Edwards Lifesciences ($EW) expects to launch a new bioprosthetic valve next year. Management has already described its Inspiris as a "game changer" that could be useful for a younger patient population. Inspiris incorporates novel bovine tissue technology, known as Resilia, that's intended to remove the major source of calcification that plagues other tissue technologies and to enable dry storage. Inspiris is surgically implanted--but in a few years Resilia could be incorporated into a transcatheter aortic valve replacement (TAVR).
The technology is furthest along in aortic use--but is also in the clinic for mitral and pulmonary valve replacement. Inspiris Resilia is expected to be approved in Europe late this year and early next year in the U.S. The mitral study and the pulmonary study, which is in congenital child and young adult patients, are currently enrolling patients.
"Inspiris, … I believe, is a game changer," said Edwards corporate VP of surgical heart valve therapy Bernard Zovighian at a December investor meeting. "Basically, when you're a patient, when you are about to receive a valve, you ask yourself how long it is going to last. And with the TAVR in a broader adoption, we are going to target younger and younger patients. So this question is going to be critical for us to answer and for the surgeon to answer."
The company noted that about half of target patients needing this combination are under 60 years old and that they currently are confined mainly to mechanical valves.
Edwards reported data on a valve featuring Resilia at the American Association for Thoracic Surgery's meeting. In a 673-patient pivotal trial, the valve showed no cases of structural valve deterioration, valve thrombosis or nonstructural valve dysfunction at one year.
"The early clinical results with the new valve with Resilia tissue in this multicenter, international FDA trial are encouraging and set a high benchmark for surgical aortic valve replacement," said Dr. John Puskas, chair of cardiothoracic surgery at Mount Sinai Beth Israel and director of surgical coronary revascularization at Mount Sinai Health System, in a statement. He is the national principal investigator of the study.
He continued, "The Resilia tissue has the potential to create a new class of surgical tissue valves that pre-clinical studies have shown to offer key benefits, such as significantly reduced calcification and sustained hemodynamics."
- here is the data announcement