Edwards Lifesciences Corp. in Irvine received Food and Drug Administration clearance for a mitral valve-in-valve replacement procedure using its Sapien 3—“the first transcatheter heart valve approved in the U.S. for the treatment of both aortic and mitral patients,” according to the regulatory agency.
The valve was first approved by the FDA nearly two years ago for patients with severe aortic stenosis—the narrowing of the aortic valve opening that restricts the amount of blood flow through the valve—and often necessitating open-heart surgery.
Edwards’ stock recently traded at $118 per share for a $24.8 billion market cap, Orange County’s most valuable public company. It makes valve implants used in structural heart disease, as well as critical care and surgical monitoring devices.
“The latest FDA approval of the [heart valve] for aortic and mitral valve-in-valve procedure in high-risk patients is significant because patients who would not do well with a subsequent open-heart surgery now have the option to have their heart valve replaced via minimally-invasive transcatheter procedure,” said Larry Wood, corporate vice president of transcatheter heart valves. He didn’t site a dollar valve for the potential market for the new application of the Sapien 3.
Small Group
A valve-in-valve procedure, unlike a transcatheter valve replacement procedure that replaces a person’s diseased valve with an implant, inserts a new valve into a valve that was previously placed surgically via open heart surgery.
Patients needing valve-in-valve surgery are those whose surgical valves are no longer functioning properly due to age or individual anatomy.
Edwards estimates the group of patients suffering from severe symptomatic aortic stenosis is about 650,000 in the U.S., and 2.5 million for those suffering from moderate to severe mitral regurgitation—a backflow of blood caused by failure of the heart’s mitral valve to close tightly.
A company spokesperson said those needing mitral valve-in-valve replacement is “a small group of patients … [but] the indication is meaningful for [them] who, without it, would not have other options.”
Edwards received its first valve-in-valve approval in 2015 for the previous-generation valve Sapien XT, but only for the aortic valve.
The Transcatheter heart valve therapy group netted $539.2 million in sales in the first quarter, up about 46% over 2016.
