Angiodynamics Initiates Thrombectomy Trial In Europe After Showing Positive Trial Results in US

According to Zacks Equity Research, the new trial seeks to support AlphaVac’s adoption in the European market, where pulmonary embolism prevalence and severity is an estimated 435,000 events annually.

Pulmonary Embolism
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AngioDynamics, Inc. has initiated the RECOVER-AV clinical trial of its AlphaVac Multipurpose Mechanical Aspiration F1885 system for treating intermediate-risk pulmonary embolism in Europe, following the success of the US-based APEX-AV trial.

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Pushing On An Open EU Door? Time For MHRA To Get Practical About UK’s Regulatory Ambition

 
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The UK’s “New Approach” to regulation has created a lot of noise, but what’s the end product? asks Taylor Wessing partner Alison Dennis, who says the UK medtech regulator should look afresh at the EU’s ready-made solution.

US Medtech Tariffs: How Will EU Navigate Unchartered Territory?

 

US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.

UK Treading A Tightrope On Trump’s Tariffs

 
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Medtech has not yet been spared from the Trump administration’s trade tariffs, which, for UK exporters will be 10% – half the rate applied to EU27 exporters.

Swiss Blast US Import Tariffs As Medtechs Look For Dialog To Forestall Damage To Industry

 
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Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.

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FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.

HHS Has ‘Utterly Failed,’ Kennedy Advisor Argues

 
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Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

Some Staff Say Makary’s First Speech To FDA Off-Target Despite Science Focus

 

Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.