Medtronic Receives First-Ever FDA Clearance for Cement-Augmented Pedicle Screws
July 20 2016 - 10:00AM
Clearance Gives
Spine Surgeons a New Treatment Option for Spinal Tumors
Patients
DUBLIN - July 20, 2016 -
Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug
Administration (FDA) 510(k) clearance of the CD Horizon®
Fenestrated Screw Set, which can be used for patients diagnosed
with advanced stage tumors involving the thoracic and lumbar spine.
This marks the first U.S. clearance for cement-augmented pedicle
screws. The CD Horizon® Fenestrated Screws are used with
Medtronic's HV-R® Fenestrated Screw Cement, a
polymethylmethacrylate (PMMA) cement, and are intended for use at
spinal levels where the structural integrity of the spine is not
severely compromised.
Metastatic bone disease has been reported to occur
in 60-80% of cancer patients, most frequently among those with
primary malignancies of the breast, prostate, liver, and
lung.1The spine is
the most common site of bone metastasis and can be impaired by
metastatic bone tumors.2Cement-augmented
screws are designed to restore spinal stability in
patients whose life expectancy is insufficient to allow for fusion
to occur.
"Current cancer treatments can weaken a patient's
bones and primary malignancies often spread to the spine, which
cause considerable pain and are complex to manage," said Francis H.
Shen, M.D., orthopedic surgeon, Charlottesville, Va. "When placed
into compromised bone, traditional screws run the risk of loosening
over time. The ability to utilize cement augmentation directly
through a fenestrated screw is a great advancement. It allows me to
achieve immediate implant stability, which would not be possible
with traditional non-augmented screws. More importantly this allows
me to help to mobilize my patients more quickly."
Medtronic's CD Horizon Fenestrated Screw Set
features cannulated pedicle screws designed with six holes
(fenestrations) located near the end of the screw, allowing
controlled cement injection into the targeted vertebral body after
having placed all of the screws. This self-curing PMMA cement
provides immediate screw fixation in the patient's spine and
significantly increases the screw pull-out strength compared to
standard screws*. The cement is injected through a continuous tract
in the adapter and into the screw cannula. This continuous tract
delivery system is designed to have a completely secure channel
that can be visually verified outside the patient to help reduce
the likelihood of cement leakage at the adapter/screw interface
while being compatible for minimally invasive surgery (MIS) and
open procedures.
"Palliative care is important for people with
cancer, and Medtronic's cement-augmented screws are a meaningful
innovation that are designed to restore the integrity of the spinal
column in patients with debilitating spinal tumors," said Doug
King, senior vice president and president of Medtronic's Spinal
division, which is part of the Restorative Therapies Group at
Medtronic. "The availability of our CD Horizon Fenestrated Screw
Set represents an important advance for surgeons and provides them
with another option for a complex procedure."
The CD Horizon Fenestrated Screw Set will be
available this fall.
CD Horizon Fenestrated Screw Set incorporates the
technology of Gary K. Michelson, MD.
About Medtronic's Spinal
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. More information about spinal treatments can be
found at our patient education Web site, 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
focuses 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-
* Pull-out strength results are based upon direct
comparisons of CD Horizon® Fenestrated Screws to non-cement
augmented CD Horizon® Legacy MAS Screws performed in a cadaver
study. Cadaver results are not necessarily indicative of clinical
outcomes.
1 Schulman et
al. Economic burden of metastatic bone disease. American Cancer
Society 2007:2334-2342.
2 Chow E,
Finkelstein JA, Sahgal A, Coleman RE. Metastatic cancer to
the bone. In: DeVita VT, Lawrence TS, Rosenberg SA, eds. DeVita,
Hellman, and Rosenberg's Cancer: Principles & Practice of
Oncology. 9th ed. Philadelphia, Pa: Lippincott Williams &
Wilkins; 2011: 2192-2204.
Contacts:
Victor Rocha
Public Relations
+1-901-399-2401
Ryan Weispfennig
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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