Devices & Diagnostics

Aortic stenosis patients with moderate risk to open-heart surgery can now choose TAVR instead

The Food and Drug Administration expands the indication for Edwards Lifesciences' Sapien 3 valve allowing the transcatheter aortic valve replacement procedure to aortic stenosis patients who have intermediate risk of undergoing open-heart surgery.

FDA approval

Transcatheter aortic valve replacement (TAVR) has been steadily gaining ground as studies have shown its superiority over invasive, open-heart surgery for patients suffering from aortic stenosis.

The cohort of patients who first got access to this minimally invasive technology to replace diseased heart valves were those deemed too sick to undergo open-heart procedures. But as the clinical evidence has grown, companies developing next-generation products began to push for patients that have lower risk for surgery to also have access to TAVR.

One such company is Edwards Lifesciences that announced Thursday that the Food and Drug Administration has expanded the label indication for its Sapien 3 TAVR valve to include patients who have intermediate risk for open-heart procedures.

Sapien3While Medtronic has competing TAVR valves in the U.S., the Sapien 3 valve is the first in the U.S. to obtain this expanded indication, a news release from Edwards noted.

“The Sapien 3 valve has set a new standard for performance and patient outcomes with aortic valve replacement,” said Dr. Vinod Thourani, co-director of Emory Heart and Vascular Center’s Structural Heart and Valve Center and professor of cardiothoracic surgery at Emory University School of Medicine, in a statement. “The clinical outcomes of 1.1 percent mortality and 1 percent disabling stroke at 30 days in this intermediate-risk population treated with the Sapien 3 valve are changing the paradigm of how we treat patients with aortic stenosis.”

The Sapien 3 valve is the most advanced of all the TAVR valves made by the Irvine, California medical device company. Back in June 2015, that valve was approved by the FDA in June 2015 to treat patients with severe, symptomatic aortic stenosis who were deemed to have high-risk for open heart surgery.

If more doctors adopt this therapy for more patients — as is expected given strong clinical trial results of the Sapien 3 — it bodes well for Edwards and the overall TAVR market.

“With the global TAVR market already growing seemingly sustainably faster than expected, more aggressive adoption in intermediate risk patient population could make our 25% 2017 global TAVR growth projection conservative, as well as our 22% 2015-2021 projected compound annual growth rate,” wrote Danielle Antalffy, an analyst with Leerink Partners, a healthcare investment bank, in a research note following Edwards’ announcement.

If and when Edwards can bring down the access point even further down the risk scale, the market may well be broadened further. Already, the Sapien 3 low-risk trial is underway, according to Antalffy, with all trial sites active.

While the battle in the TAVR market, at least in the U.S. is between Medtronic and Edwards, [there are many more players in Europe including Boston Scientific, for instance] other companies are eyeing a low-risk population too.

JenaValve, a California company, with roots in Germany, is also busy developing a new TAVR valve that is supposed to have less complications related to paravalvular leak and the need to implant pacemakers to make it more attractive to younger patients with aortic stenosis.

[Photo Credit: Edwards Lifesciences]

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