Medtronic 2008 Annual Report Download - page 30

countries. We also recognized net sales of $292 million in fiscal year
2008 from the Driver family of bare metal stents, which experienced
strong growth in the U.S. as a result of reduced penetration of drug-
eluting stents in the U.S. marketplace. The Driver bare metal stent,
which is also the base stent used in Endeavor and Endeavor Resolute,
is a cobalt-chromium coronary stent which has thinner struts and
provides greater maneuverability in placing the stent.
Endovascular fiscal year 2008 net sales grew 10 percent when
compared to the prior fiscal year. Growth in the Endovascular business
was driven in part by net sales of the Talent AAA Stent Graft System and
the Valiant Thoracic Stent Graft System outside the U.S. The Valiant
Thoracic Stent Graft System is a next-generation stent graft used for the
minimally invasive repair of the thoracic aorta, the body’s largest artery,
for several disease states including aneurysms, penetrating ulcers,
acute or chronic dissections and contained or traumatic ruptures. Net
sales in the U.S. decreased in fiscal year 2008 as compared to the prior
fiscal year as a result of a voluntary field action on the AneuRx
AAAdvantage Stent Graft System that required physician and patient
notification of a product packaging issue. As of the end of the fiscal year,
both of these issues have been corrected and we expect to return to
growth in the U.S. market.
Revascularization and Surgical Therapies net sales for fiscal year 2008
were $431 million, an increase of 3 percent in comparison to the prior
fiscal year. The increase is the result of net sales growth outside the U.S.,
which increased 13 percent primarily from sales of our cannulae and
beating heart products. The strong growth outside the U.S. was partially
offset by a decrease in net sales in the U.S.
Structural Heart Disease net sales grew 3 percent in comparison to
the prior fiscal year to $297 million. The increase in net sales for the fiscal
year was driven by net sales outside the U.S., which offset slightly
negative growth in the U.S. Net sales growth outside the U.S. was driven
by sales of our Mosaic and Mosaic Ultra tissue values and our Melody
Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery
System. The growth outside the U.S. was tempered by the suspension
of sales of the Advantage mechanical heart valve in the first quarter of
fiscal year 2008. The Advantage valve was reintroduced to the market
during the third quarter of fiscal year 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.
CardioVascular net sales for fiscal year 2007 increased 19 percent from
the prior fiscal year to $1.909 billion. Foreign currency translation had a
favorable impact of $43 million on net sales when compared to the
prior fiscal year.
Coronary Stent and Other Coronary/Peripheral net sales for fiscal year
2007 increased 31 percent in comparison to the prior fiscal year to
$946 million. The growth in Coronary Stent and Other Coronary/
Peripheral net sales was primarily a result of the commercial availability
of Endeavor outside the U.S. for a full fiscal year and further acceptance
of the Driver family of bare metal stents. Endeavor, which generated
revenue of $300 million in fiscal year 2007, was then commercially
released in over 100 countries outside the U.S. We recognized revenue
of $260 million in fiscal year 2007 from the Driver family of bare metal
stents, which experienced strong growth in the U.S. as a result of
reduced penetration of drug-eluting stents in the U.S. marketplace.
Endovascular fiscal year 2007 net sales grew 20 percent when
compared to the prior fiscal year. Growth in the Endovascular business
was driven by the successful U.S. launch of the market-leading AneuRx
AAAdvantage Stent Graft System, which is used to treat abdominal
aortic aneurysms (AAA), and increased sales of the Valiant Thoracic
Stent Graft System outside the U.S.
Revascularization and Surgical Therapies net sales for fiscal year 2007
were $417 million, an increase of 4 percent in comparison to the prior
fiscal year, led by net sales of our cannulae and cardiopulmonary
products outside the U.S.
Structural Heart Disease net sales grew 9 percent in fiscal year 2007
in comparison to the prior fiscal year to $287 million. The increase in net
sales for the fiscal year was driven by sales of our Mosaic and Mosaic
Ultra tissue values as well as sales of the Melody Transcatheter Pulmonary
Valve and Ensemble Transcatheter Delivery System outside the U.S.
Looking ahead, we expect our CardioVascular operating segment
should benefit from the following:
• Continued acceptance of Endeavor, which was launched in the U.S.
market in February 2008. Endeavor is the first new drug-eluting
stent approved for use in the U.S. market in over four years and
offers a unique and beneficial safety and efficacy profile for treating
patients with coronary artery disease. Additionally, we anticipate
receiving regulatory approval and launching Endeavor in Japan in
the second half of fiscal year 2009.
• 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
Management’s Discussion and Analysis of Financial Condition
and Results of Operations
(continued)
26 Medtronic, Inc.