FDA Clears Lydus Medical’s Vesseal for Small Artery Surgery

Lydus Medical has gained 510(k) clearance for its Vesseal device, a microvascular suture deployment system for use in the connection of small vessels.

One of the most complicated steps of microvascular surgery, manual micro-anastomoses are time and labor intensive, requiring great surgical dexterity. The Vesseal device is designed to mimic the skill set and dexterity needed for symmetrical placement of micro-sutures at the anastomosis site.

Among the surgeries that require micro-vascular anastomosis are breast reconstruction, head and neck reconstruction, and vascular access for hemodialysis.

Israel-based Lydus Medical said the device will be available in the U.S. starting this month.