Intuitive Surgical Gets FDA Clearance for da Vinci Sp

The FDA has granted Intuitive Surgical 510(k) clearance for the da Vinci Sp surgical system, which helps physicians control EndoWrist Sp instruments during urologic surgical procedures that are appropriate for a single-port approach.

The da Vinci Sp patient-side cart is designed to expand Intuitive’s single-incision product offerings. It delivers an articulating 3D HD camera, along with three fully articulating instruments — which Intuitive claims have two more degrees of freedom than the single-site instruments — through just one 25 mm cannula.

A company spokeswoman told Device Daily Bulletin that U.S. commercialization of the system won’t come until late next year, as the Sunnyvale, Calif., robotic surgery system maker is first making its technology fully compatible with the new da Vinci Xi system, released earlier this month.

The advantage of this, she said, is that surgeons can switch between patient carts for multi-port and single-port surgeries, rather than buying a whole new system. The company also plans to seek new indications for Sp in the near future, she added.

Intuitive has hit some road bumps with its surgical robots. A 2013 FDA survey of physicians who used da Vinci products found the results were mostly positive, but that training was often inadequate. Some physicians reported stuck, locked or cracked surgical arms and failure of the system’s memory functions. — Lena Freund

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