DUBLIN, Dec. 15, 2020 /PRNewswire/ -- Medtronic plc
(NYSE: MDT) today announced the release of outcomes in the first
100 patients treated with the OsteoCool™ Radiofrequency Ablation
(RFA) System in the OPuS One Clinical Study (as referenced below) –
the largest, prospective study in RFA for bone metastases. The
study, which is the most meaningful clinical data release for the
OsteoCool™ technology to date, showed patients had
significant and swift improvement in pain relief at
just three days post-procedure and sustained improvements in
pain and quality of life out to six months. The results were
published in the November edition of the Journal of Vascular and
Interventional Radiology.
"The rapid pain relief was arguably the most important finding
from the study. Also, given the significant improvement in quality
of life we saw in such a sick patient population, we're hopeful
this meaningful data provides evidence to support moving this
therapy up earlier in the cancer treatment paradigm."
Jason Levy, MD,
Interventional radiologist, Northside Hospital System,
Atlanta GA.
Cancer that has metastasized, or moved to surrounding bone, can
affect quality of life, producing complications such as pain,
fractures, and decreased mobility.1 In addition to these
symptoms, bone metastases can cause mood changes such as depression
and anxiety.2 Radiation therapy is traditionally
considered the gold standard palliative treatment for patients with
bone metastases. But 1 in 3 cancer patients are left with
inadequate treatment or undermanaged pain control because
treatments like opioids, chemotherapy, and radiation therapy did
not work for them.3 OsteoCool™ system can be used as an
adjunctive treatment in this instance and it does not disrupt other
systemic therapies.
"Our Interventional Pain Therapies business is inherently
connected to the Medtronic Mission – which calls us to alleviate
pain," said Anu Codaty, vice president and general manager of
Medtronic's Interventional Pain Therapies business, which is
reported as part of the Restorative Therapies Group. "With this
data, we hope to bring awareness to a treatment option that can
quickly help cancer patients suffering from debilitating pain."
According to the study results, patients treated with RFA
achieved significant improvements in pain relief (worst and average
pain) at all visits. Results showed rapid pain improvement as early
as 3 days and sustained out to 6 months. Patients in the
study also achieved significant improvements in pain interference
and quality of life at all visits. Pain interference measures seven
interference items (general activity, mood, walking ability, normal
work, relations with other people, sleeping, and enjoyment of
life).
The multicenter center study included a total of 218 patients at
16 centers in the United States,
Europe, and Canada. Follow-up was completed on patients
immediately post-RFA, 3 days, 1 week, and 1-, 3-, 6-, and 12-months
post-procedure. The newly released data on pain, quality of life,
medication, and safety included outcomes out to 6 months in the
first 100 patients.
The OPuS One primary endpoint was achieved through these results
– to demonstrate an improvement from baseline to 3 months post-RFA
in worst pain score in the past 24 hours in subjects treated for
metastatic lesions in only the thoracic and/or lumbar vertebral
body(ies). Eighty-seven percent of patients had tumors involving
the thoracolumbar spine and thirteen percent had tumors located in
the pelvis and/or sacrum.
More information can be found at www.medtronic.com/opusone.
Additional study details can be found at clinicaltrials.gov.
About the OsteoCool™ Radiofrequency Ablation
System
The OsteoCool™ System is intended for palliative
treatment in spinal procedures by ablation of metastatic malignant
lesions in a vertebral body and for ablation of benign bone tumors
such as osteoid osteoma. It is also intended for coagulation and
ablation of tissue in bone during surgical procedures including
palliation of pain associated with metastatic lesions involving
bone in patients who have failed or are not candidates for standard
therapy. The system is contraindicated for use in the cervical
spine. Risks for the system include damage to surrounding tissue
through iatrogenic injury as a consequence of electrosurgery,
pulmonary embolism, and nerve injury including thermal injury,
puncture of the spinal cord or nerve roots potentially resulting in
radiculopathy, paresis, and paralysis.
About the J Vasc Interv Radiol (JVIR) Publication
Levy
J, Hopkins T, Morris J, et al. Radiofrequency Ablation for the
Palliative Treatment of Bone Metastases: Outcomes from the
Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One
Study) in 100 Patients. J Vasc Interv Radiol 2020;
31:1745–1752. https://doi.org/10.1016/j.jvir.2020.07.014
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 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 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.
- Goetz, et al. Percutaneous Image-Guided Radiofrequency Ablation
of Painful Metastases Involving Bone: A Multicenter
Study. J Clin Oncol. 2004; 22 (2): 300-306.
- Spiegel D, et al. Pain and depression in patients with
cancer. Cancer. 1994;74:2570-2578.
- Anselmetti, et al. Treatment of Extraspinal Painful Bone
Metastases with Percutaneous Cementoplasty: A Prospective Study of
50 Patients. Cardiovasc Intervent Radiol.
2008;31:1165-1173.
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SOURCE Medtronic plc