Landmark SPYRAL HTN-OFF MED Pivotal Trial Shows Superiority for Renal Denervation in Patients with High Blood Pressure Compared to Sham Procedure - Seite 2

Medtronic also recently received Breakthrough Device Designation by the FDA for the Symplicity Spyral renal denervation system. The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain technologies, such as renal denervation, that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. 

Hypertension is the single largest contributor to cardiovascular death; it dramatically increases risk of heart attack, stroke, heart failure, and kidney failure. The annual direct costs of hypertension are estimated at approximately $400 billion worldwide. It is estimated that almost 20% of patients with uncontrolled hypertension are completely non-adherent to oral medications, while nearly half are partially non-adherent, highlighting the need for alternative treatment options.

The SPYRAL HTN-OFF MED Pivotal Trial is part of the SPYRAL HTN Global Clinical Trial Program and accompanies the SPYRAL HTN-ON MED Trial and the SPYRAL DYSTAL Study. Along with the Global Symplicity Registry, conducted outside the United States, Medtronic’s renal denervation program includes more than 4,000 patients, studied in the presence and absence of medication, and in patients with high baseline cardiovascular risk. Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral system is limited to investigational use in the United States, Japan and Canada.

Analyst and Investor Briefing
Medtronic will host a webcast on Sunday, March 29, 2020, from 4:00 p.m. to 5:00 p.m. Central Daylight Time. The webcast will feature remarks on the company and recent clinical data announcements from the Medtronic Cardiac and Vascular Group management team. The live audio webcast can be accessed by clicking on the Investor Events link at http://investorrelations.medtronic.com on March 29. Within 24 hours of the webcast, a replay will be available on the same page. This event is not part of the official ACC.20/WCC program.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 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.

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Joey Lomicky
Public Relations
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Ryan Weispfenning
Investor Relations
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