Domain Surgical Receives CE Mark Approval for its FMsealer Vessel Sealing Instruments

FMsealers provide surgeons with reliable vessel sealing while minimizing thermal damage to surrounding tissue. With approval, FMsealers are now cleared for sale and clinical use in Europe.

SALT LAKE CITY (May 12, 2016) - Domain Surgical, a leading manufacturer of advanced thermal surgical instruments, announced today that the company has received CE Mark approval for its FMsealer Open Shears and FMsealer Laparoscopic Shears vessel sealing instruments.

FMsealers are multifunctional thermal surgical instruments that use ferromagnetic technology to efficiently seal and divide tissue with minimal lateral thermal spread in both open and laparoscopic surgical procedures. FMsealers can be used in any open or laparoscopic surgical procedure where ligation of vessels, including lymph vessels, is desired. FMsealers are used to seal and ligate vessels up to 7mm in diameter, and tissue bundles as large as will fit into the jaws of the instrument.

"We are pleased to announce CE Mark approval for the FMsealer instruments," said David McNally, President and CEO of Domain Surgical. "FMsealer Open Shears have already been successfully used in open surgery in the United States. Surgeons using the instrument appreciate its ergonomics, speed, and reliability. The FMsealer can be instantly swapped out with our FMwand precision dissection instrument at any time during a surgery, providing unequaled precision in dissection and vessel sealing; while utilizing just a single source of advanced surgical energy. With CE Mark approval, we now look forward to bringing the clinical benefits of ferromagnetic vessel sealing to our customers in Europe."

CE Mark approval for FMsealer instruments was based on extensive laboratory and pre-clinical studies with leading surgeons. The results of these studies demonstrated that FMsealers offer consistent and reliable vessel sealing, while imparting less thermal damage to surrounding tissues than leading competitive instruments. FMsealers also offer quicker sealing and dividing cycles than leading competitive instruments.

The FMsealer is a component of Domain Surgical's FMX Ferromagnetic Surgical System. The FMX System uses ferromagnetic technology to precisely cut, coagulate, and seal tissue and vessels; with a fraction of tissue injury compared to other surgical technologies, and without passing electrical current through the patient. The FMX system is used in numerous surgical sub-specialties including cardiothoracic, head & neck, neurosurgery, surgical oncology, and more.

About Domain Surgical, Inc.
Domain Surgical, Inc. is a privately held company based in Salt Lake City, Utah. The company has commercialized a surgical platform for precise cutting, coagulation, and sealing of tissue and vessels. Domain Surgical's patented technology produces surface-only tissue effects without passing electrical energy through the patient, and is designed to provide unparalleled safety and reliability in the most critical surgical applications. For more information, please visit domainsurgical.com.

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