FDA Clears Expanded Indications for Medtronic NuVent(TM) EM Sinus Dilation System with Image Guidance
July 11 2016 - 9:00AM
Clinical Study
Conducted on Revision Subjects Support Expanded Indication for
Patients with Previously Surgically Altered Tissue
DUBLIN - July 11, 2016 -
Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug
Administration (FDA) clearance of NuVent(TM), an EM sinus dilation
system, for patients with scarred, granulated, or previously
surgically-altered tissue - an expansion of indications. Patients
coming in for revision sinus surgery (RSS) have these tissue
characteristics. NuVent is the first and only balloon sinus
dilation system with built-in electromagnetic (EM) surgical
navigation technology that may help surgeons confirm
anatomy1 and optimize
placement2 during
balloon sinus surgery. RSS may be needed when sinus surgery does
not alleviate suffering, and can pose unique challenges due to
potential scar tissue and altered anatomy from previous surgeries.
Image-guided surgery may have advantages for some types of revision
cases.3
"NuVent is an ingenious surgical tool that
combines automatic calibration, precise electromagnetic navigation,
and balloon dilation technology all in one device," said Rick
Chandra, M.D., professor of otolaryngology, chief of rhinology,
sinus & skull base surgery, Vanderbilt University. "It has been
extraordinarily useful in accomplishing the goals of revision
functional endoscopic sinus surgery, particularly to address
technical challenges associated with the frontal sinus."
Surgical navigation is important because sinus
anatomy can be highly variable. NuVent was designed to work with
image guidance technology called the Fusion(TM) ENT Navigation
System, which is a GPS-like navigation system that helps physicians
target blocked sinuses4 during a
minimally invasive surgery5 performed in
the office. Fusion(TM) navigation technology helps physicians
confirm specific anatomy, avoid critical areas,6 and
optimize balloon placement to open blocked pathways.It works like
GPS in a car or on a phone and displays a visual map of the sinus
anatomy. This may help surgeons steer the balloon to the blocked
sinuses to inflate the balloon at the precise location to
reshape(dilate)the tissue and bone to clear the sinus pathway.
When performed in the doctor's office, this
procedure is minimally invasive, offers faster recovery
times4 and may allow
eligible patients to have a lower out-of-pocket cost.7
The FDA clearance of NuVent for patients who have
scarred, granulated, or previously altered tissue (revision) was
based on the results of a prospective, non-randomized, non-blinded,
single arm study conducted at investigational sites in the United
States to assess the safety and device performance of the
system.
"As the first sinus dilation system for revision
surgery and the first with built-in electromagnetic tracking,
NuVent is an example of transformative technology that provides
meaningful benefits to patients and physicians and it has the
potential to help improve patient outcomes and reduce out-of-pocket
costs," said Vince Racano, vice president and general manager of
Medtronic's ENT business, which is part of the Restorative
Therapies Group at Medtronic. "Our innovative image-guided system
used with NuVent provides surgeons with a detailed view of the
sinus anatomy during the procedure and may enhance precision and
allow physicians to help more patients in office."
NuVent now offers a 70° angled frontal probe,
which is a familiar angle for sinus surgery, to be used with the
FUSION system. Additionally, a compact version of Medtronic's
FUSION(TM) system called FUSION Compact(TM) system was recently
launched. This modular, portable system gives physicians the
freedom to use navigation where they need it.
For more information about the NuVent procedure,
please visit http://www.sinusitissurgery.com to find new resources,
including a physician finder.
About Sinusitis
Sinusitis is inflammation of the sinuses and nasal passages, which
can become infected. About 31 million suffer from sinusitis and
those with symptoms for 12 weeks or more are said to have chronic
rhinosinusitis8. Many
struggle for years before finding relief; a survey of 400 CRS
sufferers, found that more than half suffering for 15 years or
more.9Sinusitis
causes significant physical suffering and emotional struggles,
including headaches,8 facial
pain8 missed
work9, personal
engagements9, limited
physical activities9, and problems sleeping.10
It may be treated with antibiotics, decongestants
and saline sprays. However, when medical management fails to
relieve symptoms, sinus surgery has been proven to improve overall
symptoms to reduce headaches,11 work/school
time missed, frequency of doctor/nurse visits and acute
infections.10
Multimedia Release
A multimedia version of this release, with downloadable graphics
and backgrounders, can be found at: http://bit.ly/29rhenb.
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 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 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.
-end-
1 Dustin
M. Dalgorf, Raymond Sacks, Peter-John Wormald, Yuresh Naidoo, Ben
Panizza, Brent Uren, Chris Brown, John Curotta, Kornkiat Snidvongs
and Richard J. Harvey Dustin M., Image-Guided Surgery Influences
Perioperative Morbidity from Endoscopic Sinus Surgery: A Systematic
Review and Meta-Analysis. Otolaryngol Head Neck
Surg. 2013 149:17
2 Data on
File, Medtronic plc
3 Farhadi
M, Jalessi M, Sharifi G., Khamesi S, Bahrami E, Hammami MR, Behzadi
AH. Use of image guidance in endoscopic endonasal surgeries: A
5-year experience. B-ENT,
2011;7(4):277-82.
4 Data on
File, Medtronic plc
5 Bikhazi
N. Light J, Truitt T, Schwartz M, Cutler J, and REMODEL study
investigators. Standalone balloon dilation versus sinus surgery for
chronic rhinosinusitis: A prospective, multicenter, randomized,
controlled trial with 1-year follow-up. AM J
Rhnino Allergy. 2014:28(4):323-329.
6 Assen
Koitschev, Christian Simon, Hubert Wenheim, Thomas Naegele &
Ulrlke Ernemann. Management and outcome after internal carotid
artery laceration during surgery of the paranasal sinuses.
Acta Oto-Laryngologica, 2006; 126: 730_738
7 Silvers
SL. Practical techniques in office-based balloon sinus dilation.
Operative Techniques Otolaryngol.
2014;25:206-212.
8 Rosenfeld
RM, Andes D, Bhattacharyva N, et al. Clinical practice guidelines:
Adult sinusitis. Otolaryngol Head Neck Surg.
2007;137-S1-S31.
9 Data on
File. Medtronic plc
10 Chandra
RK, Kern RC, CutlerJL, Et al. REMODEL larger cohort with long-term
outcomes and meta-analysis of standalone balloon dilation studies.
Laryngoscope. 2016;126(1):44-50.
11 Marzetti
A. Tedaldi M., Passali FM. The role of balloon sinuplasty in the
treatment of sinus headache. Otolaryngol
Polska. 2014;68:15-19.
Contacts:
Candy Bowen
Public Relations
+1-904-332-8163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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