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Insider analysis: Newly FDA-approved stroke drug may simplify in-hospital care

What will TNKase’s 5-second IV bolus mean for EMS stroke care?

What happened: A new stroke thrombolytic — tenecteplase — marketed as TNKase — has received FDA approval, marking the first such advancement in nearly 30 years. Unlike alteplase (tPA), which requires a lengthy infusion, TNKase can be administered as a 5-second IV bolus. Genentech will launch the drug in 25 mg vials, aimed at streamlining in-hospital acute stroke care.

MORE | FDA approves clot-dissolving agent for treatment of acute ischemic stroke

Highlights: Watch as Ed Bauter, MBA, MHL, NRP, FP-C, CCP-C; and Daniel Schwester, MICP, highlight the significance of this development, including:

  • New formulation offers simpler administration. Unlike the traditional 60-minute infusion required for tPA, TNKase is given via a quick 5-second IV push, which could significantly reduce treatment delays in hospital settings.
  • Limited impact for EMS in the near term. Although the administration method seems ideal for prehospital use, the complexities of stroke assessment — including CT imaging and neurologist evaluation — still limit EMS adoption.
  • Mechanical thrombectomy remains the gold standard. With thrombectomy becoming more prevalent and effective, thrombolytics like TNKase are increasingly seen as transitional therapies, especially in urban areas with comprehensive stroke centers.

MORE | On-demand webinar — Time is brain: Stroke assessment and treatment guidelines

The path forward: While TNKase represents a pharmacological leap for in-hospital stroke treatment, EMS providers are unlikely to see its use in the field anytime soon. The need for advanced diagnostics and physician oversight means EMS teams will continue focusing on rapid stroke identification and transport. However, mobile stroke units and rural settings may provide early glimpses of future prehospital applications.

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Ed Bauter, MBA, MHL, NRP, FP-C, CCP-C

Ed is a managing partner and chief executive officer of Overrun Productions, LLC; and co-host of The Overrun Podcast. Ed is a recovering medical student and paramedic.

His academic interests are in healthcare policy, team leadership and development, resuscitation and EMS medicine. Before attending medical school, he was a field preceptor and EMS educator for 10 years.

A second-generation paramedic, Ed works to inform the public about the importance of EMS and strives to encourage other EMS providers to move the profession forward using the most up-to-date data and technology.

He is a fan of old movies, the New Jersey Devils and the Philadelphia Eagles.

Daniel Schwester, MICP

Daniel Schwester has been a paramedic since 2000. He has served in a variety of roles including education, field training, clinical supervision and active practice as a paramedic.

He is the managing partner of Overrun Productions, LLC; and a co-host of The Overrun Podcast.

He is married to Jennifer, and is father to Caroline and William. He resides in Toms River, New Jersey.