Edwards Lifesciences to release Sapien 3 Ultra Resilia valve in US after gaining FDA approval

Edwards Lifesciences (NYSE: EW) will release its next-generation Sapien 3 Ultra Resilia transcatheter heart valve in the US, after gaining approval from the United States Food and Drug Administration (FDA).

The California-based company’s latest Sapien 3 Ultra Resilia transcatheter heart valve is paired with its breakthrough RESILIA tissue technology.

Edwards corporate vice president of transcatheter aortic valve replacement Larry Wood said obtaining approval caps off the ongoing efforts by the company.

“The Sapien 3 Ultra Resilia valve builds on Edwards’ 40 years of leadership in tissue technology by combining advancements in tissue science with the industry-leading Sapien 3 Ultra valve to offer the only dry storage transcatheter heart valve on the US market today,” he said.

“The SAPIEN 3 Ultra Resilia valve is a prime example of Edwards’ continued focus on innovating to meet the current and future needs of patients to help them live longer, healthier and more productive lives.”

The Resilia material includes bovine pericardial tissue treated with anti-calcification technology, as the backbone of its new class of valves, including using it in the development of the Sapien X4 valve, which is currently undergoing clinical trials.

Enhanced calcium blocking priorities

The company said the tissue offers enhanced calcium blocking properties and dry tissue packaging conditions which make it easier to use.

“The Resilia tissue’s anti-calcification technology addresses one of the primary causes of reintervention following heart valve replacement,” Mr Wood said.

Resilia tissue has also shown to demonstrate freedom from structural valve deterioration at five years – extending the durability of the Sapien 3 Ultra valve.

Resilia’s preservation treatment has been developed for 10 years to further the life span of a valve, compared to traditional bioprosthetics.

It also allowed the implant to last longer in dry storage and simpler handling methods prior to procedures were other components developed in the treatment.

US launch

Edwards has confirmed it expects Sapien 3 Ultra Resilia will become available in the US through a limited release in the fourth quarter of 2022, which was included as part of the company’s 2022 financial expectations.

The company confirmed Sapien 3 Ultra Resilia is the only dry storage transcatheter heart valve on market today in the US.

Edwards’ strategy is developing patient-focused innovations for structural heart disease and critical care monitoring, aiming to improve and enhance lives through collaboration with clinicians and stakeholders.