Medtronic 2011 Annual Report Download - page 32

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28 Medtronic, Inc.
Management’s Discussion and Analysis of Financial Condition
and Results of Operations
(continued)
• Market acceptance of new high pressure BKP balloons
and syringes, curettes, and fixation materials in the Spinal
business, which were launched during the second quarter of
fiscal year 2011. In the fourth quarter of fiscal year 2010, we
received regulatory clearance in Japan for BKP. Subsequent
to receiving reimbursement approval, BKP was launched in
Japan during the third quarter of fiscal year 2011. We expect
a positive impact over time from the improvement in certain
international markets, such as Japan. Market growth potential
in Japan will be dependent upon additional investment and
development of the market.
Additionally, we remain focused on generating evidence
to support the clinical and economic benefits for BKP. In
February 2011, results from three BKP clinical studies were
published, which continue to build the body of clinical
evidence demonstrating the benefits of BKP over other
surgical and non-surgical treatment options.
• Increased presence in China as a result of our joint venture
with Weigao to distribute Medtronic’s spinal products and
Weigao’s orthopedic products in China.
• Expected future growth in our Biologics business, driven by
new products and by our acquisition of Osteotech, which
closed in the third quarter of fiscal year 2011. Osteotech
develops innovative biologic products for regenerative
healing.
• We continue to seek the FDA’s approval to market our new
bone graft product, AMPLIFY rhBMP-2 Matrix (AMPLIFY) for
single-level, posterolateral spinal fusion procedures in
patients with degenerative disc disease. In the third quarter
of fiscal year 2011, the FDA sent us a letter advising that the
FDA was not able to approve AMPLIFY at that time without
additional information from us. We remain in active dialogue
with the FDA to address the issues in its letter and are hopeful
that the FDA will ultimately approve AMPLIFY.
• Any effects on our business from discussions in the medical
literature, or inquiries from governmental authorities, relating
to our INFUSE Bone Graft product. In June 2011, articles in
a medical journal suggested that some physicians’ peer-
reviewed studies may have underreported complications and
adverse events associated with INFUSE. These articles did not
question the integrity of the data provided by Medtronic
to the FDA for product approval or the disclosure of safety
issues on the products’ Instructions for Use for approved
indications.
• Ability to consistently grow within the pain management
market, which is characterized by significant competition. We
remain focused on a number of key initiatives in the areas of
product development and sales execution as well as therapy
adoption growth, which we expect will sustain our market
leadership.
• Continued and future acceptance of our current indications
for Medtronic DBS Therapy for the treatment of movement
disorders, Epilepsy (approved in Europe) and OCD. The DBS
Therapy portfolio includes Activa PC, our small and advanced
primary cell battery, and Activa RC, a rechargeable DBS
device. Additionally, Activa SC was approved in the U.S. and
Europe in fiscal year 2011.
• Continued acceptance of InterStim Therapy for the treatment
of the symptoms of overactive bladder and urinary retention.
InterStim Therapy for Bowel Control is also approved in
Europe. InterStim Therapy for Bowel Control was approved by
the FDA in the fourth quarter of fiscal year 2011 and launched
in the first quarter of fiscal year 2012. Approximately 18
million patients suffer from fecal incontinence in the U.S.,
and very few treatment options exist for this condition.
• Continued acceptance of the RestoreSensor, which was
launched in Europe during the fourth quarter of fiscal year
2010. In the U.S., a clinical trial was completed to support
submission for FDA approval. Additionally, RestoreSensor
was launched in Canada and Australia during fiscal year
2011. RestoreSensor is an innovative spinal cord stimulator
featuring our exclusive AdaptiveStim technology, which
addresses the need for spinal cord stimulation patients
through automatically adapting stimulation to changes in
body position and activity, and minimizes the need for
manual stimulation adjustments.
• Continued acceptance from both physicians and patients
of insulin-pump therapy and CGM therapy and continued
acceptance and improved reimbursement of CGM
technologies. Additionally, the Enlite sensor was launched in
certain international markets in the fourth quarter of fiscal
year 2011.
• Continued acceptance of new insulin pumps, including Veo,
which offers low-glucose suspend that assists in protecting
against the risk of hypoglycemia by automatically suspending
insulin delivery when glucose falls below a specified threshold
set by the user. Veo was launched throughout Asia and