Sam Brusco, Associate Editor01.10.23
Lydus Medical has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Vesseal microvascular anastomosis suture deployment system for standardized omni-vessel anastomoses.
Anastomosis is one of the most complicated steps in microvascular surgery and is fundamental to success. Microvascular anastomosis is required in breast reconstruction, head/neck reconstruction, surgical lymphedema treatment LVA, and vascular access for hemodialysis.
Until this device, microvascular anastomoses were performed manually and the process is time and labor intensive, requiring a long learning curve, unique skill set, and great surgical dexterity. Vesseal aims to mimic the skill set and dexterity needed.
Simple, accurate, dependable, and consistent results are enabled via 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," Jessica Weiss, CEO of Lydus Medical told the press. "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 became available for purchase in the U.S. as of this month.
Anastomosis is one of the most complicated steps in microvascular surgery and is fundamental to success. Microvascular anastomosis is required in breast reconstruction, head/neck reconstruction, surgical lymphedema treatment LVA, and vascular access for hemodialysis.
Until this device, microvascular anastomoses were performed manually and the process is time and labor intensive, requiring a long learning curve, unique skill set, and great surgical dexterity. Vesseal aims to mimic the skill set and dexterity needed.
Simple, accurate, dependable, and consistent results are enabled via 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," Jessica Weiss, CEO of Lydus Medical told the press. "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 became available for purchase in the U.S. as of this month.