Edwards Lifesciences has received the CE mark for its Inspiris Resilia aortic valve, which is the first in a new class of resilient heart valves. A press release reports that the valve incorporates the advanced Resilia tissue and leverages features of the Perimount Magna Ease valve. Furthermore, the Inspiris Resilia valve incorporates the proprietary VFit technology—designed for potential future valve-in-valve procedures.
According to the press release, a key innovation of the Inspiris valve is the Resilia tissue—a new, first-of-its-kind tissue platform that has been in development for more than a decade and builds on Edwards’ 40 years of leadership in tissue technology. Resilia tissue uses Edwards’ integrity preservation technology, which preserves the tissue and provides improved anticalcification properties and sustained haemodynamic performance. Additionally, the valve is stored dry and ready to use.
The CE mark for the new valve was supported by the COMMENCE pivotal trial, which is a global FDA premarket approval study. One-year results of this study were presented during the 2016 late-breaking sessions of the American Association for Thoracic Surgery’s (AATS) annual meeting. The results of 673 patients showed no cases of structural valve deterioration, valve thrombosis or non-structural valve dysfunction. In addition, a series of preclinical studies have shown Resilia tissue to offer key benefits, such as significantly reduced calcification and sustained haemodynamics compared to a current treatment option.
More data from the COMMENCE trial will be presented during a late-breaking session at the European Association for Cardio-Thoracic Surgery’s (EACTS) annual meeting. Three-year results of the Resilia tissue EU feasibility study will also be presented at the meeting.
Vinayak (Vinnie) Bapat (Guy’s and St Thomas’ Hospital, London, UK) says: “Heart valve patients are living longer and want to maintain their active lifestyles. The Inspiris valve provides surgeons and their patients with an advanced treatment option that represents an ideal foundation for the future treatment of heart valve patients,.”