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.

 

Mark Rubinshtein
Mark Rubinshtein's practice focuses on patent litigation and prosecution for clients in the chemical and pharmaceuticals industries. Dr. Rubinshtein earned his J.D. at University San Diego School of Law. Prior to law school, Dr. Rubinshtein obtained a B.A in Chemistry and M.S. in chemical engineering from Columbia University and completed his PhD in organic chemistry in 2011 at UC San Diego. His graduate work focused on developing targeted small molecular therapeutics for Alzheimer's disease and on devising synthetic methods for the preparation of side-chain functionalized biodegradable and biocompatible polymers.
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