Japan regulatory agency clears Intuitive’s single-port robotic surgical system

SUNNYVALE, Calif., Sept. 30, 2022 (GLOBE NEWSWIRE) -- Intuitive (Nasdaq:ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) cleared the da Vinci SP^® surgical system for use in general surgeries, thoracic surgeries (excluding cardiac procedures and intercostal approaches), urologic surgeries, gynecological surgeries, and trans-oral head and neck surgeries. Intuitive Japan will begin the product launch of SP in the near future.

MHLW first cleared Intuitive’s multi-port system in 2009, and since then, Japan has added coverage for 29 robotic-assisted procedure types by public insurance, which will include procedures performed on SP.

The da Vinci SP system provides surgeons with robotic-assisted technology designed for deep and narrow access to tissue in the body. The ability to enter the body through a single, small incision helps enable a minimally invasive experience for complex procedures.

“Japanese surgeons have developed high expectations from Intuitive robotic systems, since the MHLW cleared our first multiport system in 2009,” said Gary Guthart, Intuitive CEO. “We are delighted to receive clearance for the single-port robotic system, which we believe will provide Japan’s surgeons with more opportunities to provide minimally invasive care.”

The da Vinci SP system includes three, multi-jointed, wristed instruments and a fully wristed 3D HD camera. The instruments and the camera all emerge through a single cannula and are properly triangulated around the target anatomy at the distal tip to avoid external instrument collisions that can occur in narrow surgical workspaces. The system enables flexible port placement and excellent internal and external range of motion (e.g., 360-degrees of anatomical access) through the single SP arm. Surgeons control the fully articulating instruments and the camera on the da Vinci SP system from a surgeon console.

“The da Vinci SP is part of Intuitive’s fourth generation of products, and along with the da Vinci X and Xi multiport systems, allow us to offer our customers more options. We also hope that the introduction of the da Vinci SP will contribute to making minimally invasive robot-assisted surgeries more accessible to patients,” said Kazuhiro Takizawa, president of Intuitive Japan.

In addition to Japan, the da Vinci SP system can be used in Korea for urologic surgery, general laparoscopic surgery, gynecologic laparoscopic surgery, general thoracoscopic surgery, and otolaryngologic surgery performed via an oral approach. In the U.S., the Food and Drug Administration has cleared the da Vinci SP for urology and transoral otolaryngology procedures.

About Intuitive
Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale, California, is a global leader in minimally invasive care and the pioneer of robotic surgery. Our technologies include the da Vinci surgical system and the Ion endoluminal system. By uniting advanced systems, progressive learning, and value-enhancing services, we help physicians and their teams optimize care delivery to support the best outcomes possible. At Intuitive, we envision a future of care that is less invasive and profoundly better, where diseases are identified early and treated quickly, so patients can get back to what matters most.

Contact:
Peper Long
202 997 7373