Medtronic has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its NIM Vital next-generation intraoperative nerve monitoring system.
The NIM Vital system has been designed to help physicians detect, confirm, and monitor nerve function to minimise the risk of nerve damage during head and neck surgery.
By using advanced technology, the NIM Vital system offers complete intraoperative nerve condition data that helps to implement surgical strategy, as well as increase operative efficiency and precision.
The NIM Vital system offers real-time feedback on nerve function during intermittent or continuous monitoring, thereby enabling surgeons to adjust course as required.
Medtronic already secured CE mark approval for the NIM Vital system to distribute outside the US.
Medtronic restorative therapies group’s ENT business general manager and vice president Vince Racano said: “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.
“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.”
Medtronic acquires Ai Biomed to expand its ENT portfolio
Medtronic has also expanded its ENT portfolio with the recent acquisition of Ai Biomed, which produces a PTeye parathyroid detection system.
The PTeye system, which is claimed to be the only probe-based technology of its kind, will help the physician to identify the parathyroid tissue during thyroid surgery.
Medtronic stated that the purchase of Ai Biomed is the seventh in a series of tuck-in acquisitions that it made in this calendar year.
Recently, Medtronic secured FDA approval for its Abre venous self-expanding stent system for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction or otherwise called deep venous obstruction.
