TransEnterix Announces FDA 510(k) Submission for 3mm Senhance Instruments

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June 8, 2018

TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery announced the Company filed an FDA 510(k) submission for additional Senhance System instruments including 3-millimeter diameter instruments.

TransEnterix notes the clearance of these instruments would allow the Senhance to be used for microlaparoscopic surgeries, allowing surgeons to make tiny incisions that are deemed virtually scarless for patients.

“TransEnterix is the first company to seek FDA clearance for robotically-driven 3 millimeter instruments for abdominal surgery in the U.S.,” said Todd M. Pope, TransEnterix CEO. “We believe Senhance robotic assistance can enable surgeons to expand their use of virtually scarless surgery in more patients, and expands the value that robotics can bring over traditional manual approaches.”

“Microlaparoscopy is the current frontier in the process of reducing invasiveness, pain, scarring, and opioid use post-surgery,” said Dr. Steven D. McCarus, MD, FACOG, Chief of Gynecologic Surgery at Florida Hospital Celebration Health. “With Senhance, robotic micro laparoscopic surgery is a reality, bringing precision, control, and sensitive force feedback to the use of these tiny surgical instruments. Surgeons have not had the ability to use such small instruments with a robotic surgical platform before, and this offers patients an attractive, virtually scarless approach to many surgeries.”

In the U.S., Senhance is cleared for laparoscopic colorectal, gynecologic, inguinal hernia, and cholecystectomy surgery, enabling Senhance to be used in over 3 million procedures per year, including some of the most common abdominal surgeries in general surgery and gynecology.



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