Medtronic 2014 Annual Report Download - page 10

Our primary customers include hospitals, clinics, third-party health care providers, distributors, and other institutions, including
governmental health care programs and group purchasing organizations.
CARDIAC AND VASCULAR GROUP
Cardiac Rhythm Disease Management
CRDM develops, manufactures, and markets products for the diagnosis, treatment, and management of heart rhythm disorders
and heart failure, including implantable devices, leads and delivery systems, products for the treatment of atrial fibrillation (AF),
products designed to reduce surgical site infections, information systems for the management of patients with CRDM devices,
and an integrated health solutions business.
The following are the principal products offered by our CRDM business:
Implantable Cardiac Pacemakers (Pacemakers). A pacemaker is a battery-powered device implanted in the chest that
delivers electrical impulses to treat bradycardia, a condition of abnormally slow heart rhythms, usually less than 60 beats per
minute, or unsteady heart rhythms that cause symptoms such as dizziness, fainting, fatigue, and shortness of breath. Our latest
generation of pacemaker systems is compatible with certain magnetic resonance imaging (MRI) machines. These include the
Advisa and Revo MRI SureScan models, which have received United States (U.S.) Food and Drug Administration (U.S. FDA)
approval, and the Advisa and Ensura MRI SureScan models which have received Conformité Européene (CE) Mark approval.
We also continue to market the Adapta product family, which includes the Adapta, Versa, and Sensia models.
Implantable Cardioverter Defibrillators (ICDs). An ICD continually monitors the heart and delivers therapy when an
abnormal heart rhythm, such as tachyarrhythmia, or rapid heart rhythm, occurs and leads to sudden cardiac arrest. Our latest
generation ICD is the Evera MRI SureScan, the first and only ICD system with CE Mark approval for full-body MRI scans
which has increased battery longevity, advanced shock reduction technology, and a contoured shape with thin, smooth, edges
that better fits inside the body. The Evera system is paired with the reliable Sprint Quattro Secure lead, the only defibrillator
lead with more than 10 years of proven performance with active monitoring. In addition to Evera, devices in the ICD family
include the Protecta XT/Protecta with SmartShock technology, including the Lead Integrity Alert (LIA), an exclusive
technology designed to improve the detection of lead fractures, and the Cardia and Egida models. We also continue to market
the Secura, Virtuoso, and Maximo II devices.
Implantable Cardiac Resynchronization Therapy Devices (CRT-Ds and CRT-Ps). Implantable cardiac resynchronization
therapy (CRT) devices are combined with defibrillation (CRT-D) or are pacing-only (CRT-P). These devices treat heart failure
patients by altering the abnormal electrical sequence of cardiac contractions by sending tiny electrical impulses to the lower
chambers of the heart to help them beat in a more synchronized fashion. Our latest generation of CRT-Ds is the Viva/Brava
family that features a new algorithm, called AdaptivCRT, which improves heart failure patients’ response rate to CRT-D
therapy, as compared to historical CRT trials, by preserving the patients’ normal heart rhythms and continuously adapting to
individual patient needs. Other features of the Viva/Brava portfolio include Ensure CRT, which works to maximize CRT
treatment, even during atrial fibrillation, SmartShock technology, increased battery longevity, and OptiVol 2.0 fluid status
monitoring. In Europe, we also have CE Mark approval for our Attain Performa quadripolar leads. Paired with our Viva/Brava
Quad CRT-Ds, Attain Performa left-heart leads provide additional options for physicians as they navigate different patient
anatomies, optimizing therapy based on the individual needs of heart failure patients. Our quadripolar technology is in the
clinical evaluation process for U.S. FDA approval. Our CRT-D devices also include the Protecta XT/Protecta with SmartShock
technology. With respect to CRT-P, we recently received CE Mark approval for our Viva CRT-P, which includes the
AdaptivCRT software. In the U.S., our latest CRT-P devices are Consulta and Syncra.
AF Products. AF is a condition in which the atrium quivers instead of pumping blood effectively. Our portfolio of AF
products includes the Arctic Front Advance Cardiac Cryoballoon System designed for pulmonary vein isolation in the treatment
of patients with drug refractory paroxysmal AF. Additionally, we have a second-generation CE Mark approved Phased RF
System, PVAC Gold, which uses duty cycled, phased radio frequency energy for the treatment of symptomatic paroxysmal
persistent and long-standing persistent AF. Our Phased RF portfolio, including PVAC Gold, is currently being clinically
evaluated by the U.S. FDA.
Diagnostics and Monitoring Devices. The Reveal LINQ is our newest Insertable Cardiac Monitor (ICM) System, having
recently received U.S. FDA and CE Mark approval. The system is used to record the heart’s electrical activity before, during,
and after transient symptoms such as syncope (i.e., fainting) and palpitations to help provide a diagnosis and is the smallest ICM
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