Vivasure Medical announced today that the first patient was treated in a U.S. early feasibility study of its next-generation PerQseal+ device.
Galway, Ireland-based Vivasure’s study will evaluate PerQseal+ in percutaneous transcatheter aortic valve replacement (TAVR) procedures. The first patient was treated by Dr. Robert Pyo at Stony Brook University Hospital in Stony Brook, New York.
The company designed PerQseal+ to provide physicians with an option for managing challenges and bleeding complications associated with large-bore arterial vessel closure, according to a news release.
Vivasure’s first-generation PerQseal device, a sutureless and fully absorbable synthetic implant for large-bore arterial vessel punctures, is available in Europe. That version has an intravascular patch that seals the vessel from the inside, while the PerQseal+ has an enhanced bioabsorbable patch designed to address more complex patient anatomies. The next-generation PerQseal+ is under clinical evaluation in Europe, Vivasure said.
The company also has PerQseal Blue under development. The company has designed PerQseal Blue for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such as transcatheter mitral valve repair or replacement (TMVR) and transcatheter tricuspid valve repair or replacement (TTVR)
“Despite years of advancement, vascular complications remain the most common event for TAVR procedures, so further innovation is needed. Enrolling the first patient in this study is an important step forward in bringing a new, cutting-edge option for large-bore vessel closure to physicians in the U.S.,” Vivasure CEO Andrew Glass said in the release. “We are looking to initiate a pivotal trial in the U.S. later this year to further evaluate our PerQseal technology for safety and efficacy in percutaneous large-bore endovascular procedures, which will support our submission to the FDA.”