Vivasure Medical Limited — a developer of advanced polymer implants and delivery systems for cardiology, interventional radiology, and vascular surgery — recently announced it had been granted an Investigational Device Exemption (IDE) by FDA to initiate its PATCH clinical study evaluating the PerQseal Closure Device System.

PerQseal is a sutureless, fully absorbable synthetic implant for large-bore vessel punctures. It can be placed from the inside of the vessel and is intended to make large-diameter arterial closure deployment simpler and more controlled. PerQseal is suitable for arteriotomies up to 24F and requires no pre-procedural steps, has automatic loading, and a dedicated 0.035” compatible introducer. With no sutures, collagen, or metal, the patch becomes fully absorbed within 180 days and its abluminal surface matrix promotes adherence to the vessel and healing. Large hole arterial access is required to perform numerous percutaneous cardiovascular procedures such as transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysm repair (TEVAR and EVAR, respectively), and use of a cardiac assist device.

Currently, approaches for closure of this kind include surgical repair or the use of suture- or collagen-based closure devices, which can result in vascular complications like vessel distortion at the closure site, which may lead to stenosis, thrombus formation, or abrupt closure.

The pivotal, multi-center, single-arm study will enroll up to 188 patients across the United States and Europe to examine the safety and effectiveness of PerQseal. Vivasure intends to use the study results to support an FDA pre-market approval submission as well as multinational commercial launch of the device.

In addition to the IDE announcement, it was also reported that the company received €30 million as part of its Series D financing from Haemonetics Corporation, the initial tranche of which closed in May 2022. The strategic investment by Haemonetics includes an option to acquire Vivasure upon completion of certain milestones. Notably large hole arterial closure represents a high growth global market opportunity currently estimated at over $300 million annually, with potential double-digit growth.

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