Wednesday, May 29, 2019
TransEnterix, Inc., a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced that it has received Japanese regulatory approval for the Senhance™ Surgical System.
“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,” said Todd M. Pope, president and chief executive officer of TransEnterix. “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.”
The Senhance Surgical System was approved (“Shonin”) by the Ministry of Health, Labor and Welfare (MHLW) for use in laparoscopy for general surgery, gynecology, urology and certain thoracic procedures.
"Approval of the Senhance Surgical System for use in laparoscopic procedures in Japan is a major achievement," said Professor Shigeki Yamaguchi, M.D., Ph.D., Chief of Colorectal Surgery at 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."
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% are private entities. Japanese laparoscopic penetration in surgery is among the highest in the world. The central government has implemented cost containment initiatives in recent years and has approached recent procedure approvals for robotics by establishing reimbursement at the same rate as traditional laparoscopy, which places a high emphasis on procedure cost to influence adoption.
