Vivasure Medical has announced the European launch of the PerQseal closure device for large-bore transcatheter procedures.
Novel transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair (EVAR), require large-bore femoral artery access.
Closure of these large-bore access sites is challenging and has been associated with significant vascular and bleeding complications.
PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore arterial punctures. The PerQseal technology consists of an intravascular patch that seals the vessel from the inside, returning the artery to its natural state.
Frankfurt’s CardioVascular Center professor Horst Sievert said: “Closing the artery has been a concern since we started using transcatheter techniques for valve implantation.
“The PerQseal device is a very innovative solution for closing large holes, and we are enthusiastic to make it part of our armamentarium.”
Vivasure Medical co-founder and CEO Gerard Brett said: “We’re excited that the PerQseal device is now widely available to European physicians, providing a safe and simple option for the closure of large puncture holes that leaves behind no sutures, metal implants, or collagen.
“This commercial launch is a key milestone for Vivasure as we journey to enable better patient outcomes in fully percutaneous large-bore endovascular procedures.”
UK’s New Cross Hospital Wolverhampton heart and lung centre Dr Saib Khogali said: “In my first clinical experience with PerQseal, I found the device intuitive and well controlled, which helped me quickly learn how to use the technology safely and successfully.
“I believe the PerQseal has the potential to be an important large-hole closure device in many TAVR and EVAR patients.”
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.
Source: Company Press Release