FDA Grants IDE Approval to Vivasure Study of Vascular Closure System

The FDA has granted Investigational Device Exemption (IDE) to Vivasure Medical’s study to evaluate the effectiveness and safety of the company’s PerQseal closure system for use in vascular surgeries.

The sutureless and absorbable synthetic implant is designed for procedures that require large hole arterial access, such as transcatheter aortic valve replacement, thoracic and abdominal endovascular aneurysm repair and the use of cardiac assist devices.

The implant offers an alternative to surgical repair or the use of suture- or collagen-based devices for large-diameter arterial closure, the company said.

The IDE-cleared study results will be used to support the company’s premarket approval submission.