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KYPHONŽ BALLOON KYPHOPLASTY FOUND BENEFICIAL FOR TREATING
SPINAL FRACTURES IN CANCER PATIENTS
Study Showed Minimally Invasive Procedure Provided Better Back Function, More Rapid Back
Pain Relief and Improved Quality of Life Compared with Nonsurgical Care
MINNEAPOLIS February 16, 2011 Medtronic Inc., (NYSE: MDT) today announced
the results of the first randomized, controlled trial comparing Kyphon Balloon
Kyphoplasty with nonsurgical care in treating spinal fractures in cancer patients.i The
study found that Kyphon Balloon Kyphoplasty provided cancer patients better back
specific function, more rapid back pain relief and improved quality of life compared
with nonsurgical care one month after treatment.
The study was published today in the online edition of The Lancet Oncology. It involved
134 patients with vertebral compression fractures who also had various types of cancer
such as breast, lung, and prostate or had multiple myeloma and took place at 22 sites in
the U.S., Europe, Australia and Canada.
The study, Cancer Patient Fracture Evaluation or CAFE, was sponsored by the Kyphon
Products Division of Medtronic. It provided clinical evidence for the benefits of Kyphon
Balloon Kyphoplasty compared with standard nonsurgical care. Devices to perform
Kyphon Balloon Kyphoplasty for both patients with cancer and those with osteoporosis
are sold by Medtronic.
"The results of this landmark study should be welcomed news to cancer patients across
the world suffering from the debilitating effects of painful vertebral compression
fractures," said Dr. James Berenson, the studys first author and Medical and Scientific
Director of the Institute for Myeloma and Bone Cancer Research in West Hollywood,
CA. "It is documented that nearly onefourth (24 percent) of patients with multiple
myeloma, 14 percent with breast cancer, 8 percent with lung cancer and 6 percent with
prostate cancer suffer painful vertebral compression fractures. With the results of this
new randomized study, there is now clinical evidence of a treatment option for spinal
fractures in cancer patients that can provide excellent relief of pain and improved
quality of life.
Patients in the CAFE study were randomized to either a Kyphon Balloon Kyphoplasty
group (n=70) or a nonsurgical control group (n=64). Members of both groups were able
to receive nonsurgical care, such as pain medications, best rest, bracing, walking aids
and radiation therapy, as medically appropriate.
Multiple outcomes relating to quality of life, physical function and back pain were
evaluated in 129 patients (68 kyphoplasty and 61 nonsurgical patients). The primary
outcome was the change in backspecific function from baseline to one month between
the groups as measured by the validated RolandMorris Disability Questionnaire (RDQ)
score, with 0 equal to no disability and 24 equal to maximum disability.
The key findings of the study were as follows:
Better Backspecific Function The Kyphon Balloon Kyphoplasty group's
functional status as measured by the RDQ at one month showed clinically and
statistically significant improvement, with a mean improvement from baseline of
8.3 points (p<0.0001). The control group showed no statistically significant
change in RDQ score (0.1 points; p=0.83). At one month, more balloon
kyphoplasty patients (51/63, 81%) had clinical improvement in RDQ compared
with control patients (14/50, 28%) based on the smallest change needed for
clinical meaning (the twopoint minimal clinically important difference or MCID;
p<0.0001)
Rapid Back Pain Relief Seven days after treatment, Kyphon Balloon
Kyphoplasty patients experienced clinically and statistically significant
improvement in back pain from baseline of 3.8 points compared with the
minimal change of 0.3 points by the control group. The treatment effect for
improvement from baseline was -3.5 points (p<0.0001) within seven days and
-3.3 points (p<0.0001) at one month, in favor of balloon kyphoplasty.
Improved Quality of Life (QOL) Kyphon Balloon Kyphoplasty patients
experienced better improvements in QOL compared with the control group as
measured by both the SF36 physical and mental component summaries, which
are based on a 36item Short Form Health Survey. The balloon kyphoplasty
group showed a clinically and statistically significant 8.4 point improvement
(p<0.0001) compared with the control group in the SF36 Physical Component
Summary (measuring quality of life weighted on physical abilities) at one month.
Improvement of 3.5 points is considered clinically meaningful. Additionally, the
balloon kyphoplasty group showed a mean 11.1point improvement (p<0.0001)
compared with the control in the SF36 Mental Component Summary score
(measuring quality of life weighted on mental abilities) at one month.
Safety Findings Medical adverse events were similar at one month between the
two groups (26/70 experienced adverse events within the balloon kyphoplasty
group; 19/64 experienced adverse events within the control group). The most
common adverse events within one month were back pain (4/70 for kyphoplasty
and 5/64 for control) and symptomatic vertebral fracture (2/70 for kyphoplasty
and 3/64 for control). One balloon kyphoplasty patient had serious adverse
events at one month (intraoperative nonQwave myocardial infarction with
intermittent atrial fibrillation) related to anesthesia that resolved. There was no
difference in radiographic or clinical subsequent vertebral fractures between the
two groups at one month. A subsequent vertebral fracture within a month of the
index procedure observed in one balloon kyphoplasty patient (with cement
leakage to the adjacent disc) was a serious adverse event reported as related to
the device.
There are risks associated with the procedure (e.g., cement leakage), including serious
complications, though rare, some of which may be fatal. This procedure is not for
everyone. A prescription is required. Patients should consult their physicians for a
complete list of indications, contraindications, benefits, and risks. Only patients and
their physicians can determine whether this procedure is right for a particular patient.
"In the CAFE study, most balloon kyphoplasty patients experienced early pain
reduction and improved activity, mobility and ability to take part in daily activities,"
said Professor Leonard Bastian, director of the Department for Orthopedics, Trauma,
Hand, and Reconstructive Surgery at the Klinikum Leverkusen (Germany) and one of
the study's authors. "For patients treated conservatively, pain relief was delayed. This
rapid effect on pain from balloon kyphoplasty is important for cancer patients today as
many need to complete their scheduled cancer treatment.
Limitations
As with all clinical studies, there are limitations. A limitation of this study is that
randomization of treatment lasted for only the first month; however, this is considered
to be a standard timeframe to assess safety and improvements in pain and function in
this population. Due to ethical considerations of limited life expectancy, after one
month, patients were allowed to crossover from the control group to receive balloon
kyphoplasty and 38 of 64 (59%) chose to do so.' The study was not blinded, so
knowledge of treatment may have influenced outcomes; however both treatment
groups represent common medical practice. Nonsurgical care was not standardized,
but each study center was asked to provide care consistent with local practices. A
biopsy was not obtained in every case and, therefore, it is unknown whether a given
fracture was due to an osteolytic metastasis, radionecrosis, osteoporosis, or a
combination of these.
For more detailed information on the findings of the study, go to www.
compressionfracturestudy.com. This study is registered on www.clinicaltrials.gov,
number NCT00211237. For more information on Kyphon Balloon Kyphoplasty, go to
www.balloonkyphoplasty.com.
About Kyphon Balloon Kyphoplasty
During the minimally invasive Kyphon Balloon Kyphoplasty procedure, working tubes
are used to create small pathways into the fractured bone, generally on both sides of the
vertebral body. Orthopedic balloons are inserted and then inflated inside the fractured
bone in an attempt to return it to its correct position. Inflation and removal of the
balloons create cavities in the vertebral body that are filled with bone cement, forming
an "internal cast".
Balloon kyphoplasty differs from other surgical therapies for vertebral compression
fractures such as vertebroplasty, which is designed to stabilize the fracture without
correcting vertebral body deformity or providing a controlled fill and distribution of
bone cement. With balloon kyphoplasty, inflation of the balloons compacts the
cancellous bone, which may fill fracture lines. The presence of the space also allows a
more viscous bone cement to be injected under low manual pressure.
About the Spinal and Biologics Business at Medtronic
The Spinal and Biologics business is based in Memphis, Tenn. It is the global leader in
today's spine market and is committed to advancing the treatment of spinal conditions.
The Spinal and Biologics business works with worldrenowned surgeons, researchers
and innovative partners to offer stateoftheart products and technologies for
neurological, orthopedic, dental and spinal conditions. Medtronic is committed to
developing affordable, minimally invasive procedures that provide lifestylefriendly
surgical therapies. More information about the company and its treatment therapies can
be found at www.medtronic.com and its patienteducation Web sites, www.back.com,
www.iscoliosis.com, www.maturespine.com and www.necksurgery.com.
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology alleviating pain, restoring health and extending life for
millions of people around the world.
Kyphon Balloon Kyphoplasty incorporates technology developed by Gary K.
Michelson, M.D.
Any forwardlooking 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
i Berenson J, Pflugmacher R, Jarzem P, Zonder J, Schechtmann K, Tillman JT, Bastian L, Ashraf T, Vrionis F, for the Cancer
Patient Fracture Evaluation Investigators. Balloon Kyphoplasty versus Non-surgical Fracture Management for Treatment of Painful
Vertebral Body Compression Fractures in Patients with Cancer: A Multicentre, Randomised Controlled Trial. Lancet Oncol.
Published Online February 17, 2011.