Domain Surgical Receives FDA 510(k) Clearance for its FMsealer Open Shears for Vessel Sealing and Dividing
SALT LAKE CITY (August 5, 2014) – 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 Open Shears, a vessel sealing and dividing device that is indicated for use in open surgical procedures.
The FMsealer Open Shears uses pure thermal energy to precisely seal and divide lymphatics and tissue bundles, as well as vessels (both arteries and veins) up to 7mm in diameter in open procedures, without passing any electrical current through the patient. With non-stick performance, the FMsealer provides safe, fast, and reliable sealing and dividing of tissue and vessels, and minimized thermal spread in a variety of tissue types. The FMsealer features dual activation modes; a ‘Min’ mode for low power, secure vessel sealing, 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.
The FMsealer Open Shears has received FDA indications for use in general and gynecological surgery and other open surgical procedures where ligation of vessels, including lymph vessels, is desired. The FMsealer Open Shears can be used to seal and ligate vessels up to 7mm in diameter and tissue bundles as large as will fit into the jaws of the device.
“Receiving FDA clearance for the FMsealer Open Shears is a significant milestone in the expansion of our award-winning FMX Ferromagnetic Surgical System platform,” said David McNally, President and CEO of Domain Surgical. “Our vision is to provide the surgical staff with a broad array of safer, more ergonomic advanced energy surgical tools that are all powered by the same compact FMX Generator. The FMsealer and our commercially available FMwand dissection devices provide surgeons with best-in-class surgical precision and control of thermal effects, with clinical benefits that are applicable across numerous surgical sub-specialties.”
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.