Innovative Health Receives FDA Clearance to Reprocess the Webster Duo-Decapolar EP Catheter

Innovative Health, a single-use cardiology medical device reprocessing company, has received U.S. Food and Drug Administration (FDA) clearance for reprocessing the Webster Duo-Decapolar Diagnostic EP Catheter. The 20-electrode EP catheter is used in electrophysiological mapping of cardiac structures, such as in Atrial Fibrillation procedures.
 
Innovative Health already has clearance to reprocess a large portfolio of Biosense Webster’s diagnostic, ultrasound, and mapping catheters, and the addition of the Webster Duo-Decapolar Diagnostic EP catheter, which has a $1,000 price tag new, represents another important means for EP labs to significantly reduce procedure costs.
  
“As the nation’s EP reprocessor with the fastest growing FDA clearance portfolio, we continue to invest in hospitals’ ability to drive down device costs. Many EP labs across the country rely on us to reduce procedure costs”, said Innovative Health CEO Rick Ferreira. “As a specialty reprocessor, Innovative Health is able to focus on a specific clinical area, develop deep clinical and scientific competencies, and work with FDA on our submissions to achieve clearance and make higher savings available.”
 
With this FDA clearance coming after clearance to reprocess PENTARAY, Innovative Health cements its leadership in cardiac device reprocessing, gaining more recent FDA clearances in this area than any other reprocessor.
 
* The Webster Duo-Decapolar Diagnostic EP Catheter and PENTARAY are trademarks of or licensed to Biosense Webster Inc. or one of its subsidiaries.
 
The single-use device reprocessing industry has emerged a vital link in the medical device industry’s supply chain by focusing on making these “single-use” devices available for another use. Unlike reprocessors of reusable devices, reprocessors of single-use medical devices must achieve FDA clearance to market medical devices and are under strict regulatory oversight. Single-use device reprocessing is used by 19 of the top 20 U.S. News & World Report hospitals and is widely celebrated as a key supply chain strategy in hospitals.
 
Innovative Health is a medical device reprocessing company that offers smarter utilization of medical devices in hospitals’ cardiology and electrophysiology programs.