Medtronic’s ENT Portfolio Grows with FDA Clearance of NIM Vital and Acquisition of Ai Biomed

Medtronic plc, has received U.S. FDA 510(k) clearance of the NIM Vital™ nerve monitoring system, which enables physicians to identify, confirm, and monitor nerve function to help reduce the risk of nerve damage during head and neck surgery.

Background

Even with detailed knowledge of anatomy and surgical skill, motor nerves can sometimes be difficult to identify during surgery due to disease, a previous operation, or normal anatomical variations. 

The NIM Vital system uses proprietary technology to provide detailed intraoperative nerve condition data that informs surgical strategy. It claims to increasing operative efficiency and precision, and help protect patients’ quality of life.

The system enables surgeons to locate and identify nerves, monitor and control manipulation effects, and confirm nerve integrity prior to completing the surgery. Proprietary technology provides real-time feedback on nerve function during intermittent or continuous monitoring so surgeons can adjust course as needed. A large touch-screen and streamlined interface provide an intuitive, guided workflow with enhanced visualization. Now available in the United States, the NIM Vital system is also CE marked for distribution outside the U.S.

Further enhancing its ENT portfolio, Medtronic has also announced the recent acquisition of privately-held Ai Biomed Corp., maker of the PTeye™ parathyroid detection system. PTeye system is uniquely designed to help confirm parathyroid tissue identified visually by the physician during thyroid surgery.

Clinician comments

“Protecting critical structures during surgery has evolved to an extensive system that brings crucial information to the surgeon’s hands and eyes,” said Gregory Randolph, M.D., professor of Otolaryngology, Claire and John Bertucci endowed chair in Thyroid Surgical Oncology at Harvard Medical School and surgeon at Massachusetts Eye and Ear Infirmary. “There are things we can’t do with our eyes and our hands. Both the NIM Vital and PTeye systems empower surgeons to improve their procedures, and Medtronic continues to provide these types of important operative solutions.”

Company comments

“The addition of these two technologies builds on our 20-year legacy of providing innovative solutions that assist surgeons during critical head and neck procedures,” said Vince Racano, vice president and general manager of the ENT business, which is part of the Restorative Therapies Group at Medtronic. “By offering these complementary technologies – the NIM Vital system to protect crucial nerves and the PTeye system to help confirm parathyroid tissue identified visually by the surgeon – we’re helping physicians address two of the most common challenges during these procedures.”

Source: PR Newswire

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