TransEnterix submits FDA clearance bid for Senhance ultrasonic instrumentation

TransEnterix (NYSE:TRXC) said today it filed an FDA 510(k) submission for its Senhance Ultrasonic instrument system, designed to operate with its Senhance robotic platform.

The Research Triangle Park, N.C.-based company said that the approval would allow the system to utilize ultrasonic devices designed to deliver controlled energy to ligate and divide tissue and minimize thermal injury to the surrounding structures.

“Advanced energy devices, such as the one now developed for Senhance, represent the most common tools that surgeons utilize when performing challenging tissue dissections. Adding such capability to a digital laparoscopic platform will further enable wide clinical use,” Dr. Guy Orangio of LSU Health New Orleans said in a prepared statement.

“Advanced energy devices are an important tool within laparoscopic surgery because of their applicability within a wide range of procedures. Once approved, we believe the addition of the Senhance Ultrasonic will be a useful tool for surgeons and help drive broader penetration of Senhance and help advance digital laparoscopy in the U.S.,” CEO Todd Pope said in a prepared statement.

The application comes only a handful of months after the company filed a seperate 510(k) submission with the FDA seeking clearance for extra instruments for its Senhance robotic surgical platform, including 3 mm diameter instruments.

The platform is currently cleared for laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgeries.

Last month, TransEnterix saw shares fall after the robotic surgical platform developer posted second quarter earnings that beat expectations on Wall Street, but showed growing losses.

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