FDA clears energy tools for TransEnterix robotic surgery system

Dive Brief:

TransEnterix, which is working to expand its foothold in the robotic surgery market, said it has gained FDA 510(k) clearance for a set of advanced energy instruments that can be used with the company's Senhance system.
The ultrasonic devices are designed to deliver controlled energy to ligate and divide tissue while minimizing thermal damage to surrounding structures, the company said Tuesday.
The addition of the Senhance Ultrasonic System gives surgeons tools that are critical for use in a range of laparoscopic procedures, broadening the capabilities and potential applications for the company’s robot-assisted surgical platform, TransEnterix CEO Todd Pope said in a press release.

Dive Insight:

TransEnterix is gaining momentum in the robotic surgery market. It has been just over a year since its Senhance platform became the first robot-assisted abdominal surgery system to win FDA approval since Intuitive Surgical established the market with the da Vinci system in 2000.

In October, FDA cleared a set of smaller-sized instruments for use with the Senhance robot. The 3- and 5-millimeter instruments allow surgeons to operate through smaller incisions, minimizing scarring for patients.

Earlier this month, TransEnterix said it sold a total of 15 Senhance robotic surgery systems in 2018, which Pope called a "significant year." The Research Triangle Park, North Carolina-based company also said it completed the acquisition of Israel-based MST Technologies, giving it advanced visualization, scene recognition, artificial intelligence and data analytics. And it announced the launch of the ultrasonic instrument set in CE Mark countries.

In the United States, Senhance is cleared for laparoscopic colorectal, gynecological, inguinal hernia and gallbladder removal surgeries. TransEnterix distinguishes itself as the first robotic surgical system to offer reusable instruments, keeping procedure costs in line with traditional laparoscopic surgeries.

In becoming the second robotic system for abdominal surgeries to be cleared by FDA, TransEnterix is ahead of a number of prospective competitors expected to enter the field, from Google-parent Alphabet's life sciences arm Verily, to established medtech players such as Medtronic and Johnson & Johnson and small startups.