November 2, 2009 — Ascent Healthcare Solutions said last week it received the industry’s first and only 510(k) clearance from the U.S. Food and Drug Administration 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 percent 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 a value-add environmental benefit by recycling those devices that cannot be reprocessed.
The SoundStar 3D Ultrasound Catheter is a 90 cm 10 Fr. 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.
For more information: www.ascenths.com