Medtronic Receives FDA Approval for Two-Level Prestige LP(TM) Cervical Disc Procedures
July 18 2016 - 9:00AM
Two-Level Use of
Prestige LP Cervical Disc Exhibited Statistical Superiority in
Overall Success at 24 Months Compared to
Patients Treated with Two-Level Fusion
DUBLIN - July 18, 2016 -
Medtronic plc (NYSE: MDT) announced today the U.S. Food and Drug
Administration's (FDA) approval of the Prestige LP(TM) Cervical
Disc for the treatment of cervical disc disease causing nerve or
spinal cord compression at two adjacent levels between the C3-C7
segments of the neck. The Prestige LP Disc is designed to allow
motion in the neck at the operated levels, unlike a fusion surgery
that does not preserve motion.
The Prestige LP Disc is Medtronic's third
clinically-proven artificial cervical disc and its first to be
determined safe and effective for both one- and two-level
procedures. Additionally, it is the first artificial disc on the
U.S. market to be proven statistically superior in overall success
for both one- and two-level procedures.
"For my active patients with cervical disc disease
at two adjacent levels, I want to preserve motion in their necks,"
said Dr. Jeff McConnell, a clinical trial investigator and
orthopedic surgeon at Lehigh Valley Hospital in Allentown, Pa. "I
choose to use the Prestige LP Disc at two levels because it
provides superior clinical outcomes at 24 months and the titanium
ceramic composite material allows post-op assessment and
visualization by MRI."
Two pivotal clinical trials - a single-level and a
two-level trial - were conducted to support the safety,
effectiveness and FDA approval of the Prestige LP Disc. The
two-level clinical trial included 397 patients (209 investigational
and 188 control patients) at 30 sites around the U.S. At 24 months,
the Prestige LP patient group demonstrated statistical superiority
in overall success compared to patients treated with a two-level
anterior cervical discectomy and fusion (ACDF). Overall success
required a patient to meet all criteria for neurologic success,
Neck Disability Index success, absence of serious, device-related
adverse events, and absence of secondary surgeries at the treated
levels. Overall success rates at 24 months were 81.4% in the
investigational group and 69.4% in the control group. The posterior
probability of superiority of the investigation group over the
control group was 99.3%.
"Medtronic is committed to elevating spine care by
combining innovative new technologies with clinical evidence," said
Doug King, senior vice president and president of Medtronic's Spine
division, which is part of the Restorative Therapies Group at
Medtronic. "The Prestige LP Disc is a superior alternative to ACDF
and an important motion-preserving option for physicians treating
certain patients suffering from two-level cervical disc
disease."
Risks of the Prestige LP Disc include, but are not
limited to: development of new nerve or spinal cord compression or
pain; allergic reaction to implanted material; or bone formation
(including heterotopic ossification) that may reduce spinal motion
or result in a fusion, either at the treated or at adjacent
levels.
The low profile Prestige LP Disc has a
ball-and-trough design and moves in a range of motions, including
bending, rotation, and translation. The disc is made of titanium
ceramic composite which provides improved wear resistance in
combination with the mechanical, biocompatible, and imaging
properties of the base titanium alloy. The device is MRI
conditional at 1.5 and 3.0 Tesla and is now available in a smaller
5mm height.
About Prestige LP Cervical
Disc
The Prestige LP Cervical Disc is indicated in skeletally mature
patients for reconstruction of the disc from C3-C7 following
discectomy at one level or two contiguous levels for intractable
radiculopathy (arm pain and/or a neurological deficit) with or
without neck pain, or myelopathy due to abnormality localized to
the level of the disc space and at least one of the following
conditions confirmed by imaging (CT, MRI, X-rays): herniated
nucleus pulposus, spondylosis (defined by the presence of
osteophytes), and/or visible loss of disc height as compared to
adjacent levels. The Prestige LP Disc is implanted using an
anterior approach. Patients should have failed at least 6 weeks of
non-operative treatment or have had the presence of progressive
symptoms or signs of nerve root/spinal cord compression in the face
of continued non-operative management prior to implantation of the
Prestige LP Disc.
About Medtronic's Spine
Division
We shape spine surgery for the better - delivering smart procedures
and therapeutic biologics. As a global leader, we partner with
other healthcare stakeholders to accelerate innovations that can
improve surgical efficiencies and help create better outcomes for
more patients.
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-
Contacts:
Victor Rocha
Public Relations
+1-901-399-2401
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
HUG#2028991
Medtronic (NYSE:MDT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Sep 2023 to Sep 2024