Sam Brusco, Associate Editor03.13.23
Vivasure Medical, a company pioneering absorbable percutaneous vessel closure technology, has earned a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) to advance its PATCH clinical study. PATCH is a multi-center, single-arm, pivotal study to evaluate the Vivasure PerQseal closure device system’s safety and effectiveness.
The study will enroll up to 188 patients in the U.S. and Europe. Vivasure aims to use the study results to support FDA premarket approval and multinational commercial launch of PerQseal.
PerQseal is designed as the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. A low profile patch can be placed from inside the vessel and aims to make deployment simpler and more controlled than conventional closure techniques, which can result in major vascular complications.
Haemonetics Corporation has also invested €30 million in the company as well as part of its Series D financing. The strategic investment includes an option to acquire Vivasure on completion of specific milestones.
“We are excited to be moving forward with this multi-center 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,” Andrew Glass, CEO of Vivasure Medical told the press. “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.”
“Vascular closure is a key focus of Haemonetics’ growth strategy, and we are excited about the long-term potential of Vivasure’s innovative technology to advance large hole percutaneous procedures,” said Stew Strong, President, Global Hospital at Haemonetics.
Large hole arterial access is needed to perform percutaneous cardiovascular procedures like transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysn repair (TEVAR and EVAR), and use of a cardiac assist device (CAD).
The study will enroll up to 188 patients in the U.S. and Europe. Vivasure aims to use the study results to support FDA premarket approval and multinational commercial launch of PerQseal.
PerQseal is designed as the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. A low profile patch can be placed from inside the vessel and aims to make deployment simpler and more controlled than conventional closure techniques, which can result in major vascular complications.
Haemonetics Corporation has also invested €30 million in the company as well as part of its Series D financing. The strategic investment includes an option to acquire Vivasure on completion of specific milestones.
“We are excited to be moving forward with this multi-center 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,” Andrew Glass, CEO of Vivasure Medical told the press. “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.”
“Vascular closure is a key focus of Haemonetics’ growth strategy, and we are excited about the long-term potential of Vivasure’s innovative technology to advance large hole percutaneous procedures,” said Stew Strong, President, Global Hospital at Haemonetics.
Large hole arterial access is needed to perform percutaneous cardiovascular procedures like transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysn repair (TEVAR and EVAR), and use of a cardiac assist device (CAD).