MMI (Medical Microinstruments Inc.) has been awarded De Novo classification from the U.S. Food and Drug Administration (FDA) for its Symani robotic surgical system for soft tissue manipulation to perform microsurgery.
 
The highly specialized technique involves reconnecting tiny vessels to restore blood flow or redirect fluid during reconstruction or repair.
 
This FDA nod, according to MMI, makes Symani the only commercially available platform in the U.S. for reconstructive microsurgery. The tech is expected to open the field of microsurgery to new surgeons by developing their skills, as well as empowering skilled microsurgeons to expand into supermicrosurgery. This creates a novel treatment category that the human hand can’t perform without robotic assistance.
 
Specific techniques include reconnecting blood and lymphatic vessels during open surgeries. Supermicrosurgery involves reconstruction or repair of vessels typically less than 1 mm in diameter. Fewer than 600 surgeons worldwide perform supermicrosurgery today.
 
The Symani system features the world’s smallest surgical robotic wrist, called NanoWrist. Its design enables replication of the human hand’s natural movements at the micro scale. The articulated wrist has seven degrees of freedom to match the human wrist, tremor filtration, and motion scaling as well.
 
Symani offers advanced solutions for open surgeries include post-mastectomy breast cancer reconstruction, extremity reconstruction using free tissue transfer, and lymphatic system repair. Surgeons have leveraged Symani in almost 1,000 clinical cases in the EU and in thousands of preclinical cases around the world.
 
“The U.S. is facing a potentially dire shortage of physicians, and that shortage acutely impacts specialized fields of medicine, such as microsurgery,” said Mark Toland, CEO of MMI. “With the authorization from the FDA, our technology will expand its reach to pioneering hospitals in the U.S. It will help those hospitals grow their open surgical programs, expand the number of physicians who can perform these highly complicated procedures, and increase patient access to the most advanced techniques for surgeries in complex disease states, such as lymphedema. Our system will continue to provoke surgeons to challenge their definitions of ‘treatable’ and ‘untreatable’ and empower them to solve cases that have historically been too difficult to treat.”
 
“By making open surgery less invasive and more precise, we can treat more conditions and offer robotic-assisted surgical options to patients that simply do not exist today,” added Dr. L. Scott Levin, co-CMO of MMI. “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. The authorization from the FDA helps to solve a critical unmet need and will help surgeons perform a new category of complex open surgeries enabled by transformative technology.”