As it aims to broaden the reach of its replacement heart valves among younger patients, Edwards Lifesciences has put forward new clinical data showing its bioprosthetics can maintain their function over the long term.
The company highlighted a study spanning eight years that compared the performance of surgical aortic valves made with its proprietary Resilia tissue to those without, showing reduced rates of deterioration and the need for fewer follow-up operations. The results were presented at the annual meeting of the Heart Valve Society, being held in Cairo.
In development for more than two decades, the Resilia technology treats bovine pericardial tissue to make it more resistant to calcification, where built-up mineral deposits can become a major cause of implant failure over time. It also allows for the device to last longer in dry storage.
The material is employed in a range of Edwards’ surgical and transcatheter valves, including versions of the Inspiris, Mitris and Sapien 3 Ultra. The company estimates that more than 450,000 patients worldwide have received Resilia-equipped implants through open surgery or TAVR procedures.
“With patients of all ages living longer and demanding higher quality of life, the importance of lifetime management has never been greater,” Larry Wood, group president of Edwards’ TAVR and surgical structural heart business, said in a statement.
In the study, which included 947 participants, 99.3% of patients in the Resilia arm saw no structural valve deterioration, versus 90.5% in the non-Resilia group. Similarly, 99.2% did not have to undergo subsequent reintervention surgeries, compared to 93.9%.
The Resilia tissue will also be employed in Edwards’ upcoming Sapien X4 transcatheter valve replacement, which is currently being tested in clinical studies of patients with severely calcified and narrowed aortic heart valves.
Last fall, at the TCT conference in Washington, D.C., a randomized study from Edwards of patients with aortic stenosis showed that receiving a TAVR implant before cardiac symptoms take a turn toward severe led to significant reductions in a combination measure of death rates, strokes and unplanned cardiovascular hospitalizations after two years.