Medtronic 2016 Annual Report Download - page 47

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2016 and launched in March 2016. The Amplia/Compia/Claria family of MRI Quad CRT-D SureScan systems
received CE Mark approval in February 2016. The systems are approved for MRI scans on any part of the body
without positioning restrictions.
• Continued 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 rates to CRT-D therapy by preserving the patients’ normal
heart rhythms and continually adapts to individual patient needs. Paired with Viva/Brava Quad CRT-D, Attain
Performa leads provide additional options for physicians to optimize patient therapy. 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. We received U.S. FDA approval of our Evera
MRI SureScan ICD in the second quarter of fiscal year 2016.
• Continued acceptance and future growth from the Advisa DR MRI SureScan pacing system for use in full-
body MRI scans. 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. We received U.S. FDA approval of
the Advisa SR MRI SureScan single-chamber pacemaker in the first quarter of fiscal year 2016.
• 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 the first quarter
of fiscal year 2016 for the Aortic Front Advance ST Cryoablation Catheter.
• Continued future growth from Reveal LINQ, our next-generation insertable cardiac monitor launched in
international and U.S. markets in the third and fourth quarters of fiscal year 2014, respectively.
• Acceptance and future growth of our Micra transcatheter pacing system, which received CE Mark approval in
April 2015 and U.S. FDA approval in April 2016. 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 acceptance and future growth from Care Management Service's remote telemonitoring solutions
business for the management of chronic diseases such as heart failure, diabetes, and hypertension. Care
Management Services has a readmission reduction program focused on minimizing heart failure readmission
penalties for U.S. hospitals.
• Continued 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. At the end of fiscal year 2016,
we had 88 long-term CLMS agreements.
• Continued acceptance of CoreValve Evolut R, our next-generation recapturable system with differentiated 14-
French equivalent delivery system. We have CE Mark approval for the 23 millimeter size of the valve and
received CE Mark approval for the 26 and 29 millimeter sizes early in the fourth quarter of fiscal year 2015.
We received U.S. FDA approval of the 23, 26, and 29 millimeter sizes in the first quarter of fiscal year 2016.
• Acceptance of our CoreValve transcatheter heart valve technologies for the replacement of the aortic valve in
Japan. We received Japanese regulatory approval in March 2015 and launched in Japan late in the third quarter
of fiscal year 2016 following reimbursement approval. We received U.S. FDA approval for valve-in-valve
implantation in March 2015.
• Acceptance of the Resolute Onyx drug-eluting coronary stent, which received CE Mark approval in November
2014. Resolute Onyx builds on the Resolute Integrity drug-eluting coronary stent with thinner struts to improve
deliverability and is the first stent to feature our CoreWire technology, allowing greater visibility during the