Vascular Solutions announced that it is marketing a reprocessing service for the ClosureFAST radiofrequency ablation catheter in the United States. The ClosureFAST catheter, which is manufactured and marketed by VNUS Medical Technologies, is widely used for performing endovenous therapy for the treatment of varicose veins. Vascular Solutions’ reprocessing service is designed to help physicians reduce medical waste and lower their costs.
Vascular Solutions is offering the reprocessing service under contract with Northeast Scientific (NES), an established third-party reprocessor of medical devices. NES received 510(k) clearance from the US Food and Drug Administration (FDA) on 30 November 2011 for reprocessing the ClosureFAST catheter.
“Reprocessing has proven to be a safe and effective way for hospitals and clinics to cut down on medical waste and reduce operating costs. As a result, the vast majority of US hospitals are now contracting with third-party reprocessors for a wide variety of medical devices,” said Howard Root, CEO, Vascular Solutions. “Reprocessing has become one of the fastest-growing segments of the medical device industry, and we are very pleased to be entering this market in collaboration with NES for the ClosureFAST catheter, which we estimate to be generating in excess of US$70 million in annual sales in the USA.”
NES has granted Vascular Solutions the exclusive right through 31 December 2016 to market the ClosureFAST reprocessing service to hospitals and clinics within the United States through Vascular Solutions’ direct sales force. Vascular Solutions has already begun to take orders for the ClosureFAST reprocessing service and NES has begun to receive used ClosureFAST catheters from several of these customers for reprocessing.
Hospitals and clinics that subscribe to the service send their used ClosureFAST catheters directly to NES for reprocessing. Upon completion of reprocessing, customers receive those same catheters back, ready for a second use. NES’s validated reprocessing system for the ClosureFAST catheters involves multiple stages, including decontamination, cleaning, drying, packaging, labeling, sterilisation, and biological quarantine testing. As part of the process, each catheter is subjected to function testing and undergoes multiple inspections to ensure that quality standards are met.
“Regulators hold third-party processors such as NES to extremely high standards for safety and effectiveness, and we are proud that we have successfully completed 46 different tests to document that our reprocessed vein ablation catheters meet the industry’s highest performance standards,” said Craig Allmendinger, CEO, NES.