TransEnterix wins FDA nod for 3mm instrument set

TransEnterix (NYSE:TRXC) said today that it won 510(k) clearance from the FDA for a 3mm-diameter instrument set for its Senhance robot-assisted surgery device.

The federal safety watchdog also OK’d additional 5mm-diameter instruments, the Research Triangle Park, N.C.-based company said. The 3mm instrument open up micro-laparoscopic “virtually scarless” procedures for Senhance, according to TransEnterix.

“The ability to perform microlaparoscopic procedures using 3-millimeter instruments represents an unparalleled shift in the world of robotic surgery and a capability exclusive to the Senhance system,” CEO Todd Pope said in prepared remarks. “The addition of 3-millimeter instruments will allow many high volume surgeries to be performed with smaller incisions, which supports our mission of advancing minimally invasive surgical capabilities within digital laparoscopy.”

“Utilizing 3 millimeter micro instruments on a robotic system represents a new advancement in reducing the invasiveness of many surgeries,” added Dr. Steven McCarus of Florida Hospital Celebration Health. “Patients find such small incisions to be virtually scarless and cosmetically desirable. Surgeons may find that using such tiny instruments with the precision and control of a digital interface makes microlaparoscopy a preferred option to treat more conditions.”

Earlier this month TransEnterix won CE Mark approval in the European Union for the Senhance Ultrasonic instrument system; a bid for U.S. clearance is under way. In September the company put up $33 million for Medical Surgery Technologies and its surgical planning software.

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