SEC Filings

10-Q
MEDTRONIC PLC filed this Form 10-Q on 12/04/2017
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LINQ insertable cardiac monitor. The strong net sales growth in Heart Failure for the three and six months ended October 27, 2017 was also driven by strong demand for the CRT-P quadripolar pacing system, which launched in the U.S. in the first quarter of fiscal year 2018, as well as growth in Mechanical Circulatory Support during the three months ended October 27, 2017 due to the acquisition of of HeartWare, which was acquired in late August of fiscal year 2017.
Coronary & Structural Heart net sales for the three and six months ended October 27, 2017 were $854 million and $1.7 billion, respectively, an increase of 13 percent and 10 percent, respectively, as compared to the corresponding periods in the prior fiscal year. Coronary & Structural Heart net sales growth for the three and six months ended October 27, 2017 was largely driven by the continued strong customer adoption of the Evolut PRO Transcatheter Aortic Valve system (Evolut PRO) and the Evolut R 34mm transcatheter aortic heart valve, as well as continued penetration into intermediate risk in the U.S., which received approval late in the first quarter of fiscal year 2018. Net sales growth for the three months ended October 27, 2017 was also driven by the continued launch of the Resolute Onyx drug-eluting stent in the U.S. and Japan in the first quarter of fiscal year 2018.
Aortic & Peripheral Vascular net sales for the three and six months ended October 27, 2017 were $452 million and $891 million, respectively, an increase of 5 percent and 4 percent, respectively, as compared to the corresponding periods in the prior fiscal year. Aortic & Peripheral Vascular net sales growth for the three and six months ended October 27, 2017 was driven by strong performance in drug-coated balloons and success of the Endurant IIs aortic stent graft, as well as success of the Heli-FX EndoAnchor System. For the three months ended October 27, 2017, net sales growth was also driven by Percutaneous Transluminal Angioplasty (PTA) balloons and the recent launch of Concento 3D detachable coil system, as well as the Valiant Captiva thorasic stent graft systems. Continued strong adoption of the HawkOne 6 French directional atherectomy system also contributed to net sales growth for the three and six months ended October 27, 2017.
Looking ahead, we expect our Cardiac and Vascular Group could be affected by the following:
Changes in procedural volumes, competitive product launches and pricing pressure, geographic macro-economic risks, reimbursement challenges, impacts from changes in the mix of our product offerings, the timing of product registration approvals, replacement cycle challenges, and fluctuations in currency exchange rates.

Acceptance and future growth of the CRT-P quadripolar pacing system, which received CE Mark approval in February 2017 and launched in Europe during the fourth quarter of fiscal year 2017. In the U.S., we received Food and Drug Administration (FDA) approval in May 2017, and launched in the first quarter of fiscal year 2018.

Acceptance and future growth of the Claria MRI CRT-D system with EffectivCRT Diagnostic and Effective CRT during AF algorithm, which launched in the U.S. late in the third quarter of fiscal year 2017 and is expected to launch in Japan in fiscal year 2018.

Continued future growth from the Reveal LINQ insertable cardiac monitor, which launched in Japan in the second quarter of fiscal year 2017.

Continued future growth of our Micra transcatheter pacing system. Micra is a miniaturized single chamber pacemaker system that is delivered through the femoral vein and is implanted in the right ventricle of the heart. The system does not use a lead and does not have a subcutaneous device pocket underneath the skin as with conventional pacemaker systems. We received final approval for reimbursement in the U.S. from the Centers for Medicare & Medicaid Services and in Japan from the Ministry of Health, Labour, and Welfare during the fourth quarter of fiscal year 2017 and during the second quarter of fiscal year 2018, respectively, for this transformative therapy, which we expect will continue to accelerate sales in the U.S. and in Japan.

Acceptance and future growth of the HeartWare HVAD System as a Destination Therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, helps the heart pump and increases the amount of blood that flows through the body. In the U.S., we received FDA approval in September 2017 for this Destination Therapy indication.

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.


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