Ascent Gets 510(k) Clearances to Reprocess Coronary Bypass Devices
October 9, 2007 - Ascent Healthcare Solutions announced that the FDA has cleared two Ascent 510(k) submissions to reprocess specific Medtronic and Guidant cardiac stabilization and positioner devices, for use in in Off-Pump Coronary Artery Bypass (OPCAB) procedures.
The Medtronic models include the Octopus Evolution Tissue Stabilizer (as well as the other predecessor Octopus models), Starfish and Urchin Heart Positioners. Guidant models covered under this clearance include the complete line of vacuum and mechanical systems: Xpose, Ultima and Acrobat systems.
“Using a reprocessed device can reduce OPCAB procedure costs by $1,200 while maintaining the superior performance of the device. That not only helps keep healthcare costs lower, but also diverts waste from our overtaxed landfills," indicated According to Rick Ferreira, chief operating officer of Ascent. He added that a typical 250-bed hospital performing 100 procedures with OPCAB devices could save an average of $60,000 to $100,000 a year and redirect approximately 65 pounds of equipment away from disposal sites.
For more information: www.ascenths.com
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