Medtronic 2016 Annual Report Download - page 52

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PC, our small and advanced primary cell battery, and Activa RC, a rechargeable DBS device. We anticipate
continued competitive pressures in Europe and expect competition to enter the U.S. market in the coming year.
• Continued acceptance of InterStim Therapy for the treatment of the symptoms of overactive bladder, urinary
retention, and bowel incontinence.
• Continued acceptance and growth of our Surgical Technologies therapies, including Advanced Energy products
and strategies to focus on its four core markets of orthopedic, spine, breast surgery, and CRDM replacements,
Neurosurgery StealthStation S7 and O-Arm Imaging Systems, Midas and ENT power systems, and
intraoperative nerve monitoring during surgical procedures utilizing the NIM-Response 3.0 during head and
neck surgical procedures. Additionally, continued growth in nerve monitoring utilizing the NIM Eclipse system
during spinal surgical procedures.
• Acceptance of the recently launched NuVent sinus balloon, with built-in surgical EM navigation, used for
chronic sinusitis to restore sinus drainage in a minimally invasive way.
• Continued acceptance and growth of Neurovascular therapies, including the Solitare FR revascularization
device for treatment of acute ischemic stroke and the Pipeline Embolization Devices, endovascular treatments
for large or giant wide-necked brain aneurysms.
• Future acceptance of the Medina mesh coil implant launched in European Union in May 2016. Medina Medical
was acquired in August 2015 and focuses on the commercialization of treatments for vascular abnormalities
of the brain, including cerebral aneurysms.
• Efficiencies gained from fiscal year 2017 reorganization to provide a stronger focus on the diseases and
conditions that we serve to further innovate, integrate platforms and leverage breadth of product portfolio across
Restorative Therapies Group. Beginning in the first quarter of fiscal year 2017, the new reporting structure
includes Spine, Brain Therapies (consists of Modulation, Neurovascular, and Neurosurgery), Pain Therapies
(consists of Stimulation, Pump, and Interventional), and Specialty Therapies (consists of Pelvic Health,
Advanced Energy, and ENT).
Diabetes Group The Diabetes Group is composed of the Intensive Insulin Management (IIM), Non-Intensive Diabetes Therapies
(NDT) and Diabetes Service & Solutions (DSS) divisions. The Diabetes Group products include insulin pumps, continuous glucose
monitoring (CGM) systems, insulin pump consumables, and therapy management software. The Diabetes Group’s net sales for
fiscal year 2016 were $1.9 billion, an increase of 6 percent over the prior fiscal year, and were favorably affected by an additional
selling week during the first quarter of fiscal year 2016. Net sales in the U.S. increased 6 percent compared to the prior fiscal year,
driven by the MiniMed 530G System with Enlite sensor in the IIM division. Currency translation had an unfavorable impact on
net sales of $101 million as a result of the change in exchange rates from the prior year. The Diabetes Group's performance in
international markets was favorably affected by our next-generation MiniMed 640G System with the Enhanced Enlite sensor.
The Diabetes Group’s net sales for fiscal year 2015 were $1.8 billion, an increase of 6 percent over the prior fiscal year. The
increase in net sales was primarily driven by 9 percent growth in the U.S., driven by the ongoing launch of the MiniMed 530G
System with Enlite Sensor. Approval was obtained late in the second quarter of fiscal year 2014. Net sales in the international
markets increased 2 percent compared to the prior fiscal year. Performance in international markets was favorably affected by the
launch of our next-generation MiniMed 640G System with the Enhanced Enlite CGM sensor in Australia and Europe, partially
offset by unfavorable currency translation.
Looking ahead, we expect our Diabetes Group could be impacted by the following:
• Increasing competition, potential risk of pricing pressures, reduction in reimbursement rates, and fluctuations
in currency exchange rates.
• Changes in medical reimbursement policies and programs. Continued acceptance and improved reimbursement
of CGM technologies.
• Continued acceptance from both physicians and patients of insulin-pump and CGM therapy.
• Continued acceptance and future growth of the MiniMed 530G System, available in the U.S., which includes
the insulin pump and Enlite sensor. This is the first system in the U.S. that assists in protecting against the risk
of hypoglycemia by automatically suspending insulin delivery when glucose falls below a specified threshold.
• Continued acceptance and future growth from our next-generation pump systems, the MiniMed 640G with
SmartGuard predictive low-glucose management, which has launched in Europe, Australia, and select Latin