Medtronic 2015 Annual Report Download - page 61

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•Continued acceptance and growth of 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 in use of the ENT power systems using the newly launched M5 Microdebrider
hand piece.
•Acceptance 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.
Diabetes Group The Diabetes Group products include insulin pumps, CGM systems, insulin pump consumables, and therapy
management software. The Diabetes Group’s net sales for fiscal year 2015 were $1.762 billion, an increase of 6 percent over the
prior fiscal year. The Diabetes Group’s performance was primarily the result of 9 percent growth in the U.S. compared to the
prior fiscal year, 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 foreign currency.
The Diabetes Group’s net sales for fiscal year 2014 were $1.657 billion, an increase of 9 percent over the prior fiscal year. The
increase in net sales was driven by U.S sales of the MiniMed 530G System with Enlite Sensor, as well as $23 million of revenue
recognized that was deferred in fiscal year 2013 as some customers upgraded to the MiniMed 530G System after it was released
in the U.S. Net sales in the international markets increased 9 percent compared to the prior fiscal year. Performance in
international markets was favorably affected by the continued adoption and use of the Veo insulin pump with low-glucose
suspend and Enlite CGM sensor.
Looking ahead, we expect our Diabetes Group could be impacted by the following:
•Potential risk of pricing pressures, reduction in reimbursement rates, and fluctuations in foreign currency.
•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 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.
•Acceptance and future growth from our next-generation pump systems, the MiniMed 640G and MiniMed 620G.
Internationally, we began a launch of our MiniMed 640G pump system with predictive low-glucose management
in Australia and Europe. We continue to make progress in bringing this technology to the U.S. and plan to submit
the pre-market approval for this system during calendar year 2015. In the fourth quarter of fiscal year 2015, we
also began a full market release in Japan of the MiniMed 620G system, the first integrated system customized for
the Japanese market.
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