Medtronic 2010 Annual Report Download - page 30

26 Medtronic, Inc.
Management’s Discussion and Analysis of Financial Condition
and Results of Operations
(continued)
was recorded in the first quarter of fiscal year 2010 related to
inventory previously sold to the distributor.
Endovascular net sales for fiscal year 2010 were $495 million, an
increase of 24 percent when compared to the prior fiscal year.
The increase in net sales was primarily the result of increased
sales in the U.S. of the Talent Abdominal Aortic Aneurysm Stent
Graft System and Thoracic Stent Graft System and the Endurant
Abdominal Stent Graft System outside the U.S. The Endurant
Abdominal Stent Graft 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. The Endurant Abdominal Stent Graft System
also enables treatment of patients with small or tortuous iliac
arteries due to lower crossing profile of the delivery system.
Structural Heart net sales for fiscal year 2010 were $880 million,
an increase of 18 percent when compared to the prior fiscal year.
The increase was primarily the result of net sales growth outside
the U.S. from our CoreValve transcatheter valve, tissue surgical
valves and cannulae products.
CardioVascular net sales for fiscal year 2009 were $2.437 billion,
an increase of 14 percent when compared to the prior fiscal year.
Foreign currency translation had an unfavorable impact on net
sales of approximately $23 million when compared to the prior
fiscal year.
Coronary net sales for fiscal year 2009 were $1.292 billion, an
increase of 16 percent when compared to the prior fiscal year. The
growth in Coronary net sales was primarily a result of the launch
of Endeavor in the U.S., which began during fiscal year 2008. We
received regulatory approval in Japan during the fourth quarter
of fiscal year 2009 and commercially launched Endeavor in Japan
in May 2009. Endeavor and Resolute generated worldwide
revenue of $603 million for the fiscal year 2009 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.
The growth in Endovascular was primarily driven by net sales in
the U.S. of the Talent Abdominal Aortic Aneurysm 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.
Structural Heart net sales for fiscal year 2009 were $747 million,
an increase of 3 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, our surgical ablation and
from our cannulae and beating heart products. 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 in the market during the fiscal year.
Looking ahead, we expect our CardioVascular operating
segment should be impacted by the following:
• Continued acceptance of Endeavor in the Japan market.
Endeavor was launched in Japan in the first quarter of fiscal
year 2010. We anticipate increased competition in the Japan
marketplace as a result of two competitive products that
were launched in the fourth quarter of fiscal year 2010.
• Continued acceptance of Resolute in markets outside the U.S.
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 elution of Zotarolimus while providing
excellent biocompatibility. Resolute demonstrated similar
one-year rates of cardiac death, heart attacks related to the
treated vessel and the need for repeat procedures in the
same location in a large randomized trial compared to our
competitor’s market leading drug eluting stent in unselected,
complex patients.
• Launch of new Integrity bare metal stent and Resolute
Integrity coronary stent in certain international markets. The
Integrity platform features a unique laser fused sinusoidal
technology that is designed to significantly improve flexibility
and conform ability to Driver and other technologies.
• Further growth in the U.S. and Japan from the Talent Thoracic
Stent Graft System, which was initially released in fiscal year
2009 and the first quarter of fiscal year 2010, respectively. In
addition, we expect to launch our Talent Abdominal Aortic
Aneurysm Stent Graft System and improved delivery system,
Xcelerant, for our Thoracic Stent Graft System in Japan and an
improved delivery system, Captivia, for our Thoracic Stent Graft
System in the U.S.; all in the second half of fiscal year 2011.
• Sales growth outside the U.S. with continued acceptance of
our next generation Endurant Abdominal Stent Graft System
and the launch of our Valiant Thoracic Stent Graft System on
the recently released Captivia delivery system. Valiant Captivia
received CE Mark approval and was commercially launched in
the second quarter of fiscal year 2010, and the Endurant
Abdominal Stent Graft System was commercially launched in
fiscal year 2009.