‘Alarming’ Paclitaxel-Coated Device Findings Trigger UK Safety Probe

An expert advisory group set up by UK regulators has been given a few months to review the safety of paclitaxel-eluting balloons and stents in the treatment of patients with peripheral arterial disease, following a recent study that produced worrying results.

Stent
There are concerns over the safety of paclitaxel-coated balloons and stents • Source: Shutterstock

UK regulators have set up an independent expert advisory group (EAG) to review the safety of paclitaxel-coated balloons and stents, after recent research raised concerns over an increased risk of death when these devices are used to treat patients with peripheral arterial disease, particularly when implanted in the femoropopliteal artery.

The EAG has begun the process of reviewing the available but highly complex information on these medical devices, the Medicines...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United Kingdom

Fallouh Healthcare Receives Grant Funding From Innovate UK

 

Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

UK Trails NHS 10-Year Plan With Launch Imminent

 
• By 

Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

£2Bn Industrial Strategy Boost For UK Life Sciences Growth Sector

 
• By 

The Modern Industrial Strategy is the first of this summer’s UK blueprints for supporting life sciences industrial activity and transforming NHS healthcare delivery. The UK market must also benefit from its own innovation activity, says industry.

More from Europe

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

£2Bn Industrial Strategy Boost For UK Life Sciences Growth Sector

 
• By 

The Modern Industrial Strategy is the first of this summer’s UK blueprints for supporting life sciences industrial activity and transforming NHS healthcare delivery. The UK market must also benefit from its own innovation activity, says industry.