DUBLIN, Oct. 29, 2020 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced it has received U.S. Food and Drug Administration (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.1 The NIM Vital system uses proprietary
technology to provide detailed intraoperative nerve condition data
that informs surgical strategy,2 increases operative
efficiency and precision,3 and helps protect patients'
quality of life.4
The company also announced further enhancement of its ENT
portfolio with the recent acquisition of privately-held Ai Biomed
Corp., maker of the PTeye™ parathyroid detection system. The only
probe-based technology of its kind,5 the PTeye system is
designed to help confirm parathyroid tissue identified visually by
the physician during thyroid surgery.
"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."
"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."
About the NIM Vital Intraoperative Nerve Monitoring
System
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.6,7 Clinical evidence demonstrates the
benefits of intraoperative nerve monitoring for nerve preservation
and as a risk-minimizing tool.2,3,8
The NIM Vital 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.9 Now
available in the United States,
the NIM Vital system is also CE marked for distribution outside the
U.S.
About the Ai Biomed Corp. Acquisition and the PTeye
System
The acquisition of Ai Biomed Corp. expands upon
intraoperative technology like the NIM Vital platform and supports
the Medtronic goal of using innovative technologies to improve head
and neck surgery. The PTeye system helps confirm parathyroid tissue
identified visually by the physician, which is a crucial step in
thyroid surgery.
The most common type of thyroid surgery involves partial or full
removal of the thyroid glands. During thyroid procedures, it is
important for surgeons to identify and preserve parathyroid tissue
so that it is not inadvertently removed, which may result in
hypocalcemia, or low calcium levels. Hypocalcemia can cause
numbness in fingers and toes, muscle cramps in legs and feet,
irritability, and seizures.10
The acquisition of Ai Biomed Corp. is the seventh in a series of
tuck-in acquisitions that Medtronic has made in calendar year 2020.
The revenue and earnings contribution is expected to be immaterial
to the Medtronic ENT business in the first year and accretive
thereafter. In addition, this transaction is expected to meet
Medtronic's long-term financial metrics for acquisitions.
Additional terms of the agreement are not being disclosed. The Ai
Biomed Corp. facility in Santa Barbara,
Calif., and its employees joined Medtronic ENT as part of
the acquisition.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services, and
solutions companies – alleviating pain, restoring health, and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals, and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated
results.
REFERENCES
1. Dionigi G, et al. Why monitor the
recurrent laryngeal nerve in thyroid surgery? J Endocrinal Invest.
2010; 33: 819-822.
2. Dionigi G, et al. The technique of intraoperative
neuromonitoring in thyroid surgery. Surg Technol Int.
2010;19:25-37.
3. Sari S, Erbil Y, Sumer A et al. Evaluation of recurrent
laryngeal nerve monitoring in thyroid surgery. Int J Surg
2010;8(6):474-478.
4. Wilson JA, Deary IJ, Miller A, et al. The quality of life
impact of dysphonia. Clin Otolaryng 2002;27:179-82.
5. Di Marco AN, Palazzo FF. Near-infrared autofluorescence in
thyroid and parathyroid surgery. Gland Surg 2020;9(Suppl
2):S136-S146.
6. Duran M, et al. Recurrent Laryngeal Nerve Branching. The
Recurrent and Superior Laryngeal Nerves, 2016; 8: 83-91.
7. Lubitz, C, et al. The Nonrecurrent Inferior Laryngeal
Nerve. The Recurrent and Superior Laryngeal Nerves, 2016; 11:
115-123.
8. Randolph GW and Dralle H with the International
Intraoperative Monitoring Study Group. Electrophysiologic recurrent
laryngeal nerve monitoring during thyroid and parathyroid surgery:
international standards guideline statement. Laryngoscope 2011;
121:S1-S16.
9. Data on file.
10. Murphy, E, Williams G. Hypocalcaemia. Medicine, 2005;
33(12):55-57.
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SOURCE Medtronic plc