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

HRS 2018: Optimizer Cardiac Contractility Device Helps Subset Of Heart-Failure Patients

 
• By Reed Miller

The FIX-HF-5C trial, a subgroup study derived from the FIX-HF-5 pivotal trial, shows that the Impulse Dynamics Optimizer cardiac contractility modulation device significantly improved exercise tolerance and quality of life in certain heart-failure patients. Results of the trial were presented at the Heart Rhythm Society conference in Boston. Impulse Dynamics expects to file the final PMA module for US FDA for Optimizer in June.

View of the Boston Harbor in Boston, Massachusetts, USA with its mix of modern and historic architecture in a cross processed image.

Results of the FIX-HF-5C study confirming the benefits of Impulse Dynamics NV's Optimizer cardiac contractility modulation (CCM) device on endpoints that are important to heart-failure patients, including exercise capacity and quality of life, while also demonstrating the system's potential to reduce heart-failure morbidity and mortality, according to principal investigator William Abraham of Ohio State University in Columbus, Ohio (US).

Specifically, 12- and 24-week follow-up data from FIX-HF-5C showed that Optimizer significantly improved exercise tolerance and quality of life in...

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

Roche Eyes 2026 FDA Nod After CE Mark For pTau181 Test To Boost Global Alzheimer’s Diagnosis

 
• By Shubham Singh

The Elecsys pTau181 test, which requires only a blood sample, provides a less invasive alternative to cerebral spinal fluid procedures. A negative result could rule out Alzheimer’s and help patients avoid further testing with CSF or PET scans.

HistoSonics Sells Majority Stake To Investor Syndicate In Deal Valued At $2.25Bn

 
• By Marion Webb

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

CorTec Begins First Human Trial Of Wireless Brain Implant For Stroke Rehab

 
• By Marion Webb

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

More from R&D

CorTec Begins First Human Trial Of Wireless Brain Implant For Stroke Rehab

 
• By Marion Webb

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

NIH-Backed Scanner Opens New Frontier For Understanding The Human Brain

 
• By Brian Bossetta

A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.