Medtronic Expands Pain Therapies Portfolio with the Launch of OsteoCool(TM) RF Ablation System
January 13 2016 - 8:00AM
Minimally-Invasive
Procedure Brings Relief to Patients
Suffering from Painful Spine Tumors
DUBLIN - January 13, 2016 -
Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug
Administration (FDA) 510(k) clearance and U.S. launch of the
OsteoCool(TM) RF Ablation System. For physicians who treat
patients with painful spine metastases, the OsteoCool System is the
only cooled radiofrequency (RF) ablation technology that offers
simultaneous, dual-probe capabilities - providing procedural
flexibility and predictable, customized treatment. Cooled RF
ablation uses targeted high-frequency energy to destroy cancer
cells.
"The most common complaint associated with spine
metastases is pain - it's often progressive and significantly
reduces the patient's quality of life," said Sandeep Bagla, MD, an
interventional radiologist with the Vascular Institute of Virginia
in Woodbridge, VA. "With the OsteoCool system, I can now
ablate the patient's painful tumor with a reproducible procedure
that's appropriate for their unique anatomy."
Metastatic bone disease has been reported to occur
in 60-80% of cancer patients, most frequently among patients with
primary malignancies of the breast, prostate, liver, and
lung.i Seventy
percent of metastatic bone cancer patients develop at least one
lesion in the spine.ii
"The OsteoCool System expands our Pain Therapies
portfolio," said Julie Foster, general manager and vice president
of the Pain Therapies business in the Neuromodulation division,
which is part of the Restorative Therapies Group at Medtronic.
"Our customers treat patients with Kyphon® Balloon
Kyphoplasty who also have painful spinal metastases. The
OsteoCool system gives physicians a way to treat that pain in a
single procedure with a familiar, minimally invasive
technique."
In November, Medtronic received expanded
indications for Kyphon Xpede® Bone Cement, which now includes
clearance for the treatment of microfractures that can be caused by
cancer cells breaking down bone (forming osteolytic lesions).
Where indicated, the OsteoCool Bone Access Kit can be used for a
subsequent, physician-directed procedure such as cementoplasty
(i.e., vertebroplasty or kyphoplasty).
Medtronic acquired the OsteoCool technology and
associated intellectual property from Baylis Medical on December
16, 2015 and partnered with the company to further innovate the
system. Terms of the acquisition were not disclosed.
"We're pleased to be partnering with Medtronic to
improve the treatment of patients suffering from spinal
metastases," said Kris Shah, president of Baylis Medical.
"Our company has a long, established track record of
developing innovative clinical solutions. We are excited that
this partnership with Medtronic will enhance patient access to our
novel spinal tumor ablation technology."
The system is temperature controlled and uses
internally water-cooled probes to prevent overheating of
surrounding tissue during the procedure. The 17-gauge,
bipolar probes are available in three lengths and may be used
through a variety of cannula sizes. Because two OsteoCool RF
ablation probes can be used simultaneously, the system supports a
variety of ablation scenarios accommodating unique patient and
procedural needs. The device is currently pending CE
marking.
Multimemedia
Release
A multimedia version of this release with animation can be found
at: http://bit.ly/1mWWbM2
About Baylis Medical
Company
Baylis Medical develops and markets high-technology medical devices
used in the fields of interventional cardiology, interventional
radiology, and spinal procedures. Our vision is to develop
and market innovative medical therapies while Improving the Lives of People Around the World.
The company has offices in Montreal and Toronto (Canada),
Boston (USA), and London (U.K.). For more information, visit
www.baylismedical.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.
i Schuleman et
al. Economic Burden of Metastatic Bone Disease.
American Cancer
Society 2007.
ii 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.
Kyphon Balloon Kyphoplasty incorporates technology
developed by Gary K. Michelson, M.D.
-end-
Contacts:
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Public Relations
+1-901-399-2401
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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