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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 of aspirin and an anti-clotting medication following

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More from Policy & Regulation

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
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The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.