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FDA Approves Medtronic’s Resolute Onyx DES With Short-Term Dual-Antiplatelet Therapy

 
• By Reed Miller

The agency approved Medtronic's zotarolimus-eluting coronary stent for patients with a high bleeding risk who are treated with one month of dual-antiplatelet therapy.

MDT Onyx Clear
Medtronic's Resolute Onyx zotarolimus-eluting coronary stent • Source: Medtronic PLC

The US Food and Drug Administration expanded the approved indication for Medtronic plc’s Resolute Onyx zotarolimus-eluting coronary stent to include patients at high risk for bleeding who will be on dual-antiplatelet therapy for just one month following the intervention.

Resolute Onyx is the only drug-eluting stent approved by the FDA for patients who can only tolerate a one-month regimen...

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• By Elizabeth Orr

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FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
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More from Policy & Regulation

FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
• By Amanda Maxwell

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

Cardiology And PTA Procedures In Germany’s Expanded Hybrid DRGs List 2026

 
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Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By Elizabeth Orr

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.