Vivasure Medical Receives FDA IDE Approval for Pivotal Study of PerQseal Closure Device

March 13, 2023—Vivasure Medical Limited, an Ireland-based company focused on fully absorbable technology for percutaneous vessel closure, announced that the FDA has granted an investigational device exemption to advance the company’s PATCH clinical study.

The multicenter, single-arm PATCH pivotal study will evaluate the safety and effectiveness of the Vivasure PerQseal closure device system. The study will enroll up to 188 patients across the United States and Europe and is expected to be completed by year-end 2023.

The company intends to use the clinical study results to support an FDA premarket approval submission as well as the multinational commercial launch of the PerQseal system for large-hole vessel closure.

According to the company, PerQseal is designed to be a sutureless, fully absorbable synthetic implant for large-bore vessel punctures. Its low-profile patch can be placed from inside the vessel and is intended to make deployment simpler and more controlled than conventional closure techniques. Clinical studies to date have shown a low complication rate and high technical success, noted Vivasure.

The company also announced that Haemonetics Corporation invested €30 million in the company as part of its Series D financing, the initial tranche of which closed in May 2022. The strategic investment by Haemonetics includes an option to acquire Vivasure Medical on completion of certain milestones.

Haemonetics is a global health care company headquartered in Boston, Massachusetts. The company is a provider of medical products and solutions for interventional cardiology and electrophysiology procedures, the surgical suite, hospital transfusion services, and blood and plasma component collection.

Vivasure Medical’s CEO, Andrew Glass, commented in the company’s press release, “We are excited to be moving forward with this multicenter pivotal study, which we expect will affirm the safety and effectiveness of PerQseal for large-hole arterial closure. Moreover, we are delighted to now be partnered with Haemonetics, which has quickly established itself as a market leader in advanced vessel closure.”

Mr. Glass continued, “We strongly believe in the potential of our fully absorbable patch-based approach to large-hole closure, and these steps mark important progress toward fulfilling our mission of enabling safe and effective advanced structural and percutaneous cardiovascular therapies.”

Stew Strong, President, Global Hospital at Haemonetics, stated, “Vascular closure is a key focus of Haemonetics’ growth strategy, and we are excited about the long-term potential of Vivasure’s innovative technology to advance large-hole percutaneous procedures.”