Medtronic gets U.S., EU nods for GPS-style surgical device

Wednesday, September 13, 2017

Source: Fierce Biotech

Medtronic has received regulatory clearances on both sides of the Atlantic for a surgical navigation device. The StealthStation ENT device uses electromagnetic tracking technology to show surgeons the locations of their instruments during procedures.

The ear, nose and throat (ENT) surgical device is built around an electromagnetic emitter. This flat emitter is placed under the patient’s head to create an electromagnetic field around the ENT area. Surgeons can pull up their patient’s exam and view 3D structures on a 27-inch, high-resolution touchscreen monitor. During the procedure, these preoperative images are matched to the positioning of the patient. 

Medtronic has received 510(k) clearance from the U.S. FDA and a CE mark from officials in the European Union for the device, positioning it to start marketing the product in both territories. The medtech giant has already persuaded some surgeons of the merits of the computer-aided approach. 

“The intraoperative use of computer-aided surgery is very helpful to assist the surgeon in clarifying complex anatomy during sinus and skull base surgery,” Joseph Raviv, M.D., director of endoscopic sinus and skull base surgery at NorthShore University HealthSystem in Chicago, said in a statement. “It provides an added level of assurance and may allow for a more thorough sinus procedure.”

Medtronic has previously applied the same underlying technology to other procedures in which precision is of particular importance, such as those affecting the spine and neurological surgery. 

Benefits specific to the ENT system include its use of software and hardware to create simulations of the sinus cavities. This virtual endoscopy provides surgeons with images of a part of the ENT system that traditional endoscopes cannot access. Surgeons can use the simulation to run through procedures before the surgery itself starts.

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