Medtronic 2009 Annual Report Download - page 30

26 Medtronic, Inc.
Management’s Discussion and Analysis of Financial Condition
and Results of Operations
(continued)
and the Endeavor Resolute drug-eluting stent (Endeavor Resolute)
generated worldwide revenue of $603 million for the fiscal year
compared to $418 million for the prior year.
Endovascular net sales for fiscal year 2009 were $398 million, an
increase of 40 percent when compared to the prior fiscal year.
Growth in the Endovascular business was primarily driven by net
sales in the U.S. of the Talent Abdominal Aortic Aneurysm Stent
Graft System (Talent AAA Stent Graft System) and Thoracic
Stent Graft System and by the launch of our Endurant Abdominal
Stent Graft System outside the U.S. in the first quarter of fiscal
year 2009. The Endurant Abdominal Stent System expands the
applicability of endovascular aortic repair to more patients with
abdominal aortic aneurysms (AAA) by addressing those AAA
patients whose aortas are highly angulated or whose aneurysms
have short necks.
Revascularization and Surgical Therapies net sales for fiscal year
2009 were $447 million, an increase of 4 percent when compared
to the prior fiscal year. The increase was primarily the result of
positive growth outside the U.S. associated with our cannulae and
beating heart products.
Structural Heart Disease net sales for fiscal year 2009 were $300
million, an increase of 1 percent when compared to the prior
fiscal year. The increase was primarily the result of net sales
growth outside the U.S. which benefited from the return of the
Advantage Mechanical Valve to markets from which it had been
suspended for a portion of the prior fiscal year. Net sales of our
atrial fibrillation technologies outside the U.S. also contributed to
the increase in net sales for fiscal year 2009. Growth outside the
U.S. was partially offset by a decrease in net sales in the U.S. due
to the entrance of three new competitive tissue valve products
into the market during the past twelve months.
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 for
fiscal year 2008 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 Endeavor in the U.S., strong sales of Endeavor
and 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 had declined, Endeavor and
Endeavor Resolute continued to benefit from favorable safety and
efficacy data, along with their ease of delivery. In the U.S.,
Endeavor generated net sales of $81 million in fiscal year 2008.
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
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 net sales for fiscal year 2008 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 fiscal year 2008, the issue had been corrected.
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 for fiscal year 2008 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