January 9, 2023

Lydus Medical’s Vesseal Device for Microvascular Anastomosis Cleared by FDA

January 9, 2023—Lydus Medical, based in Ra’anana, Israel, announced that the company’s Vesseal has received 510(k) clearance from the FDA. Lydus, which was founded in 2017, is a portfolio company of Sanara Ventures, a joint venture of Teva and Philips.

According to Lydus Medical, Vesseal is a microvascular anastomosis suture deployment system for standardized omnivessel anastomoses. It is designed to enable simple, fast, safe, and effective procedures. Beginning in January 2023, the Vesseal will be commercially available in the United States via select distributing partners.

Vesseal is designed for symmetrical placement of eight microsutures at the anastomosis site. The device mimics the skill set and dexterity needed for microsurgical anastomoses and provides simple, accurate, dependable, and consistent results, stated Lydus Medical.

The company noted that traditional manual performance of microvascular anastomoses is time and labor intensive and requires a long learning curve, a unique skill set, and great surgical dexterity. Clinical fields using microvascular anastomosis include breast reconstruction; head and neck reconstruction; surgical lymphedema treatment—lymphaticovenous anastomosis; and vascular access for hemodialysis.

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January 9, 2023

Lydus Medical’s Vesseal Device for Microvascular Anastomosis Cleared by FDA

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