EP MedSystems Receives Regulatory Approval for Integrated Electrophysiology System

Strategic Insights -

EP MedSystems, Inc. has obtained regulatory approval from the European Notified Body for its integrated electrophysiology system, which combines the company's EP-WorkMate workstation with Boston Scientific Corp.'s RPM technology. This approval allows the company to sell the product in the 15 countries of the European Community, marking a significant milestone in its growth strategy. The new system, the only one available on the market to integrate advanced recording and stimulation, anatomic modeling, advanced mapping, and 3-D navigation features, is expected to increase market opportunities and efficiency for physicians.

Key Takeaways:

  • EP MedSystems has received regulatory approval from the European Notified Body for its integrated electrophysiology system, marking a significant milestone in its growth strategy.
  • The system combines the company's EP-WorkMate workstation with Boston Scientific Corp.'s RPM technology and is currently the only EP recording system available on the market to integrate advanced features.
  • The approval allows the company to sell the product in the 15 countries of the European Community, expanding its market reach.
  • The system is expected to increase efficiency and user-friendliness for physicians performing electrophysiologic studies.
  • Reinhard Schmidt, EP MedSystems' president and CEO, comments on the approval as a significant step in the company's roll out of new products into the marketplace.
  • The RPM upgrade provides an easy and cost-effective way for EP MedSystems' installed base to participate in the market trend toward anatomical modeling, advanced mapping, and 3-D navigation for complex ablation procedures.
  • International expansion is a key driver of future growth for EP MedSystems, and this approval is a successful step in its growth strategy.

Statistics:

  • 15 countries in the European Community where the product will be sold
  • EP MedSystems has a strong response in the United States from the joint-development project with Boston Scientific Corp.
  • The number of complex ablation procedures expected to increase with the adoption of the new system
  • 100% of EP MedSystems' installed base can participate in the market trend with the RPM upgrade

Sources:

  • Health & Medicine Week editors, "EP MedSystems Earns Regulatory Approval for Integrated Electrophysiology System", August 23, 2004.
  • NewsRx.com & NewsRx.net, "EP MedSystems Receives Regulatory Approval for Integrated EP-WorkMate with RPM"