1. Medtech Insight
  2. >>Business
  3. >>R&D
  4. >>Clinical Trials

Cardiovascular Devices For Hypertension: FDA Outlines Clinical Trial Tips

FDA offers advice for designing clinical trials of cardiovascular devices to treat drug-resistant hypertension, as several major players look to stake a claim in the space.

Clinical trials of cardiovascular devices to treat drug-resistant hypertension should show a clinically significant decrease in blood pressure at six months, as well as a solid safety profile out to five years, according to FDA.

The tips were among those outlined by agency staffers earlier this month, as several major players look to stake a...

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
Start Free Trial

Already a subscriber?

More from Clinical Trials

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By Marion Webb

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

No Strings Attached: Big Players Chase Insulet In Fast-Growing Tubeless Insulin Pump Market

 
• By Marion Webb

Medtronic, Tandem and Beta Bionics are gearing up to bring tubeless patch pumps to market, chasing Insulet’s Omnipod 5, the only FDA-cleared patch pump for type 1 and type 2 diabetes. Analysts expect tubeless models to eventually displace durable pumps.

More from R&D