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TransEnterix Receives FDA 510(k) Clearance for 3mm Diameter Instruments

Posted on October 11, 2018 by Medtech[y] Staff


TransEnterix, Inc. ($TRXC) announced today that the they received FDA 510(k) clearance for 3 millimeter diameter instruments, as well as additional 5 millimeter Senhance System instruments.

“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,” said Todd M. Pope, TransEnterix CEO. “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.”

The clearance of the 3 millimeter diameter instruments will allow the Senhance to be used for microlaparoscopic surgeries, enabling surgeons to operate through tiny incisions considered virtually scarless for patients.

“Utilizing 3 millimeter micro instruments on a robotic system represents a new advancement in reducing the invasiveness of many surgeries,” said Dr. Steven D. McCarus, MD, FACOG, Chief of Gynecologic Surgery at 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.”

What is the Senhance Surgical Robotic System?


TransEnterix continues to execute on all of their 2018 priorities. As we've previously written, the the next two quarters will give investors a true understanding of how the market is receiving the Senhance.