Medtronic 2008 Annual Report Download - page 29

products for treating lumbar spinal stenosis. Balloon kyphoplasty, using
Kyphon instruments, is presently used primarily by spine specialists,
including orthopedic surgeons and neurosurgeons, interventional
radiologists and interventional neuroradiologists, who repair
compression fractures of the spine through minimally invasive spine
surgeries. Kyphon’s interspinous products for treating lumbar spinal
stenosis include the commercially available X-STOP IPD technology
available in both the U.S. and outside the U.S. and Aperius PercLID
available outside the U.S.
Spinal net sales for fiscal year 2007 increased by 13 percent from the
prior fiscal year to $2.417 billion, driven by solid growth across our entire
portfolio of product offerings. Foreign currency translation had a
favorable impact of $7 million on net sales when compared to the prior
fiscal year. Core Spinal net sales were $1.713 billion, a 9 percent increase
over the prior fiscal year, based on continual acceptance of our
CD HORIZON LEGACY Spinal System family of products, strong growth
in our minimal access technology platforms and an increase in dynamic
stabilization product sales outside of the U.S., led by the DIAM System.
CD HORIZON SEXTANT II, a percutaneous lumbar fixation system with
minimal access technologies that reduce procedural steps, was the
main driver of the growth in the minimal access technology portfolio.
Other revenue growth drivers in Core Spinal were CAPSTONE and
CRESCENT, and the VERTEX Max Reconstruction System which is used
to stabilize the complex junction between the flexible cervical and rigid
thoracic spine. Biologics net sales were $704 million in fiscal year 2007,
a 24 percent increase over the prior year, based on continued strong
acceptance of INFUSE Bone Graft. In the Spinal market, the trend has
been that small companies continue to increase their presence in the
U.S., putting pressure on the market.
Looking ahead, we expect our Spinal operating segment should
benefit from the following:
• Continued acceptance of our products for stabilization of the
thoracolumbar and cervical sections of the spine, including the CD
HORIZON LEGACY 5.5 and the VERTEX Max Reconstruction
System.
• Continued acceptance of the INFUSE Bone Graft for spinal fusion
and certain types of acute, open tibia fractures.
• Future launch of the extra small and double extra small INFUSE kits
for use in Spinal and oral maxillofacial procedures. We received FDA
approval to market these two smaller kit sizes in April 2008, and
they are expected to be available for clinical use in June 2008.
These smaller kits should help to continue the strong growth that
we have experienced to date by expanding the potential user
population.
• Continued growth in the acceptance of our PRESTIGE Cervical Disc
System for dynamic stabilization, which received FDA approval on
July 16, 2007 and was launched in the U.S. at the end of the first
quarter of fiscal year 2008. We continue to train surgeons in the use
of this product, and are encouraged by the steady progress we are
making with reimbursement agencies for coverage.
• Continued acceptance of our Lumbar dynamic platform of products
including the PEEK Rod System in the U.S. and the DIAM System
outside the U.S. combined with continued acceptance of Kyphon’s
X-Stop IPD system and the Aperius PercLID, for the treatment of
mild to moderate lumbar spinal stenosis.
• Continued acceptance of the Kyphon instruments for use in balloon
kyphoplasty. The acquisition of Kyphon is expected to add to the
growth of our existing Spinal business by extending our product
offerings into some of the fastest growing product segments of the
spine market, enabling us to provide physicians with a broader
range of therapies for use at all stages of the care continuum.
CardioVascular CardioVascular products consist of coronary and
peripheral stents and related delivery systems, endovascular stent graft
systems, heart valve replacement technologies and tissue ablation
systems, and open heart and coronary bypass grafting surgical products.
CardioVascular net sales for fiscal year 2008 increased 12 percent from
the prior fiscal year to $2.131 billion. Foreign currency translation had a
favorable impact of $101 million on net sales when compared to the
prior fiscal year.
Coronary Stent and Other Coronary/Peripheral net sales increased
18 percent in comparison to the prior fiscal year to $1.118 billion. The
growth in Coronary Stent and Other Coronary/Peripheral net sales was
primarily a result of the successful launch of the Endeavor drug-eluting
stent (Endeavor) in the U.S., strong sales of Endeavor and the Endeavor
Resolute drug-eluting stent (Endeavor Resolute) outside the U.S. and
continued acceptance of the Driver family of bare metal stents. Although
the market for stents and drug-eluting stents has declined, Endeavor
and Endeavor Resolute continue to benefit from favorable safety and
efficacy data, along with their ease of delivery. Endeavor, which was
commercially released in the U.S. in February 2008, generated net sales
of $81 million. Outside the U.S., Endeavor and Endeavor Resolute
generated net sales of $337 million in fiscal year 2008, an increase of
12 percent over the prior year. Endeavor Resolute received CE Mark
approval in October 2007 and is currently available in more than 100
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