Lydus Medical received FDA clearance 510(k) for Vesseal, a microvascular anastomosis suture deployment system, for standardized omni-vessel anastomoses, enabling simple, fast, safe, and effective procedures.

An anastomosis is one of the most complicated steps of microvascular surgery and fundamental to the success of these demanding surgical interventions. Varied clinical fields require micro-vascular anastomosis. These include breast reconstruction; head and neck reconstruction; surgical lymphedema treatment LVA; and vascular access for hemodialysis.

Until now, microvascular anastomoses have been performed manually. Manual micro-anastomoses are time and labor intensive, require a long learning curve, a unique skill set and great surgical dexterity. The Vesseal is designed to mimic the skill set and dexterity needed to deliver quality patient care in microsurgical anastomoses. It provides, simple, accurate, dependable and consistent results through symmetrical placement of eight micro-sutures at the anastomosis site.

“FDA clearance of the Vesseal is a significant milestone both for innovation in microvascular anastomoses, and for Lydus Medical. It is common knowledge that there are large clinical unmet needs around microvascular anastomosis,” says Jessica Weiss, CEO Lydus Medical. “Clinicians who used the Vesseal stated that it shows a significant advantage over the manual anastomosis and provides more consistency in the procedure. We believe that the Vesseal will support enhanced outcomes in microsurgical procedures, as well as improved patient care.”

Simplifying microvascular anastomoses, the Vesseal will be available for purchase in the in U.S. January 2023 via select distributing partners, to support surgeons and patients alike.