Medtronic 2014 Annual Report Download - page 12

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following the intervention. Our PCI stent products include our Resolute Integrity, Resolute, and Endeavor drug-eluting stent
systems as well as our Integrity, Driver, and Micro-Driver bare metal stent systems.
The charts below set forth net sales of our Coronary products as a percentage of our total net sales for each of the last three
fiscal years:
Fiscal Year 2012
(dollars in millions)
Coronary
$1,598
All Other
$14,586
Fiscal Year 2013
(dollars in millions)
All Other
$14,817
Coronary
$1,773
Fiscal Year 2014
(dollars in millions)
10%
90%
11%
89%
All Other
$15,261
Coronary
$1,744
10%
90%
Customers and Competitors
The primary medical specialists who use our Coronary products are interventional cardiologists. Our primary competitors in the
Coronary business are Abbott Laboratories (Abbott) and Boston Scientific.
Structural Heart
The Structural Heart business offers a comprehensive line of products and therapies to treat a variety of heart valve disorders.
Our products include products for the repair and replacement of heart valves, perfusion systems, positioning and stabilization
systems for beating heart revascularization surgery, and surgical ablation products.
The following are the principal products offered by our Structural Heart business:
Transcatheter Heart Valves (TCVs). TCV technology represents a less invasive means to treat heart valve disease and is
designed to allow physicians to deliver replacement valves via a catheter through the body’s cardiovascular system, eliminating
the need to open the chest. Our TCVs include the CoreValve transfemoral aortic valve and Engager transapical aortic valves as
well as the Melody pulmonary valve. CoreValve, which is the only TCV system shown to be superior to open-heart surgery, has
received U.S. FDA approval for extreme risk patients and CE Mark approval. We received U.S. FDA approval for CoreValve in
high risk patients in June 2014. Our next-generation recapturable TCV system, CoreValve Evolut R, is currently being clinically
evaluated for CE Mark approval and is expected to begin enrolling in its U.S. IDE in the first half of fiscal year 2015. Engager
has received CE Mark approval while Melody has received CE Mark approval and U.S. FDA approval under a Humanitarian
Device Exemption (HDE).
Heart Valves. We offer a complete line of surgical valve replacement and repair products for damaged or diseased heart
valves. Our replacement products include both tissue and mechanical valves. Our replacement tissue valve product offerings
include the Mosaic bioprosthetic stented, Freestyle stentless, Hancock II stented, Enable sutureless tissue (CE Mark countries),
and 3f Biological tissue valves. Our mechanical valves include the Open Pivot valve. Our valve repair products include the
Duran Flexible and CG Future Band, CG Composite Annuloplasty Systems, Profile 3D Annuloplasty Ring, Simulus Ring
portfolio, and Tri-Ad Annuloplasty Ring.
Arrested Heart Surgery. In conventional coronary artery bypass graft procedures and heart valve surgery, the patient’s heart is
temporarily stopped, or arrested. The patient is placed on a circulatory support system that temporarily functions as the patient’s
heart and lungs and provides blood flow to the body. We offer a complete line of blood-handling products that form this
circulatory support system and maintain and monitor blood circulation and coagulation status, oxygen supply, and body
temperature during arrested heart surgery. Our Affinity Fusion oxygenation system received both CE Mark and U.S. FDA
approval and is being launched globally. Affinity Fusion incorporates numerous innovations for patient safety and ease of use.
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