Medtronic 2012 Annual Report Download - page 53

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launch of the Revo MRI SureScan pacing system. The decline in worldwide net sales of our defibrillation
and pacing system products was partially offset by worldwide net sales growth of our other products,
primarily the U.S. launch of the Arctic Front system in the third quarter of fiscal year 2011 and strong AF
Solutions growth in certain international markets.
CardioVascular net sales for fiscal year 2011 were $3.109 billion, an increase of 9 percent over the prior
fiscal year. The increase in CardioVascular net sales was primarily due to growth outside the U.S. in our
Coronary, Structural Heart, and Endovascular and Peripheral businesses. The primary contributors to net
sales growth were driven by new product introductions including the Resolute drug-eluting stent and our
Integrity bare metal stent within Coronary, the Endurant Abdominal and Valiant Captivia Thoracic Stent
Graft System within Endovascular and Peripheral, as well as the recent launch in the U.S. of the Endurant
Abdominal Stent Graft System, and the continued acceptance outside the U.S. of our CoreValve
transcatheter valve within Structural Heart. Additionally, the acquisitions of ATS Medical and Invatec
contributed to the overall growth in net sales of the CardioVascular business.
Looking ahead, we expect our Cardiac and Vascular Group could be impacted by the following:
• The slowdown in certain market growth rates. Our performance in the Cardiac and Vascular Group
has been and will continue to be affected by continued market growth rates and our ability to
increase or maintain our market position. The current Cardiac and Vascular Group market is
impacted by increasing pricing pressures, competition, and slowing procedure growth.
• Fluctuations in market growth rates for our U.S. defibrillation system products throughout fiscal
year 2012. We believe the U.S. market was impacted in fiscal year 2012 by the ICD utilization
article in the January 2011 Journal of the American Medical Association, the hospital utilization
investigation by the DOJ, and the continued trend of increased hospital ownership of physician
practices. In the fourth quarter of fiscal year 2012, we began to see signs of stabilization.
• Continued market acceptance of our Protecta family of devices, which was launched in the U.S. in
the fourth quarter of fiscal year 2011. The Protecta portfolio leverages the already established
Vision 3D platform to deliver a full suite of single, dual, and triple chamber defibrillators that
include SmartShock Technology, a family of new Medtronic-exclusive algorithms that reduces the
delivery of inappropriate shocks, which is a leading clinical request from physicians.
• Continued and future growth of the first pacing system developed specifically for use in MRI
machines. During the fourth quarter of fiscal year 2010, we launched Advisa MRI SureScan, our
next generation MRI pacing system in Europe and, early in the fourth quarter of fiscal year 2011,
we received U.S. FDA approval for the Revo MRI SureScan, our first generation MRI pacing
system in the U.S. Both Advisa MRI SureScan and Revo MRI SureScan are designed to address
and mitigate interactions between the pacing system and the magnetic resonance imaging
environment. We believe that these MRI compatible products will continue to protect recent share
gains and help alleviate pricing pressures.
• Continued and future growth from the Arctic Front system. The Arctic Front system is a
cryoballoon indicated for the treatment of drug refractory paroxysmal atrial fibrillation. The
cryoballoon treatment involves a minimally invasive procedure that efficiently creates
circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals
that cause irregular heartbeat.
• Continued and future acceptance of the Resolute Integrity drug-eluting coronary stent and the
Integrity bare metal stent. The Resolute Integrity drug-eluting coronary stent was launched in the
U.S. in February 2012, Europe in August 2010, and we expect to launch in Japan during the second
half of fiscal year 2013. The Integrity platform features a laser-fused sinusoidal technology that is
designed to significantly improve flexibility and conformability compared to the Driver stent and
other technologies. While the global stent market continues to experience year-over-year declines,
to date we have been successful in gaining share with this stent platform in those geographies
where the product has been approved.
• Continued and future acceptance of renal denervation. Our Symplicity Catheter System addresses
uncontrolled hypertension through renal denervation, or ablation of the nerves lining the renal
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