Vivasure Launches Large Bore Closure Device in Europe
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, â ...
Source: MDDI - November 17, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Vivasure Medical launches PerQseal closure system in the EU
Ireland-based Vivasure Medical said today it launched its PerQseal closure device intended for large-bore transcatheter procedures. The newly launched device is intended for novel transcatheter endovascular procedures including transcatheter aortic valve replacements, thoracic endovascular aneurysm repairs and endovascular abdominal aneurysm repairs, which require large-bore femoral artery access. The system consists of an intravascular patch to seal the vessel from the inside. Vivasure Medical touted the PerQseal as the first sutureless, fully absorbable synthetic implant for large bore arterial punctures. “Clo...
Source: Mass Device - November 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Vivasure Source Type: news

InSeal Medical wins CE Mark for vascular closure device
InSeal Medical said today it won CE Mark approval in the European Union for its InClosure vascular closure device designed to close large bore arterial punctures. The device is implanted percutaneously and requires no pre-procedure or sheath exchange and features a biodegradable membrane which is coupled to the vessel wall by a thin Nitinol frame, the Israel-based company said. “The InClosure VCD significantly simplified large bore puncture closure which is still one of the last major challenges in TAVR. Based on our growing experience, the InClosure VCD allows for a smoother and safer TAVR procedure without pre...
Source: Mass Device - August 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance InSeal Medical Ltd. Source Type: news

FDA approves Vasorum ’ s Celt ACD vascular closure device
Vasorum said today that it won pre-market approval from the FDA for its Celt ACD vascular closure device. The Dublin-based company said the Celt ACD is designed to close punctures to the femoral artery after catheterization, using a biocompatible implant on both the inside and outside of the arterial wall. Vasorum said the PMA approval was based on a 207-patient trial in the U.S. and Europe led by Dr.Shing-Chiu Wong of the NewYork-Presbyterian/Weill Cornell Medical Center. The device has already won CE Mark approval in the European Union, Vasorum said. “With more than 20,000 patient...
Source: Mass Device - July 21, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Vasorum Source Type: news