Medtronic 2013 Annual Report Download - page 53

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Table of Contents
transcatheter aortic heart valve. Additionally, the acquisition and integration of ATS Medical, which was acquired in August 2010,
contributed to the net sales growth.
Endovascular net sales for fiscal year 2012 were $783 million, an increase of 18 percent over fiscal year 2011. The increase in
Endovascular net sales was primarily driven by growth outside the U.S, driven by the performance of the Endurant AAA and
Valiant Captivia Thoracic stent graft systems. Endurant AAA Stent Graft System net sales in the U.S. also contributed to the
growth.
Looking ahead, we expect our Cardiac and Vascular Group could be affected by the following:
• Increasing pricing pressures and competition.
• Fluctuations in U.S. and certain Western Europe market growth rates for our defibrillation and pacing system
products.
• Market acceptance and future growth from the Evera family of ICDs, which received CE Mark approval in
February 2013 and U.S. FDAapproval in May 2013. The Evera family of ICDs have increased battery longevity,
advanced shock reduction technology, and a contoured shape with thin, smooth edges that better fits inside the
body.
• Market acceptance and future growth from the Viva/Brava family of CRT-D devices and the Attain Performa
portfolio of quadripolar leads. The Viva/Brava family of CRT-D devices utilizes a new algorithm, called
AdaptivCRT, which improves patients’response rate to CRT-D therapy by preserving the patients’normal heart
rhythms and continually adapting to individual patient needs. Our Viva/Brava CRT-D devices received CE
Mark approval in August 2012 and U.S. FDA approval in May 2013. Paired with Medtronic Viva/Brava Quad
CRT-D, Attain Performa leads provide additional options for physicians to optimize patient therapy. Our Attain
Performa left-heart leads received CE Mark approval in March 2013.
• Continued and future growth from the Advisa DR MRI SureScan pacing system. The Advisa DR MRI SureScan
is our second-generation MRI pacing system and is the first system to combine advanced pacing technology
with proven MRI access. The Advisa DR MRI SureScan was launched in Europe during the fourth quarter of
fiscal year 2010, in the U.S. in February 2013, and in Japan, where it is the first and currently the only MRI
pacing system, in the second quarter of fiscal year 2013.
• Continued and future growth from the Arctic Front system, including the second generation Arctic Front
Advance Cardiac Cryoballoon launched in the second quarter of fiscal year 2013. The Arctic Front system is
a cryoballoon indicated in the U.S. 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 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 Japan at the end of August 2012, in the
U.S. in February 2012, and in Europe in August 2010. Also, in February 2013, the U.S. FDA approved longer
lengths of our Resolute Integrity drug-eluting coronary stent, providing access to a larger portion of the U.S.
drug-eluting stent market. We expect approval for longer lengths of our Resolute Integrity drug-eluting coronary
stent in Japan during fiscal year 2014. 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 therapies. Commercially, we are still in the pre-
reimbursement phase in many countries, and will likely remain in that phase until we obtain additional clinical
data. Our Symplicity Catheter System, which addresses uncontrolled hypertension through renal denervation,
or ablation of the nerves lining the renal arteries, has received CE Mark approval and Australia’s Therapeutic
Goods Administration listing, and was approved in Canada by the Therapeutic Products Directorate in the
fourth quarter of fiscal year 2012. This summer, we anticipate CE Mark approval for our Symplicity Spyral
multi-electrode catheter which will significantly reduce ablation time. We recently completed patient enrollment
in our U.S. pivotal study and remain on track for U.S. approval in late fiscal year 2015. Enrollment in our
Symplicity Trial in Japan is also underway.
• Continued growth in Japan from the Endurant AAA Stent Graft System, and continued growth worldwide of
the Valiant Captivia Thoracic Stent Graft System. The Endurant AAA Stent Graft System received
Pharmaceuticals and Medical Devices Agency approval and was launched in Japan during the third quarter of
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