Domain Surgical Receives FDA 510(k) Clearance for its FMsealer Laparoscopic Shears for Vessel Sealing and Dividing
SALT LAKE CITY (January 5, 2015) – Domain Surgical, a leading developer of advanced thermal surgical technology, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its FMsealer Laparoscopic Shears, a vessel sealing and dividing device that is indicated for use in open and laparoscopic surgical procedures.
The FMsealer Laparoscopic Shears uses pure thermal energy to precisely seal and divide tissue bundles, as well as vessels – including lymph vessels, arteries and veins – in general and gynecologic procedures. It can be used to seal and divide vessels up to 7mm in diameter, and tissue bundles as large as will fit in the jaws of the device. The FMsealer provides safe, fast, and reliable sealing and dividing of tissue and vessels with minimal thermal spread, without passing any electrical current through the patient. The FMsealer features dual activation modes; a ‘Min’ mode for low power, secure sealing of large vessels, and a ‘Max’ mode for quick sealing and cutting of thin membranes and large tissue bundles. An active cooling system, integral to the FMsealer, provides lower temperature device operation compared to other commercially available vessel sealers.
“Receiving FDA clearance for the FMsealer Laparoscopic Shears is an important step in the planned evolution of our award-winning FMX Ferromagnetic Surgical System platform,” said David McNally, President and CEO of Domain Surgical. “The laparoscopic shears allow us to now bring the unique clinical benefits of our patented ferromagnetic surgical technology to minimally invasive laparoscopic surgical procedures. The FMsealer Laparoscopic Shears, along with our recently FDA cleared FMsealer Open Shears and the commercially available FMwand dissection devices, provide surgeons across numerous surgical sub-specialties with a broad array of safe advanced energy surgical tools that are all powered by the same FMX Generator.”
In support of its FDA medical device submission, Domain Surgical successfully conducted extensive laboratory and pre-clinical studies with leading surgeons.
About OmniGuide Holdings, Inc.
OmniGuide Holdings is a patient safety-focused medical technology innovator, providing a portfolio of advanced energy surgical tools to benefit clinicians and their patients. The company’s technologies deliver energy in a precise and electrically silent manner, resulting in the preservation of healthy tissue.
OmniGuide Surgical, a leader in flexible fiber CO2 laser technology, offers a range of products designed to enhance surgical accuracy, access and control for minimally invasive surgery, laparoscopy and robotic-assisted surgery.
Domain Surgical, by OmniGuide, provides a patented ferromagnetic technology designed to provide safety and predictability in select surgical procedures that require cutting, coagulating and sealing tissue.