Medtronic Announces Second Bone Cement Solution Indicated for Treating Sacral Fractures
21 June 2018 - 12:00AM
Delivering
Commitment to Find New Treatment Options for Patients
Suffering from Sacral Insufficiency
Fractures
DUBLIN - June 20, 2018-
Medtronic plc (NYSE: MDT) today announced the U.S. Food and Drug
Administration (FDA) has granted 510(k) clearance of Kyphon(TM)
HV-R Bone Cement for fixation of pathological fractures of the
sacral vertebral body (or ala) using sacral vertebroplasty or
sacroplasty. This broadens Medtronic's commitment to treat
fragility fractures beyond vertebral compression fractures caused
by osteoporosis, cancer or benign lesions. With this expanded
indication for Kyphon HV-R Bone, clinicians now have more options
for treating patients with sacral insufficiency fractures.
"Patients who experience sacral insufficiency
fractures often suffer a substantial degree of pain and
disability," said Dr. Thomas Andreshak, orthopedic surgeon, Mercy
St. Vincent Medical Center and St. Luke's Hospital, Maumee, Ohio.
"This new indication for Kyphon HV-R cement, along with Kyphon(TM)
Xpede Bone Cement will provide another excellent option to help
these patients."
Sacral insufficiency fractures (SIFs) are a common
cause of debilitating back pain. SIFs mimic the symptoms of lumbar
spine pathology.1 Studies show
more than two-thirds of patients diagnosed with SIFs aren't able to
associate their pain with a traumatic event.2 As a
result, physicians often prescribe conservative treatment,
including physical therapy and prolonged bed rest. These patients
report 20-45-day inpatient stays1 at the
hospital, and prescription narcotic use associated with pain from
untreated sacral insufficiency fractures, which are significant
expenses to the healthcare system and result in lost productivity.
Patients treated with bed rest are at increased risk of pulmonary
embolism and DVT, as well as further muscle atrophy and bone
loss.3
"In my practice, patients with sacral
insufficiency fractures treated with sacroplasty experience
immediate pain relief that allows them to resume daily activity
and/or physical therapy without suffering from pain and physical
limitations," said Dr. Labib F. Haddad, interventional radiologist,
West County Radiological Group, St. Louis, Mo. "The procedure of
sacroplasty with HV-R cement is a minimally-invasive procedure
usually performed in an outpatient setting."
"Early intervention is an important consideration
for both hospital costs and patient outcomes," said Jeff Cambra,
vice president and general manager of the Interventional Pain
Therapies business, which is part of the Restorative Therapies
Group at Medtronic. "Combined with our 20 years of experience in
vertebral compression fractures, this new indication for our bone
cement solution allows us to continue to make an impact on
vertebral compression fracture and sacral insufficiency diagnosis
treatment in the U.S. by giving physicians options to deliver the
best clinical solutions to their patients."
About Kyphon Bone Cement
Solutions
Kyphon Xpede Bone Cement and Kyphon HV-R Bone Cement are indicated
for the treatment of pathological fractures of the vertebral body
due to osteoporosis, cancer, or benign lesions using a
cementoplasty (i.e., kyphoplasty or vertebroplasty) procedure. It
is also indicated for the fixation of pathological fractures of the
sacral vertebral body or ala using sacral vertebroplasty or
sacroplasty. Cancer includes multiple myeloma and metastatic
lesions, including those arising from breast or lung cancer, or
lymphoma. Benign lesions include hemangioma and giant cell tumor.
Pathologic fracture may include a symptomatic microfracture (as
documented by appropriate imaging and/or presence of a lytic
lesion) without obvious loss of vertebral body height.
Balloon kyphoplasty incorporates technology
developed by Gary K. Michelson, M.D.
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 86,000 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.
-end-
1. Ortiz AO, et al. Sacroplasty. Tech Vasc Interv Radiol. 2009: 12(1); 51-63. doi:
10.1053.
2. Wagner D, Ossendorf C, Gruszka D, Hofmann A, Rommens PM.
Fragility fractures of the sacrum: how to identify and when to
treat surgicall? Eur J Trauma Emerg. Surg.
2015; 41(4): 349-362. doi: 10.1007/s00068-015-0530-z.
3. Dittmer et al. Complications of immobilization and bed
rest. Part 1: Musculoskeletal and cardiovascular complications. Can
Fam Physician. 1993 Jun; 39: 1428-32, 1435-7.
Contacts:
Victor Rocha
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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