Medtronic Receives Regulatory Approval for Surgical Navigation Device

According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons performing procedures within the ear, nose, and throat (ENT) anatomy.

Medtronic explains that the StealthStation™ ENT works by generating an electromagnetic field within the ENT anatomy during surgery and allows surgeons to track the locations of instruments during procedures, much like a GPS system used for cars. The surgeons can view 3-D structures on a 27-inch, high-resolution touch-screen monitor. Medtronic already markets a similar system, the StealthStation™ S8, for use in neurosurgery and spine procedures.

The press release reports that StealthStation™ ENT system provides surgeons with enhanced visualization during procedures and also includes several software and hardware innovations such as Virtual Endoscopy. Virtual Endoscopy gives surgeons a simulated view of a patient’s sinus cavities that have previously been unavailable using traditional endoscopy. Thus, Medtronic explains, a surgeon can load a Virtual Endoscopy with a patient’s pre-operative data and practice that patient’s surgery prior to setting foot in the operating room.

The StealthStation™ ENT system should enhance patient outcomes and provide a valuable tool to surgeons. Dr. Joseph Raviv, director of endoscopic sinus and skull base surgery at NorthShore University HealthSystem commented:

"The intraoperative use of computer-aided surgery is very helpful to assist the surgeon in clarifying complex anatomy during sinus and skull base surgery . . . . It provides an added level of assurance and may allow for a more thorough sinus procedure."