Medtronic's OsteoCool(TM) RF Ablation System Receives Expanded Indication for Palliative Treatment of Metastatic Bone Tumors
February 15 2017 - 7:00AM
Minimally-Invasive
Procedure Is First of its Kind in the U.S. to Bring Relief
to
Patients Suffering from Metastatic Bone
Tumors
DUBLIN - Feb. 15, 2017 -
Medtronic plc (NYSE: MDT) today announced that the U.S. Food and
Drug Administration (FDA) has cleared an expanded indication for
the OsteoCool(TM) RF Ablation System. Originally cleared for use in
the spine, the FDA now allows the marketing of the OsteoCool System
for palliative treatment of metastases in all bony anatomy - such
as ribs, sacrum, extremities, and hip - in patients who have failed
or are not candidates for standard therapy. The system uses
targeted radiofrequency energy to ablate malignant metastatic bone
tumors.
"Patients with metastatic bone cancer may be
treated with conventional therapies such as opioids, chemotherapy
or radiation therapy for pain palliation," said Sandeep Bagla,
M.D., an interventional radiologist with the Vascular Institute of
Virginia in Woodbridge, Va. "With the expanded indication for the
OsteoCool System, I now have the option to ablate these patients'
painful bone tumors when conventional therapies are considered
ineffective, too slow-acting or cause unacceptable side
effects."1
Metastatic bone disease has been reported to occur
in 60-80 percent of cancer patients, most frequently among patients
with primary malignancies of the breast, prostate, liver, and
lung.2 More
than 80 percent of bone metastases are found in the axial skeleton,
which includes the skull, spine, and ribs.3
"Our Pain Therapies business is deeply rooted in
the Medtronic Mission - which calls us to alleviate pain,"said Jeff
Cambra, general manager of the Pain Therapies Interventional
business, which is part of the Restorative Therapies Group at
Medtronic. "With this expanded indication, we put an important
treatment option into the hands of physicians so that they can help
more patients suffering from debilitating pain."
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.
"We're pleased to broaden our partnership with
Medtronic to improve the treatment of patients suffering from
painful metastases," said Kris Shah, president of Baylis
Medical. "The expansion of the OsteoCool System to include
the ablation of malignant lesions in bone adds to our company's
track record of offering innovative clinical solutions and further
enhancing patient access and treatment options."
The OsteoCool system is the only cooled
radiofrequency (RF) ablation technology that offers simultaneous,
dual-probe capabilities - providing for procedural flexibility and
predictable, customized treatment. The system is temperature
controlled and uses internally water-cooled probes to prevent
overheating of surrounding tissue during the procedure.
The device also has a CE mark for the ablation of
benign bone tumors such as osteoid osteoma and palliative treatment
of metastatic malignant lesions involving bone, including the
vertebral body. This indication is not available in the United
States.
Medtronic's OsteoCool(TM) RF Ablation
System
Click the thumbnail above for a larger image.
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),
London (U.K.) and Munich (Germany). 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 88,000 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 Gangi et
al. Image-Guided Ablation Therapy of Bone Tumors. Elsevier Inc.,
2009.
2 Schuleman
et al. Economic Burden of Metastatic Bone Disease. American Cancer
Society, 2007.
3 Nielson
et al. Bone Metastases: Pathophysiology and Management Policy.
American Society of Clinical Oncology, 1991.
Contacts:
Victor Rocha
Public Relations
+1-901-399-2401
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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