Medtronic 2009 Annual Report Download - page 31

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Medtronic, Inc.
2008. The Mosaic and Mosaic Ultra tissue valves incorporate
several design features to facilitate implantation and improve
durability. The Melody Transcatheter Pulmonary Valve and
Ensemble Transcatheter Delivery System provide a catheter-based
approach to pulmonic valve replacement for patients with
congenital heart defects, with the goal of reducing the invasiveness
and risk associated with pulmonic valve replacement.
Looking ahead, we expect our CardioVascular operating
segment should be impacted by the following:
• Future acceptance of Endeavor in the Japan market. Endeavor
received approval by the Japanese Ministry of Health, Labor
and Welfare in the fourth quarter of fiscal year 2009 and
was launched in May 2009. Following the launch in Japan,
Endeavor is commercially available for the treatment of
coronary artery disease in every major market in the world.
• Continued acceptance of Endeavor Resolute in markets
outside the U.S. Endeavor Resolute combines the proven drug
and stent components of Endeavor with Biolinx, a proprietary
biocompatible polymer specifically engineered for drug-
eluting stent use. Biolinx facilitates the slower absorption of
Zotarolimus while providing excellent biocompatibility. The
design goal of Endeavor Resolute is enhanced safety and
efficacy in the most complex lesions and patients.
• Further acceptance in the U.S. of the Talent AAA Stent Graft
System. The Talent AAA Stent Graft System received FDA
approval in April 2008 and was launched in the first quarter
of fiscal year 2009. Additionally, we anticipate further growth
in the U.S. and in Japan from the Talent Thoracic Stent Graft
System, which was initially released in the first quarter and
fourth quarter of fiscal year 2009, respectively.
• Sales growth outside the U.S. with continued acceptance of
our next generation Endurant AAA stent graft and Valiant
Thoracic Stent Graft System. The Endurant AAA stent graft
received CE Mark approval and was commercially launched
late in the first quarter of fiscal year 2009.
• The integration of Ventor Technologies Ltd. (Ventor) and
CoreValve, Inc. (CoreValve) into our CardioVascular business. In
the fourth quarter of fiscal year 2009, we acquired Ventor and
CoreValve. Both Ventor and CoreValve are medical technology
companies that develop transcatheter heart valve technologies
for replacement of the aortic valve. CoreValve’s Percutaneous
Revalving System has received CE Mark approval and is
currently available outside the U.S., while Ventor is a
development stage company and does not yet have a product
commercially available. We expect these acquisitions will
allow us to pursue opportunities that have natural synergies
with our existing heart valve franchise and leverage our
global footprint. See Note 4 to the consolidated financial
statements for additional information.
Neuromodulation Neuromodulation products consist of
therapeutic and diagnostic devices, including implantable
neurostimulation systems, implantable drug delivery devices and
urology and gastroenterology products. Neuromodulation net
sales for fiscal year 2009 were $1.434 billion, an increase of
9 percent when compared to the prior fiscal year. Foreign
currency translation had an unfavorable impact on net sales
of approximately $10 million when compared to the prior
fiscal year.
Neuro Implantables is comprised of two product lines: Pain
Management and Movement Disorders. Net sales from Pain
Management and Movement Disorders products for fiscal year
2009 were $1.145 billion, an increase of 7 percent when compared
to the prior fiscal year. The growth was driven by sales of products
in Pain Management including worldwide sales of the
RestoreULTRA neurostimulation system for pain management and
sales in the U.S. of our Specify 5-6-5 surgical lead for spinal cord
stimulation. RestoreULTRA, which was launched in March 2008, is
our next generation rechargeable neurostimulator with advanced
programming capabilities and is the thinnest 16-electrode
neurostimulator on the market. Additionally, revenue growth was
negatively impacted by the launch of a competitive product and
a short-term supply shortfall with our implantable pumps during
the fiscal year. Movement Disorders revenue was driven by
worldwide net sales of Activa Deep Brain Stimulation (DBS)
Therapy. Activa DBS Therapy is used for the treatment of common
movement disorders including Parkinson’s disease, essential
tremor and dystonia.
Net sales of Gastroenterology and Urology products for fiscal
year 2009 were $289 million, an increase of 19 percent when
compared to the prior fiscal year. The growth in Gastroenterology
and Urology was led by worldwide sales of our InterStim II
product.
Neuromodulation net sales for fiscal year 2008 increased 11
percent from the prior fiscal year to $1.311 billion. Foreign currency
translation had a favorable impact of $32 million on net sales
when compared to the prior fiscal year. In the third quarter of
fiscal year 2007, we divested our Urology diagnostics product line