April 10, 2024

Newly FDA-approved microsurgical system holds promise for training, new treatments

Editor's Note

The US Food & Drug Administration (FDA) has granted De Novo authorization for marketing MMI North America Inc.’s Symani Surgical System, according to the agency’s April 9 roundup. The system employs a motion scaling function to scale down surgeons movements for procedures requiring small instruments and/or microscopes, such as surgery on small blood vessels and lymphatic ducts.

According to a report from the manufacturer, The FDA De Novo authorization makes the Symani Surgical System the only commercially available platform in the U.S. for reconstructive microsurgery. It is designed “to open the field of microsurgery to new surgeons by quickly developing their skills, as well as to empower skilled microsurgeons to confidently expand into supermicrosurgery, creating a novel category of treatments that the human hand cannot perform without robotic assistance.”

The system reportedly owes much of its capability to the NanoWrist, a proprietary design that enables surgeons to replicate the natural movement of the human hand at a micro scale, potentially easing and speeding training.

Noting that fewer than 600 surgeons worldwide perform supermicrosurgery today, the manufacturer's report claims the system can be effective for a range of open surgeries, including post-mastectomy breast cancer reconstruction, extremity reconstruction using free tissue transfer, and lymphatic system repair. “Within the next five years, this expanded portfolio of addressable open surgical procedures is expected to exceed the number of eligible laparoscopic, or minimally invasive, procedures that leverage robotic assistance,” says Dr. L. Scott Levin, co-CMO of MMI.

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