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Impulse Dynamics NV

www.impulse-dynamics.com

Latest From Impulse Dynamics NV

FDA Approves Impulse Dynamics’ Optimizer Smart For Heart Failure As Breakthrough Device

The Optimizer Smart implantable pulse generator delivers Cardiac Contractility Modulation therapy to improve the quality of life and functional status of patients with advanced heart failure who are not indicated for cardiac resynchronization therapy. The agency granted Optimizer Smart as a Breakthrough Device because of its potential to improve outcomes for heart failure patients without other options.

Approvals Commercial

Global Device Approvals Snapshot For March 18 - March 25, 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week FDA approved Impulse Dynamics’ Optimizer Smart impulse generator for cardiac contractility modulation therapy, CardioFocus’ HeartLight Endoscopic Ablation system earned a CE Mark, and Health Canada approved a new version of DarioHealth’s smart-phone compatible continuous glucose monitor.

Approvals Research & Development

FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device

A US FDA panel overwhelmingly supported a heart-failure device designed to use cardiac contractility modulation to improve heart function. The Optimizer Smart system from Impulse Dynamics is apparently the first in FDA’s Breakthrough Devices program to go before an advisory panel.

Advisory Committees FDA

Hypertension Devices Will Get US FDA Panel Focus

FDA has set a panel meeting date in December that will include discussion of trial designs and potential indications for devices being developed to treat hypertension. Also, the advisory panel will look at an implantable device seeking approval for use in heart-failure patients.

Advisory Committees Innovation
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Company Information

  • Industry
  • Medical Devices
    • Implantable Devices
  • Therapeutic Areas
  • Cardiovascular
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • Europe
      • Western Europe
        • Germany
  • Parent & Subsidiaries
  • Impulse Dynamics NV
  • Senior Management
  • Simos Kedikoglou, MD, CEO
    Andrew Coll, CFO
    Daniel Burkhoff, MD, PhD, CMO
    Mateusz Zelewski, MD, PhD, VP, Intl. Sales
  • Contact Info
  • Impulse Dynamics NV
    Phone: (599) 711 220456-0
    Breitwiesenstraße 19
    Stuttgart, 70565
    Germany
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