Dive Brief:

• Medtronic said Monday it received the CE mark in Europe for its Stealth AXiS surgical navigation system in ear, nose and throat procedures, broadening the platform’s reach among surgeons and hospitals.
• Recently CE marked for spine and cranial surgeries, the system is now also positioned to support a range of ENT procedures, from minimally invasive sinus and skull base surgeries to sinus balloon procedures.
• Stealth AXiS improves on earlier-generation surgical systems, integrating planning, navigation and robotics in one platform. Medtronic expects the system to be an important growth driver for its cranial and spinal technologies unit, CFO Thierry Piéton said last week on an earnings call.

Dive Insight:

Medtronic is the global market leader in ENT technologies, according to the announcement. In the U.S., the Food and Drug Administration cleared Stealth AXiS in spine surgery in February and followed with cranial and ENT indications a month later.

Stealth AXiS provides faster system responsiveness and improved anatomical visualization compared to previous-generation platforms, Medtronic said.

The surgical navigation system integrates with Medtronic’s AiBLE ecosystem that combines artificial intelligence, data and services to enable personalized pre-operative planning for patients as well as post-operative analysis.

Piéton, on the earnings call, said the early commercial launch of the Stealth AXiS system is progressing well, with positive feedback from physicians and sales that are “off to a very strong start.”

Stealth AxiS promotes the adoption of robotics in spine surgery and creates efficiencies in the operating room that allow more physicians to use it without disrupting workflow, Piéton said.

“All of this makes our installed base stickier over time,” said the CFO. “With robotics penetration still in the high single digits, we see significant runway ahead.”