Edwards Lifesciences Corp. received Food and Drug Administration approval for a new aortic heart valve, Inspiris Resilia. The valve expands on the device maker’s capability in tissue heart valves used in surgical valve replacement, featuring “first of its kind” tissue, and structural innovations, according to the company.
“The Inspiris valve creates a new class of surgical valves … to advance the treatment of patients with heart valve disease,” said Bernard Zovighian, corporate vice president of surgical heart valve therapy.
The valve uses Resilia tissue, a more durable tissue that reduces calcification—the accumulation of calcium deposits can cause narrowing of the opening of the aortic valve, greatly reducing blood flow. The more resilient tissue could benefit those with active lifestyles, according to physicians who participated in the clinical study.
The valve is also designed for potential future valve-in-valve procedures with its expandable frame VFit technology.
Patients needing a valve-in-valve surgery are those whose surgical valves are no longer functioning properly due to age or individual anatomy, the company said. A valve-in-valve procedure inserts a new valve into a valve that was previously placed via open-heart surgery.
Approval for Inspiris Resilia was based on data from a two-year 689-patient trial. The valve was approved in Europe last year.
Edwards has surgical and transcatheter valve businesses that make up 55% and 23%, respectively, of the Irvine device maker’s net sales last year. The company also makes critical care and patient-monitoring products.
It is the largest publicly traded company headquartered in Orange County, with nearly $25 billion in market cap.
The company noted sales of its surgical platform were slightly below expectations last year, partially due to the impact of its transcatheter valves in U.S. and Europe. But Edwards executives anticipate strong growth this year from regions that have slower adoption rates of transcatheter valves, according to information from its 2016 investor conference. The trans-catheter approach is less invasive than open-heart surgery, requiring only a small incision in the femoral artery.
Zovighian pointed out that with the launch of the more durable Inspiris valve, Edwards’ surgical platform is better positioned to compete with mechanical heart valves. He says the company will start a full U.S. launch of Inspiris Resilia early next year.
The general recommendation is for patients younger than 60 to 65 to use mechanical valves because they provide longer durability. But while mechanical valves are more durable than tissue valves, they require patients to take blood-thinning medication to prevent blood clot formation, which could increase the risk of severe bleeding, which increases as patients age.
Inspiris valve is currently Edwards only one using Resilia tissue, but Zovighian does not discount the possibility of expanding the application of the technology more broadly across the Edwards valve portfolio, including transcatheter heart valves.
“We continually look for ways to improve all of our devices, and we will evaluate the best approach to applying this new tissue platform as we study it further,” he said.
