1. Medtech Insight
  2. >>Business
  4. >>Clinical Trials

Trial Results Fail To Support Mainstay Medical's Neuromodulation Device

 
• By Catherine Longworth

Mainstay Medical says it will move forward with a US PMA application for its ReActiv8 neuromodulation therapy for chronic back pain even though the ReActiv8 clinical trial failed to reach its primary endpoint.

ReActiv8
• Source: Mainstay Medical

Mainstay Medical International PLC believes it has enough data to move forward with a PMA application to US FDA for its ReActiv8 implantable spinal neuromodulator device to treat chronic back pain, even after its ReActiv8-B trial did not reach the primary endpoint in a key clinical trial.

In ReActiv8 B, a total of 204 patients were surgically implanted with the device at centers in the US, Europe,...

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

Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

With CMS Coverage Established, Medtronic Looks To Next Steps For Renal Denervation

 
• By Elizabeth Orr

US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the

PFA Market Surges As UK NICE Opens Doors And US FDA Approves Boston, J&J Incremental Innovations

 
• By Natasha Barrow

The pulsed-field ablation market is surging, with the UK NHS opening doors and FDA updates for major players. Medtech Insight spoke with Steven Mickelsen, founder of Farapulse (the first clinically approved PFA system), about the sector's growth and his new venture, Field Medical.

Medicare Tricuspid Regurgitation Coverage Decision Big Win For Abbott

 
• By Brian Bossetta

Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.

More from R&D