Medical devices maker TransEnterix has secured 510(k) from the US Food and Drug Administration (FDA) for its 3mm millimeter diameter instruments.
The US regulator has also approved additional 5mm Senhance system instruments of TransEnterix.
The approval of 3mm diameter instruments will enable the use of Senhance in microlaparoscopic surgeries, allowing surgeons to operate via tiny incisions considered virtually scarless for patients.
TransEnterix CEO Todd Pope said: “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.
“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 company is engaged in the commercialization of Senhance surgical system, which has been developed to digitize laparoscopic minimally invasive surgery.
Senhance surgical system will enable robotic precision, haptic feedback, surgeon camera control through eye sensing and improved ergonomics.
The system is currently available in the US, the EU and other selected countries.
Florida Hospital Celebration Health gynecologic surgery chief Dr Steven McCarus said: “Utilizing 3 millimeter micro instruments on a robotic system represents a new advancement in reducing the invasiveness of many surgeries.
“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.”
In September this year, TransEnterix acquired all assets, including technology and intellectual property, of Israel-based MST Medical Surgery Technologies.
MST, which is focused on surgical technology field, developed a software-based image analytics platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.
The firm’s technology and software engine can enhance Senhance platform, enabling to provide better digital laparoscopy for patients, surgeons and operating rooms globally.
TransEnterix will transfer Israeli-based R&D team of MST Medical Surgery Technologies to a newly formed subsidiary, TransEnterix Israel.