with this advanced transcatheter valve.”

Source: Edwards Lifesciences

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