Vivasure Launches Large Bore Closure Device in Europe

The Galway, Ireland-based company is now aimed at gaining FDA approval, but Teleflex is looking to enter the U.S. market and Abbott Laboratories has leading share in the space.

Typically, transcatheter endovascular procedures require large bore femoral artery access. Vivasure Medical has come up with PerQseal, a device that can be used to close these large bore arterial punctures and return the artery to its natural state.

“PerQseal is a patch-based implant,” Gerard Brett, co-founder and CEO of Vivasure, told MD+DI. “It’s a patch that seals [and heals] from the inside. What we do is deliver a very thin membrane patch system into the vessel bringing that patch back to the puncture hole.”

He added, “if you’ve ever repaired a bicycle inner tube puncture you would typically put a patch on the outside of the inner tube and then reassemble it. Imagine if you could put that patch on the inside of the inner tube and how effective it could be, because what it does is it allows you to take advantage of the pressure inside the tube. We take advantage of the blood pressure that’s inside the vessel.”

The Galway Ireland-based company recently launched the technology in Europe and has plans to eventually come to the U.S., Japan and then Asia.

“For us the next major target is the U.S., Brett said. “We’re working toward achieving our IDE study approval and enrollment in 2019.”

The secret sauce in the technology is the device’s material.

“We have texturized the surface of the patch that comes up against the hole in the vessel,” he said. “We’ve texturized it in such a way that it traps platelets of the bloodstream when its initially put into the bloodstream. So, when those platelets come back up and are brought into the puncture hole, normally at that puncture hole you have exposed collagen straps. Once platelets get exposed to collagen they get activated. Once they start activating, they begin aggregating. Then what it actually begins to do is form a physical bond with the implant to the puncture site. We’re effectively taking advantage of the natural biology of the patient.”

Vivasure’s main competitor on the market is Abbott Laboratories’ Perclose Proglide Suture Mediated Closure System. It differs significantly for PerQseal because it is designed to close smaller holes. Brett noted there was a work around for the device so that it could close larger structures.

 

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