MMI receives FDA clearance, completes first U.S. clinical use of robotic microsurgical dissection instruments

Italy-based medical robotics company Medical Microinstruments (MMI), which is dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, announced it received U.S. Food and Drug Administration’s (FDA) 510(k) clearance for its NanoWrist Scissors and Forceps, indicated for soft tissue dissection.

The company said that the clearance enables delicate tissue manipulation and dissection in robotic microsurgery, expanding the role of the company’s Symani Surgical System beyond anastomosis to include additional critical steps in complex surgery.

First use occurred at a Tampa hospital

The first U.S. clinical use of the cleared instruments was completed at Tampa General Hospital (TGH), home to an established microsurgical robotics program. The company said that the lymphovenous bypass (LVB) procedure, which utilizes the full capabilities of Symani, represents the world’s first fully robotic-assisted microsurgical operation from initial incision to skin closure.

Dr. Nicholas J. Panetta, MD, FACS, Chair of the Department of Plastic Surgery at the University of South Florida Morsani College of Medicine and Chief of the Plastic Surgery Institute at TGH, specializes in microvascular reconstructive plastic surgery.

For the surgery, MMI said that the Symani and the NanoWrist Instrument Portfolio were utilized to complete a specialized microsurgical technique that redirects tiny lymphatic vessels to nearby veins, helping relieve swelling by restoring fluid drainage. He accessed the surgical site and prepared the lymphatic vessels and veins using the NanoWrist Scissors and Forceps for delicate tissue handling, precise dissection and vessel preparation.

The bypass was then performed with the NanoWrist SuperMicro Needle Holder Suture Cut and SuperMicro Dilator. MMI said that all instruments in the portfolio offer seven degrees of freedom, delivering precise robotic capabilities and the full benefits of Symani’s motion scaling and tremor reduction features.

"Robotics will define the future of microsurgery, especially in lymphedema work where sub-millimeter precision is essential,” said Dr. Panetta. “I have been able to push the limits of microsurgery to treat some of the smallest and most delicate vessels, and the impact Symani is having on our patients has been transformative. With robotic-enabled dissection, I was able to complete a fully robotic LVB, from incision to closure, with unmatched precision, control and improved ergonomics. These tools are unlocking capabilities that extend beyond the limits of the human hand to support the best possible outcomes for patients.”

MMI said its dissection instruments are the world’s first and smallest fully wristed robotic instruments designed specifically for dissection in open microsurgery. The NanoWrist Scissors and Forceps are designed to preserve tissue integrity and reduce vessel trauma to help improve patient outcomes. This level of precision and control is especially critical in complex procedures such as surgical lymphatic repair, perforator-to-perforator reconstruction, and cancer-related head & neck reconstruction.

"As we continue to evolve Symani, the first dissection instruments are a critical step in that mission,” said Mark Toland, CEO of MMI. “The addition of these capabilities to our platform is game-changing in supermicrosurgical procedures where extreme precision for the smallest vessels is essential. We will continue to develop technologies that advance the future of microsurgery with Symani and transform microsurgical care and countless lives worldwide.”