Medtronic 2015 Annual Report Download - page 56

normal heart rhythms and continually adapts to individual patient needs. Our Viva/Brava CRT-D devices
received CE Mark approval in August 2012, received U.S. FDA approval in May 2013, and launched in Japan
in the third quarter of fiscal year 2014. Paired with Viva/Brava Quad CRT-D, Attain Performa leads provide
additional options for physicians to optimize patient therapy. Our Attain Performa quadripolar lead system
received CE Mark approval in March 2013 and launched in Japan in the third quarter of fiscal year 2014. In
the second quarter of fiscal year 2015, we received U.S. FDA approval of our Attain Performa quadripolar
lead, Viva Quad XT CRT-D, and Viva Quad S CRT-D.
•Continued acceptance and future growth from the Evera family of ICDs. The Evera family of ICDs has
increased battery longevity, advanced shock reduction technology, and a contoured shape with thin, smooth
edges that better fits inside the body. Our Evera MRI SureScan ICD received CE Mark approval late in the
fourth quarter of fiscal year 2014 and launched in Japan in November 2014. U.S. launch is expected in fiscal
year 2016.
•Continued acceptance 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. In the third quarter of fiscal year 2014, we received expanded
labeling for full-body MRI scans from the U.S. FDA.
•Acceptance of our Micra transcatheter pacing system, which received CE Mark approval in April 2015. Micra
is a miniaturized single chamber pacemaker system that is delivered through the femoral vein and is implanted
in the right ventricle of the heart. The system does not use a lead and does not have a subcutaneous device
pocket underneath the skin as with conventional pacemaker systems.
•Continued future growth from the Arctic Front system, including the second generation Arctic Front Advance
Cardiac Cryoballoon. 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 studies have indicated is the
source of erratic electrical signals that cause irregular heartbeat. We received U.S. FDA approval in May 2015
for the Arctic Front Advance ST Cryoablation Catheter.
•Continued and future growth from TYRX’s proprietary anti-infection envelope technology to reduce
infections that may result from device implants. Currently, we are leveraging this technology in the Cardiac
Rhythm & Heart Failure division, and ultimately we intend to leverage this technology in other divisions such
as Neuromodulation.
•Integration of Corventis into the Cardiac and Vascular Group. Corventis was acquired in June 2014.
•Continued acceptance and future growth from Cardiocom’s remote telemonitoring solutions business for the
management of chronic diseases such as heart failure, diabetes, and hypertension. Cardiocom has a
readmission reduction program focused on minimizing heart failure readmission penalties for U.S. hospitals.
•Acceptance of our CLMS business. CLMS provides a unique service offering, whereby we enter into long-
term contracts with hospitals, both within Europe and in certain other regions around the world, to upgrade
and more effectively manage their cath lab and hybrid operating rooms. As of the end of fiscal year 2015, we
had fifty agreements. We expect net sales trends to also be impacted by the integration of NGC into the CLMS
business. NGC brings expertise in material management and managed equipment services, infrastructure
design, and turnkey installation. NGC was acquired in August 2014.
•Continued acceptance of our CoreValve transcatheter heart valve technologies for the replacement of the
aortic valve. We received U.S. FDA approval for our CoreValve transcatheter aortic heart valve for extreme
risk patients in the U.S in the third quarter of fiscal year 2014. We received U.S. FDA approval for high risk
patients in June 2014. We continue to add new sites, with a presence now in over 275 U.S. sites. We received
U.S. FDA approval for valve-in-valve implantation in March 2015.
•Continued international acceptance of CoreValve Evolut R, our next-generation self-expanding valve with
differentiated 14-French equivalent delivery system. We have received CE Mark approval for the 26 and 29
millimeter sizes of the valves in the fourth quarter of fiscal year 2015.
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