SEC Filings

MEDTRONIC PLC filed this Form 10-Q on 09/01/2017
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Continued acceptance and adoption rates of stimulators and leads approved to treat chronic pain in major markets around the world.
Ongoing obligations under the U.S. FDA consent decree entered in April 2015 relating to the SynchroMed drug infusion system and the Neuromodulation quality system.
Continued and future acceptance of our current indications for Medtronic DBS Therapy for the treatment of movement disorders and epilepsy (approved in Europe). We anticipate continued competitive pressures in Europe and the U.S.
Continued acceptance and growth of our Specialty Therapies, including InterStim therapy for the treatment of the symptoms of overactive bladder, urinary retention, and bowel incontinence, and Transformative Solutions products and strategies to focus on its four core markets of orthopedic, spine, breast surgery, and Cardiac Rhythm Disease Management device replacements.
Continued growth from Neurosurgery StealthStation and O-Arm Imaging Systems, Midas and ENT power systems.
Continued acceptance and growth of 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.
Continued successful placement of robotic units and associated market adoption of robot-assisted spine procedures, under an exclusive worldwide distributor agreement with Mazor Robotics.
Diabetes Group
The Diabetes Group's products include insulin pumps, continuous glucose monitoring (CGM) systems, insulin pump consumables, and therapy management software. The Diabetes Group’s net sales for the three months ended July 28, 2017 were $449 million, a decrease of 1 percent as compared to the three months ended July 29, 2016. The Diabetes Group's net sales declined for the three months ended July 28, 2017, primarily as a result of a decline in sales in the U.S. due to ongoing sensor supply constraints, partially offset by growth in international markets due to strong sales in Europe and Asia Pacific of the MiniMed 640G system. In the U.S., we continue to experience strong consumer demand and acceptance of our revolutionary 670G hybrid closed loop system, with Guardian Sensor3 CGM.
Looking ahead, we expect our Diabetes Group could be affected by the following:
Competitive and pricing pressure, reimbursement challenges, impacts from changes in the mix of our product offerings, the timing of product registration approvals, and fluctuations in currency exchange rates.
Continued sensor supply constraints, along with higher than expected demand, will impact production as we prioritize fulfillment against our installed base of patients first. We expect new sensor manufacturing lines to be ready for commercial production by the fourth quarter of fiscal year 2018, at which time we expect to have the capacity needed to meet the rapidly growing sensor demand.
Acceptance and future growth of the MiniMed 670G system, the first hybrid closed loop system in the world. The system features our most advanced SmartGuard HCL algorithm, which enables improved glucose control with reduced user input. The MiniMed 670G system received U.S. FDA approval during the second quarter of fiscal year 2017 and launched in the U.S. in June 2017. The sensor supply constraint described above will delay the growth acceleration of the 670G system into the fourth quarter of fiscal year 2018.
Changes in medical reimbursement policies and programs, along with payor coverage of the MiniMed 670G system.
Acceptance of the MiniMed 630G system, which includes the insulin pump and Enlite CGM sensor. This system launched in the U.S. in fiscal year 2017 and combines proprietary SmartGuard technology featured in the MiniMed 530G system with a brand new hardware platform and user-friendly design.
Continued acceptance and future growth of the MiniMed 640G system with SmartGuard predictive low-glucose management, which has launched in Europe, Australia, and select countries in Latin America and Asia, and the MiniMed 620G system, the first integrated system customized for the Japanese market.