Vivasure Medical announced today that the first patient received treatment with its PerQseal Elite large-hole closure system.
Galway, Ireland-based Vivasure designed the latest-generation PerQseal Elite for percutaneous vessel closure. It leverages the legacy platform’s safety profile and ease of use while allowing for faster delivery. The new system also improves performance in calcium and the treatment of large-hole venous procedures. That includes transcatheter mitral valve repair and replacement.
According to a news release, PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. Placement occurs from inside the vessel, making deployment simpler and more controlled than conventional closure techniques.
Large-hole access is required for percutaneous cardiovascular procedures, including transcatheter aortic valve repair (TAVR). Other relevant procedures include thoracic and abdominal endovascular aneurysm repair (TEVAR and EVAR) and the use of a cardiac assist devices (CAD). Current treatment methods include surgical repair or the use of suture- or collagen-based closure devices.
Vivasure says these methods can result in major vascular complications, though.
“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, CEO 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.”
More about the first procedures with the Vivasure technology
Dr. Nicolas Van Mieghem performed the first successful implants at Erasmus University Hospital in Rotterdam, The Netherlands. The procedures took place as part of Vivasure’s ELITE study.
ELITE, a prospective, multi-center, single-arm clinical study evaluates the safety and efficacy of PerQseal Elite.
Vivasure expects the trial to enroll up to 120 patients across up to 12 European investigational sites. It anticipates the study to complete in 2024 while it continues enrolling patients for its U.S. FDA IDE study of PerQseal and PerQseal+.
“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 Van Mieghem, the 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.”
