Innovative Health said it has nabbed FDA clearances to reprocess diagnostic catheters made by St. Jude Medical, Medtronic and Biosense Webster.
The catheters include St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s Decanav. Innovative Health said it is the first in the industry to receive clearances to reprocess the Advisor and the Decanav, and the only reprocessor to offer services to cardiac mapping and diagnostic ultrasound catheters from all major electrophysiology device manufacturers.
Scottsdale, Ariz.-based Innovative has landed 23 FDA clearances for ultrasound catheter reprocessing in the past two years, including the ViewFlex Xtra by St. Jude and all models of the Biosense Webster’s Soundstar and Acunav.
By reprocessing these devices, hospitals can save hundreds of thousands of dollars, according to he company. Innovative Health partners with hospitals to collect these catheters, then applies a rigorous, proprietary process to clean, test and sterilize them for re-use. These processes face heavy scrutiny by the FDA, which must issue a clearance before any device can be reprocessed.
“Now that we’ve received the clearance to begin reprocessing Decanav, Advisor, Torqr and Marinr, Innovative Health is clearly poised to dominate the reprocessing industry across all types of catheters,” Innovative CEO Rick Ferreira said in a prepared statement. “Our focus on increasing savings for EP labs is working and has cemented our position as the leading innovator in the reprocessing industry.”