Vivasure Medical announced today that it received FDA investigational device exemption (IDE) to advance a clinical study of its PerQseal device.
Additionally, Galway, Ireland-based Vivasure announced a €30 million ($32.2 million) investment from Haemonetics. It marks part of the company’s Series D financing, for which the initial $23 million tranche closed in May 2022. The agreement includes an option for Haemonetics to acquire Vivasure.
Vivasure Medical develops a portfolio of fully absorbable, patch-based, large-bore percutaneous vessel closure devices. Uses for the devices include transcatheter endovascular and cardiovascular procedures.About the Vivasure Patch pivotal study
Vivasure’s Patch clinical study evaluates the safety and effectiveness of the Vivasure PerQseal closure device system. The multi-center, single-arm, pivotal study will enroll up to 188 patients across the U.S. and Europe. Vivasure intends to use clinical results to su…