SEC Filings

10-Q
MEDTRONIC PLC filed this Form 10-Q on 09/01/2017
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pacemaker systems. During the fourth quarter of fiscal year 2017, we received final approval for reimbursement in the U.S. from the Centers for Medicare & Medicaid Services for this transformative therapy, which we expect will accelerate sales in the U.S.

Continued acceptance and future growth from Care Management Services as post-acute care services become even more critical in bundled payment models for different interventions or therapies.

Continued acceptance and future growth from Evolut R 34mm transcatheter aortic heart valve, our next-generation recapturable system with differentiated 16 French equivalent delivery system, which was launched in the U.S. in the third quarter of fiscal year 2017.

Acceptance and future growth from Evolut PRO, which provides control during deployment to assist with accurate positioning with the ability to recapture and reposition the valve. Evolut PRO received U.S. FDA approval and launched in the fourth quarter of fiscal year 2017. Evolut PRO also received CE Mark approval at the end of the first quarter of fiscal year 2018 and will launch in Europe during the second quarter of fiscal year 2018.

Acceptance and future growth from the market release of Resolute Onyx, which launched in the first quarter of fiscal year 2018 in the U.S. and in Japan. 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 procedures.

Continued acceptance and future growth of the IN.PACT Admiral drug-coated balloon, including the longer length 150mm sizes, for the treatment of peripheral artery disease in the upper leg.

Continued acceptance and future growth from the HawkOne 6 French (6F) for treating patients with peripheral artery disease (PAD), which launched in the U.S. in the third quarter of fiscal year 2017. The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow. The new HawkOne 6F provides an effective and easy-to-use treatment option for patients with PAD both above and below the knee with a single device at a lower profile.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group’s products span the entire continuum of care with a focus on diseases of the gastrointestinal tract, lungs, pelvic region, kidneys, obesity, and preventable complications. The products include those for advanced and general surgical care, wound closure, electrosurgery products, hernia mechanical devices, mesh implants, advanced ablation, interventional lung, ventilators, capnography, airway products, sensors, dialysis, and monitors. Net sales results for the three months ended July 28, 2017 and July 29, 2016 also include sales of compression, enteral feeding, wound care, and medical surgical product lines which were divested to Cardinal Health on July 29, 2017. The Minimally Invasive Therapies Group’s net sales for the three months ended July 28, 2017 were $2.5 billion, an increase of 3 percent as compared to the first quarter in the prior fiscal year. Currency had an unfavorable impact on net sales for the three months ended July 28, 2017 of $14 million as a result of the change in exchange rates from the three months ended July 29, 2016. The Minimally Invasive Therapies Group's net sales for the three months ended July 28, 2017 benefited from the acquisition of Smith & Nephew's gynecology business in the second quarter of fiscal year 2017. See the more detailed discussion of each division's performance below.
Surgical Solutions net sales for the three months ended July 28, 2017 were $1.4 billion, an increase of 4 percent as compared to the corresponding period in the prior fiscal year. Surgical Solutions net sales growth was driven by ongoing new product launches in Advanced Stapling and Advanced Energy. In Advanced Stapling, endo stapling specialty reloads with Tri-Staple technology are driving growth, as well as the continued adoption of the Signia powered stapler, which contributed growth across the regions in which it has been launched. Advanced Energy benefited from the launch of new LigaSure vessel sealing instruments, the Valleylab F10 energy platform, and growth in emerging markets. Surgical Solutions also benefited from the acquisition of Smith & Nephew's gynecology business, which was acquired during the second quarter of fiscal year 2017.

Patient Monitoring & Recovery net sales for the three months ended July 28, 2017 were $1.1 billion, an increase of 1 percent as compared to the three months ended July 29, 2016. Patient Monitoring & Recovery net sales growth was driven by sales of Nellcor pulse oximetry products, Capnostream capnography monitors, capnography disposables, and growth in emerging markets.


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