Vivasure Medical First Patient in Study of Next-Gen PerQseal+ Device

Vivasure Medical, a company pioneering novel fully absorbable technology for percutaneous vessel closure, has enrolled the first patient in the Frontier V study, a European multicenter study evaluating PerQseal+, the next generation of the company’s PerQseal device.
 
The company’s PerQseal device is the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. PerQseal is currently available to physicians in Europe for use in novel transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair (EVAR), that require large-bore vessel access. The enhanced PerQseal+ device is intended to provide physicians with an even more robust solution for managing challenges and bleeding complications associated with large-bore closure.The patient was enrolled by Dr. Fernando Gatto, head of cardiac catheter labs and senior interventional cardiologist at SHG-Kliniken Völklingen in Völklingen, Germany, and investigator of the study. The study will evaluate the company’s next-generation PerQseal+ device with an enhanced bioabsorbable patch designed to address more complex patient anatomies.
 
“PerQseal+ is a promising potential advancement for providing simple and sutureless closure for large-bore vascular procedures,” said Dr. Gatto. “Rapid and secure vessel closure has remained a high priority for interventional cardiologists as more and more structural heart procedures transition to fully percutaneous approaches. Vascular complications remain a significant challenge for TAVR, and these complications are associated with more adverse events and increased costs. I am honored to participate in this study because PerQseal+ may help elevate the standard of care for our patients.”
 
“The current generation of the PerQseal device has proven to be a reliable and valuable addition to our tool chest for large bore closure,” said Dr. Christian Frerker, head of structural heart disease and senior cardiologist at the University of Schleswig-Holstein in Lübeck, Germany, and principal investigator of the Frontier V study. “This study will provide us with a better understanding of PerQseal+’s potential benefits in our growing complex patient population.”
 
“Enrolling the first patient in the Frontier V study is an exciting milestone in Vivasure’s mission to ensure success for percutaneous cardiovascular therapies,” said Andrew Glass, CEO of Vivasure. “The original PerQseal device has been well-received by clinicians since it became available in Europe because it helps address the complications and risks associated with access-site management for large-bore procedures. The enhanced PerQseal+ device promises to build on that success by enabling even better patient outcomes.”
 
Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. 

The PerQseal is not available for sale in the United States.