• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA panel votes in support of Impulse Dynamic’s cardiac contractility modulation pulse generator

FDA panel votes in support of Impulse Dynamic’s cardiac contractility modulation pulse generator

December 6, 2018 By Fink Densford

Impulse Dynamics

The FDA’s Circulatory Systems Device Panel this week voted in favor of Impulse Dynamics’s Optimizer Smart implantable pulse generator, supporting the company’s premarket approval application seeking clearance for use in patients suffering from heart failure, according to a Healio report.

The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency using what the company calls the cardiac contractility modulation – non-excitatory electrical pulses delivered to the heart muscle. The system has had CE Mark approval in the European Union for the device since 2002.

The FDA’s Circulatory Systems Device Panel voted 12 to 1 in favor of the device’s safety and 11 to 2 in favor of its efficacy, according to Healio. The panel also voted 12 to 0, with a single abstention, that benefits of the device outweighed the risks.

The device came supported by safety and efficacy evidence from the 418-patient FIX-HF-5 study of the device, which compared treatment with CCM to guideline-directed medical therapy for heart failure patients, according to the report.

The trial’s primary safety endpoint was defined as a composite event rate of all-cause hospitalizations and all-cause mortality through 50 weeks, which was reported at 4.9% in the CCM treatment arm and 3.3% in the control arm, according to Healio. No deaths were reported as caused by the implant procedure or the device, and rates of events that required invasive treatment or hospitalization were balanced between groups.

The primary effectiveness endpoint of the trial, defined as the difference in responder rates between the CCM and control groups, was reported at 5.9%, with a 17.6% rate in the CCM arm and 11.7% in the control group. The difference was not reported as being statistically significant.

The system was also supported by data from the 160-patient FIX-HF-5C study which had a similar patient population to the FIX-HF-5 study, according to Healio.

The primary safety endpoint in the second trial was defined as the percentage of CCM patients who experienced either device- or procedure-related complications through 24 weeks. Results indicated that 90% of CCM patients were free from complications at follow-up, according to the report.

The primary effectiveness endpoint in the trial was the mean difference in peak VO2 between the CCM and control arms at 24 weeks. Investigators included data from nearly 30% of patients from the FIX-HF-5C study for assessing the endpoint, Healio reports. With imputation of zeroes performed to account for six deaths, peak VO2 was 14.21 ml/kg/min for the control arm vs 15.04 ml/kg/min for the CCM arm, from baseline VO2 levels of 15.4 ml/kg/min.

A registry for a post-approval study was proposed that will seek to collect data from 300 patients for two years, with a similar format to left atrial appendage occlusion and transcatheter aortic valve replacement registries, according to the report. Investigators in the study plan to review all-cause mortality and 1- and 2-year mortality assessments as compared with the Seattle Heart Failure Model scoring system.

The company won a date with an FDA panel in October. Last May, Impulse Dynamics said that it closed a $45 million equity financing round to support its CCM tech.

Filed Under: Cardiac Implants, Cardiovascular, Food & Drug Administration (FDA), Regulatory/Compliance, Structural Heart Tagged With: Impulse Dynamics

More recent news

  • Aurora Spine begins first procedures with Aero lumbar fusion system
  • Caranx Medical surgical robot TaviPilot AI software wins FDA clearance
  • InspireMD launches carotid stent in U.S. after FDA approval
  • Neuros Medical raises $56M Series D to support nerve stim tech
  • CorWave reports first-in-human LVAD implant

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy