Medtronic Launches Arc Support Catheter Series In U.S. For Treatment Of Acute Ischemic Stroke

The Arc Support Catheter is the Most Navigable 6F Tapered Support Catheter Available, Providing Enhanced Delivery of the Solitaire( Stent Retriever

Medtronic plc recently announced the U.S. launch of the Arc support catheter, the most navigable, 6F tapered support catheter available. Developed to improve delivery of Medtronic's Solitaire(TM) stent retriever, the Arc support catheter provides the fastest route to restoration of blood flow in patients with complex anatomy suffering acute ischemic stroke.^1,2,3 The Arc catheter series received U.S. Food and Drug Administration 510(K) clearance in July 2015.

"The Arc support catheter establishes a new level of navigation performance for our most challenging patients," said Satoshi Tateshima, Professor of Neuro-Interventional Radiology at the University of California, Los Angeles (UCLA). "When combined with Medtronic's Solitaire stent retriever, this new system allows physicians to treat more challenging acute ischemic stroke patients and helps broaden our ability to service a larger segment of the population who suffer from this disease."

Recently, the American Heart Association/American Stroke Association (AHA/ASA) published new stroke treatment guidelinesthat recommend the use of stent retriever technology - such as Medtronic's Solitaire stent retriever device - in conjunction with the current standard of care, IV-tPA for eligible patients. The AHA/ASA guidelines are based on a panel of experts' analysis of the results from five global clinical trials published in The New England Journal of Medicine (NEJM) that found the addition of stent retriever technology, a surgical procedure that manually removes blood clots from the brain, to current medical therapy such as IV-tPA, has a therapeutic benefit over medical therapy alone.

The primary stent retriever studied in the five global trials was the Solitaire device. Three of the five trials - SOLITAIRE FR With the Intention For Thrombectomy as PRIMary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME),Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours (REVASCAT) and EXtending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial (EXTEND-IA) - studied the Solitaire stent retriever exclusively. The Solitaire device was the only stent retriever that was used in every one of the five NEJM-published randomized trials.

"The Arc support catheter will complement our Solitaire stent retriever and demonstrates our organization's focus on the treatment of stroke." said Brett Wall, president of the Neurovascular business, which is part of the Restorative Therapies Group at Medtronic. "The device also represents our organization's ability to continue to deliver innovative technology."

The Arc support catheter includes a patent-pending manufacturing technology called a "progressive coil design" which gives the device its unique performance features.

Of the 695,000 acute ischemic stroke victims in the U.S., about 240,000 are eligible for treatment with a stent retriever, like the Solitaire device. However, while these devices are available at more than 500 hospitals in the U.S., only about 13,000 procedures are performed annually.

About Medtronic
Medtronic plc , headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies technology - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 85,000 people worldwide, serving physicians, hospitals and patients in more than 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. For more information, visit www.medtronic.com.

¹ Arc Catheter Series Competitive Testing Report - TR- NV12169 (N = 10)
* Per TR- NV12169 navigability is defined by minimum average track force, aspiration is defined by overall size of inner lumen and kink resistance is defined by catheter's resistance to kinking under different diameters.

² Solitaire 2 IFU, Trevo Device IFU. Pai S.B, et al. Microsurgical Anatomy of the Middle Cerebral Artery, Neurology India. June 2005 Vol 53 . Issue 2.

³ Solitaire 2 IFU, Trevo Device IFU. Bench test study evaluating flow restoration performance of Solitaire 4x20 vs. Solitaire 4x40 Device. N=58. TR-NV11575A. Data on File.