Japan approves TransEnterix Senhance system for robot-assisted surgery

Japanese regulators approved TransEnterix‘s Senhance robot-assisted surgery device for several procedures. Japan’s Ministry of Health, Labor & Welfare granted “shonin” approval to Senhance for laparoscopy for general surgery, gynecology, urology and “certain thoracic procedures,” the Research Triangle Park, N.C.-based company said.

“Regulatory approval in Japan is a pivotal milestone for our company, as Japan is second only to the U.S. as the world’s largest surgical robotics market,” president & CEO Todd Pope said in prepared remarks. “Japan’s high penetration of laparoscopic surgery coupled with their rapid adoption of robotics and the intense focus on procedure cost creates a considerable market opportunity for Senhance.”

“Approval of the Senhance Surgical System for use in laparoscopic procedures in Japan is a major achievement,” added Dr. Shigeki Yamaguchi of the Saitama Medical University International Medical Center. “As the first hospital in Japan to obtain and utilize the Senhance surgical system to treat patients, I believe this technology allows surgeons to offer excellent minimally invasive procedures that add precision and visual control while leveraging a familiar laparoscopic approach with minimal additional costs to the health system.”

Earlier this year TransEnterix won 510(k) clearance from the FDA for an ultrasonic instrument set for Senhance for soft tissue ligation and dissection, after winning CE Mark approval in the European Union for Senhance Ultrasound last year. Last November TransEnterix closed the $33 million buyout of surgery planning software maker Medical Surgery Technologies.

Japan is the second-largest medical device market in the world, valued at over $40 billion annually, including over $5 billion in capital equipment spending. There are more than 8,400 hospitals in Japan, of which approximately 80 percent are private entities. Japanese laparoscopic penetration in surgery is among the highest in the world.

Senhance is the only market-cleared competitor for Intuitive Surgical and its da Vinci line of surgical robotics systems, which first won FDA approval in 2000. TransEnterix touts Senhance as the only platform with haptic force feedback, reusable instruments and 3mm instruments.