April 24, 2007 — Ascent Healthcare Solutions announced today that the FDA has increased the number of times that Ascent can reprocess the Siemens AcuNav Ultrasound Catheter from two to up to four times. Validation data submitted to the FDA covered all available models.
The catheters provide electrophysiologists and interventional cardiologists with high- quality images and blood flow information throughout the entire heart for the diagnosis of certain cardiac arrhythmias.
Ascent originally received clearance to reprocess the catheters in March 2005. As a part of Ascent's validation procedures required for FDA 510(k) clearance, numerous, repeatable mechanical and electrical tests are performed.
Ascent's reprocessed AcuNav Ultrasound diagnostic catheter testing roadmap guarantees 100 percent electrical transducer functionality for all reprocessed devices through four reprocessing cycles. Ascent technicians and quality control inspectors examine and test every device at multiple points during reprocessing to ensure that each will perform as intended. They reject any device that does not pass every inspection and test.
In addition to testing for functionality, Ascent engineers and independent national laboratories performed extensive testing to validate that these reprocessed catheters will be clean, sterile and pyrogen free when they are returned to hospitals.
For more information visit www.ascenths.com.