Business Wire10.05.21
Vivasure Medical, a company pioneering fully absorbable technology for percutaneous vessel closure, has announced its development program for PerQseal Blue, the company’s new investigational product. PerQseal Blue is designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such transcatheter mitral valve repair or replacement (TMVR) and transcatheter tricuspid valve repair or replacement (TTVR). The PerQseal Blue technology is based on PerQseal, the company’s vascular closure device approved in Europe for use in femoral arteries.
The PerQseal Blue development program was first initiated in 2020 and is funded in part by a 2.5 million euros grant awarded by the European Innovation Council Accelerator (EIC). The EIC was part of the European Commission’s Horizon 2020 program and supports innovative entrepreneurs, small companies and scientists planning to expand internationally. Vivasure Medical was one of only 36 companies to receive a grant award from the EIC, which reviewed 1,852 applications from EU-based companies. Horizon 2020 is the largest EU research and innovation program, with nearly 80 billion euros of funding available over seven years.
“As transcatheter procedures for mitral and tricuspid valve treatment become increasingly common, there is a growing need for new venous closure options. These minimally invasive procedures require much larger punctures which often result in vascular complications,” said Dr. Azeem Latib, M.D., section head of Interventional Cardiology and Medical Director of Structural Heart Interventions at Montefiore Medical Center in New York. “Based on my experience using PerQseal for large-bore arteries in percutaneous endovascular procedures, I am optimistic for the potential of PerQseal Blue to provide a simple and safe option for venous closure that does not leave behind any sutures, metal implants, or collagen.”
Currently, there are no sutureless options for venous closure following TMVR or TTVR procedures. PerQseal Blue has the potential to be the first sutureless, fully absorbable synthetic implant for large-bore venous closure following these catheter-based procedures. Leveraging Vivasure Medical’s PerQseal technology, PerQseal Blue consists of an intravascular patch designed to seal the vessel from the inside, returning the vein to its natural state.
“We’re thrilled to introduce PerQseal Blue to our product development portfolio as a potential new option specifically for large-bore venous closure following percutaneous cardiovascular procedures,” said Andrew Glass, CEO of Vivasure Medical. “We plan to advance our venous program to the clinical stage in 2022 with the initiation of a study to evaluate and optimize PerQseal Blue.”
PerQseal is currently available to physicians in Europe for use in novel transcatheter endovascular procedures that require large-bore arterial vessel access, including TAVR, thoracic endovascular aneurysm repair (TEVAR) and endovascular abdominal aneurysm repair (EVAR). Frontier V, a European multicenter study, was recently initiated to evaluate Vivasure Medical’s next-generation PerQseal+ device with an enhanced bioabsorbable patch designed to address more complex patient anatomies. PerQseal+ is intended to provide physicians with an even more robust solution for managing challenges and bleeding complications associated with large-bore arterial closure.
Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. The PerQseal Blue development program has received funding from the European Union’s Horizon 2020 research and innovation program.
The PerQseal Blue development program was first initiated in 2020 and is funded in part by a 2.5 million euros grant awarded by the European Innovation Council Accelerator (EIC). The EIC was part of the European Commission’s Horizon 2020 program and supports innovative entrepreneurs, small companies and scientists planning to expand internationally. Vivasure Medical was one of only 36 companies to receive a grant award from the EIC, which reviewed 1,852 applications from EU-based companies. Horizon 2020 is the largest EU research and innovation program, with nearly 80 billion euros of funding available over seven years.
“As transcatheter procedures for mitral and tricuspid valve treatment become increasingly common, there is a growing need for new venous closure options. These minimally invasive procedures require much larger punctures which often result in vascular complications,” said Dr. Azeem Latib, M.D., section head of Interventional Cardiology and Medical Director of Structural Heart Interventions at Montefiore Medical Center in New York. “Based on my experience using PerQseal for large-bore arteries in percutaneous endovascular procedures, I am optimistic for the potential of PerQseal Blue to provide a simple and safe option for venous closure that does not leave behind any sutures, metal implants, or collagen.”
Currently, there are no sutureless options for venous closure following TMVR or TTVR procedures. PerQseal Blue has the potential to be the first sutureless, fully absorbable synthetic implant for large-bore venous closure following these catheter-based procedures. Leveraging Vivasure Medical’s PerQseal technology, PerQseal Blue consists of an intravascular patch designed to seal the vessel from the inside, returning the vein to its natural state.
“We’re thrilled to introduce PerQseal Blue to our product development portfolio as a potential new option specifically for large-bore venous closure following percutaneous cardiovascular procedures,” said Andrew Glass, CEO of Vivasure Medical. “We plan to advance our venous program to the clinical stage in 2022 with the initiation of a study to evaluate and optimize PerQseal Blue.”
PerQseal is currently available to physicians in Europe for use in novel transcatheter endovascular procedures that require large-bore arterial vessel access, including TAVR, thoracic endovascular aneurysm repair (TEVAR) and endovascular abdominal aneurysm repair (EVAR). Frontier V, a European multicenter study, was recently initiated to evaluate Vivasure Medical’s next-generation PerQseal+ device with an enhanced bioabsorbable patch designed to address more complex patient anatomies. PerQseal+ is intended to provide physicians with an even more robust solution for managing challenges and bleeding complications associated with large-bore arterial closure.
Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. The PerQseal Blue development program has received funding from the European Union’s Horizon 2020 research and innovation program.
