Lydus Medical Vesseal
Lydus Medical’s Vesseal device [Image courtesy of Lydus Medical]

Lydus Medical announced it received FDA 510(k) clearance for its Vesseal microvascular anastomosis suture deployment system.

Ra’anana, Israel-based Lydus Medical designed Vesseal for standardized omni-vessel anastomoses for simple, fast, safe and effective procedures.

Anastomosis is a complicated step of microvascular surgery. It is essential for the success of surgical interventions, according to the company. The procedure is required in breast reconstruction, head and neck reconstruction, surgical lymphedema treatment and vascular access for hemodialysis.

Vesseal mimics the skill set and dexterity needed to deliver patient care in microsurgical anastomoses. It provides surgeons with simple accurate, dependable and consistent results through the symmetrical placement of eight micro-sutures at the anastomosis site, according to the compay.

“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,” CEO Jessica Weiss said in a news release. “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.”

Vesseal will be available for purchase in the U.S. this month through select distributing partners.