TransEnterix (NYSE:TRXC) said yesterday it submitted a 510(k) submission to the FDA seeking clearance for extra instruments for its Senhance robotic surgical platform, including 3 mm diameter instruments.
The Research Triangle Park, N.C.-based company said that the clearance would allow the Senhance to be used in microlaparoscopic surgeries. The platform is currently cleared for laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgeries.
“Microlaparoscopy is the current frontier in the process of reducing invasiveness, pain, scarring and opioid use post-surgery. With Senhance, robotic microlaparoscopic 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,” Dr. Steven McCarus of Florida Hospital Celebration Health said in a prepared statement.
“TransEnterix is the first company to seek FDA clearance for robotically-driven 3 millimeter instruments for abdominal surgery in the U.S.. 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,” CEO Todd Pope said in a press release.
Last month, TransEnterix won expanded indications from the FDA for its Senhance robot-assisted surgery device, which is now cleared for hernia and gallbladder procedures.