Late-Breaking Study Provides Evidence to Support Beneficial Seven-Year Clinical Outcomes and Patient Satisfaction for 2-Level...
May 03 2016 - 9:00AM
Study Represents
Longest Patient Follow-Up Data for U.S. 2-Level Cervical Disc
Patients
DUBLIN and CHICAGO - May 3, 2016
- Medtronic plc (NYSE: MDT) today announced results of
seven-year follow-up data demonstrating favorable clinical outcomes
and patient satisfaction for the 2-level Prestige LP(TM) Cervical
Disc compared to 2-level anterior cervical discectomy and fusion
(ACDF). The Prestige LP Disc - currently indicated for single-level
cervical disc disease causing nerve or spinal cord compression from
C3-C7 - is pending FDA PMA approval for 2-level use. The device is
designed to preserve motion in the neck at the operated disc level,
unlike a fusion surgery that does not allow for motion. The
Prestige LP Disc is the third clinically-proven artificial cervical
disc in Medtronic's portfolio. The Prestige LP Disc has a
ball-and-trough design and moves in a range of motions, including
bending, rotation and translation.
The data will be presented today during the
late-breaking session at the 84th Annual
Meeting of the American Association of Neurological Surgeons (AANS)
in Chicago, IL by Todd Lanman, M.D., a neurosurgeon at the
Cedar-Sinai Institute for Spinal Disorders in Los Angeles, CA.
"The seven-year results of this study show that
the patients receiving 2-level cervical disc replacement exhibited
beneficial clinical outcomes and maintained them over time," said
Dr. Lanman. "At 84 months, the patients treated with the 2-level
Prestige LP Disc demonstrated greater rates of overall success
compared to the 2-level ACDF patients."
The randomized controlled investigational device
exemption (IDE) trial included a total of 397 study subjects (209
investigational and 188 control) and compared results up to seven
years. Key findings of the statistical analysis at seven years show
that the 2-level Prestige LP Disc patients:
- Exhibited greater rates in overall success
(78.6%) compared to the patients treated with 2-level ACDF (62.7%)
(by using Bayesian statistics, probability of superiority =
99.8%).1
- Exhibited greater rates in neurological success
(91.6%) compared to the patients treated with 2-level ACDF (82.1%)
(probability of superiority= 99.0%).
- Exhibited greater success rates in
patient-reported outcomes, including Neck Disability Index (87.0%),
compared to the patients treated with 2-level ACDF (75.6%)
(probability of superiority = 99.3%).
- Exhibited lower rates of second surgeries (4.2%)
at the index levels compared to the patients treated with 2-level
ACDF (14.7%).
- Adverse event profiles were similar between
groups.
Risks of the Prestige LP Disc include, but are not
limited to: bone formation (including heterotopic ossification)
that may reduce spinal motion or result in a fusion, either at the
treated or at adjacent levels.
"This is the longest follow-up data available on
clinical study patients treated with 2-level cervical arthroplasty
in the United States," said Tommy Carls, vice president of Research
and Development for the Spine division, which is part of the
Restorative Therapies Group at Medtronic. "We're committed to
developing meaningful innovations - like the Prestige LP Disc -
that fundamentally change patients' lives. That's why it's exciting
to see that the patients treated with the Prestige LP Disc maintain
their outcomes for seven years."
About Medtronic's Spinal
Business
We shape spine surgery for the better - delivering smarter
procedures and healing biologics. As a global leader, we partner
with other healthcare stakeholders to accelerate innovations that
create surgical efficiencies and improve outcomes for more
patients. More information about spinal treatments can be found at
our patient-education website, www.back.com.
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 Overall
Success is decided by combining the results from four different
measurements of safety and effectiveness.
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#2009352
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2024 to May 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From May 2023 to May 2024