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TransEnterix Earns FDA Clearance For The Senhance’s 3mm Instruments

October 16, 2018 By Daniel Seeger

TransEnterix announced last week FDA clearance for 3mm diameter instruments associated with the Senhance Surgical System. The new clearance brings the robotically assisted surgical system into the field of microlaparoscopic procedures.

“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,” Todd M. Pope, CEO of TransEnterix, said in a statement. “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.”

Additional 5mm instruments for the Senhance also received FDA clearance.

The Senhance entered the market one year ago, becoming the first new abdominal surgical robotics device offered in U.S. in nearly two decades. Since then, TransEnterix has reported steady sales and has been moving aggressively to expand the capabilities of its flagship product.

The Senhance received clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy surgeries earlier this year, and TransEnterix recently initiated a $32.8 million deal to purchase Medical Surgery Technologies, a surgical imaging software company based in Israel. The Senhance also recently achieved its CE mark approval, allowing the device to enter the European Union market.

Pope emphasizes the positive disruption TransEnterix and the Senhance bring to the healthcare field.

“One of the challenges, specifically for surgeons, is that minimally invasive surgery has remained fairly static for the past few decades,” Pope recently told Media Planet. “Millions of surgical procedures are performed laparoscopically each year in the United States with manual tools that limit surgeons’ capability, comfort and control. The current state can be improved for both patients and surgeons. The challenge is to leverage technology that can meaningfully enhance surgeon skills and clinical outcomes while working within today’s value-based health care. At TransEnterix, we have commercialized a new digital interface between the surgeon and the patient to bring the benefits of robotics to more patients and more procedures.”

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