Ascent Receives 510(k) Clearance for Reprocessed Biosense Webster LASSO Circular Mapping Catheters


November 18, 2008

November 18, 2008 - Ascent Healthcare Solutions, said yesterday it received the industry's first 510(k) clearance from the FDA to reprocess the LASSO 2515 Variable Circular Mapping Catheter manufactured by Biosense Webster.

With this new clearance, Ascent continues to increase its portfolio of EP catheters to offer EP cath labs the ability to most effectively manage their resources while ensuring that clinicians have access to their preferred device to most effectively diagnose arrhythmias, the company said.

The average price for these reprocessed circular mapping catheters is $700; a savings of 53-58 percent, compared with the national average cost of $1,500-$1,650 when these devices are purchased directly from the original manufacturer. Ascent's focus on providing reprocessing and remanufacturing services for a wide range of high-cost, high-volume devices enables its hospital partners to reallocate its savings to staffing, services and technology that improve patient care. Hospitals using Ascent's services also help protect the environment through reprocessing, recycling and material reclamation, the company said.

The Biosense Webster LASSO 2515 Variable Circular Mapping Catheter has been designed to facilitate electrophysiological mapping of the atria of the heart and is deployed in the right or left atrium. The catheter features a variable loop that easily adjusts to any vein sized between 25 and 15 mm. Its adjustable tip provides efficient mapping and is also deflectable for maximum movement. It is available in 10 and 20-electrode configurations. These devices will be the first line of reprocessed diagnostic EP catheters to be packaged in Ascent's thermoformed tray.

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