GALWAY, Ireland– Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the first patient treated with PerQseal® Elite, the latest generation of the company’s fully absorbable large-hole closure system. The first successful implants were completed by Prof. Nicolas Van Mieghem, M.D. Ph.D., at Erasmus University Hospital in Rotterdam, The Netherlands, as part of the company’s ELITE Study—a prospective, multi-center, single-arm clinical study evaluating the safety and efficacy of PerQseal Elite.
PerQseal Elite leverages the legacy PerQseal system’s excellent safety profile and ease of use. The PerQseal Elite system was designed to allow for faster delivery, improved performance in calcium, and treatment of large-hole venous procedures, such as transcatheter mitral valve repair and replacement. PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. It’s placed from inside the vessel, making deployment simpler and more controlled than conventional closure techniques.
“Fast and precise vessel closure is a crucial, final component of large-bore arterial access procedures. Clinicians must act quickly to mitigate the risks of unnecessary and potentially life-threatening bleeding,” said Professor Van Mieghem, principal investigator of the ELITE Study. “The new anchoring system in the PerQseal Elite system holds immense promise for helping with acute performance, and I look forward to continuing the work to evaluate its performance for patients.”
Large-hole arterial access is required for clinicians to perform percutaneous cardiovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysm repair (TEVAR and EVAR), and the use of a cardiac assist device (CAD). The current approach to large-diameter arterial closure is a surgical repair or the use of suture- or collagen-based closure devices. Both can result in major vascular complications, such as vessel distortion at the closure site, which may lead to stenosis, thrombus formation or abrupt closure.
“We’re looking forward to gathering data about the latest generation of the PerQseal system as we continue to innovate and add to our product pipeline,” said Andrew Glass, Chief Executive Officer of Vivasure Medical. “We’re grateful to Professor Van Mieghem for his support in conducting the ELITE Study as we continue making progress toward our goal to enable safe and effective advanced structural and percutaneous cardiovascular therapies.”
The ELITE Study will enroll up to 120 patients in up to 12 European investigational sites. Completion of the study is expected in 2024. The company continues to enroll patients for its Investigational Device Exemption (IDE) clinical study for PerQseal and PerQseal+ in the United States.
