The company plans to use the findings of the trial to support a pre-market application to the FDA and the global commercial launch of the PerQseal system for big-hole vessel closure
FDA has granted IDE to Vivasure to initiate US pivotal study. (Credit: Arek Socha from Pixabay)
Vivasure Medical has received an Investigational Device Exemption (IDE) from US Food and Drug Administration (FDA) to advance its PATCH Clinical Study of the Vivasure PerQseal Closure Device System.
PATCH Clinical Study is a multi-centre, single-arm, pivotal study that intends to evaluate the safety and effectiveness of the PerQseal Closure Device System.
PerQseal is claimed as the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures.
Expected to be completed by the end of this year, Vivasure’s Patch clinical study will enrol up to 188 patients across the US and Europe.
The Ireland-based firm plans to use the findings of the trial to support a pre-market application to the FDA. It also aims to launch the PerQseal system globally for large-hole vessel closure.
Vivasure Medical CEO Andrew Glass said: “We are excited to be moving forward with this multi-centre pivotal study which we expect will affirm the safety and effectiveness of PerQseal for large hole arterial closure.
“Moreover, we are delighted to now be partnered with Haemonetics, which has quickly established itself as a market leader in advanced vessel closure.
“We strongly believe in the potential of our fully absorbable patch-based approach to large hole closure, and these steps mark important progress toward fulfilling our mission of enabling safe and effective advanced structural and percutaneous cardiovascular therapies.”
Additionally, the company raised €30m from Haemonetics as part of its previously announced Series D financing.
Haemonetics’ strategic investment agreement includes the option to buy Vivasure Medical upon completion of certain milestones.
The company has designed the PerQseal with a low-profile patch that can be placed from inside the vessel. Vivasure said that this aims to make deployment simpler and more controlled than conventional closure techniques.
The Irish firm claimed that various clinical studies to date showed a low complication rate and high technical success.