Ascent Healthcare Solutions Receives 510(K) Clearance To Reprocess Biosense Webster SoundStar™ 3D Diagnostic Ultrasound Catheter

Main Category: MRI / PET / Ultrasound
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 29 Oct 2009 - 16:00 PDT

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Ascent Healthcare Solutions, a leader in delivering healthcare resource sustainability, announced that it has received the industry's first and only 510(k) clearance from the U.S. Food and Drug Administration (FDA) to reprocess the Biosense Webster SoundStar™ 3D Diagnostic Ultrasound Catheter. With this new clearance, Ascent continues to lead the charge in bringing sustainability to healthcare. Ascent's clearance represents an immediate savings opportunity of up to 51% of the cost of the original device, providing hospitals with a solution for more effectively managing device costs associated with their technology investment. In reprocessing the SoundStar catheter, Ascent also brings its signature, value-add environmental benefit by recycling those devices that cannot be reprocessed.

The SoundStar 3D Ultrasound Catheter is a 90 cm 10F Intra Cardiac Echo (ICE) Catheter with an acoustic array. The catheter has a location sensor (providing location information to the CARTO® EP XP Navigation System) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip.

Rick Ferreira, Chief Operating Officer of Ascent Healthcare Solutions, stated, "The engineers and medical professionals in our research and development teams work diligently to identify those devices that can be safely reprocessed - and that can bring substantial savings to the hospital's bottom line using environmentally sound practices.

"Despite the recession, we found hospitals that prioritized investment in this new technology among their shrinking capital purchases. We knew that the ability to reprocess the device would be a valuable source of savings to help offset the cost of the investment and allow hospitals to continue to leverage these cutting-edge technologies to improve the healthcare experience."

Source
Ascent Healthcare Solutions