Intravascular Catheters

Innovative Health received clearance from FDA to reprocess and market the ClosureFast™ varicose vein catheter. In collaboration with Northeast Scientific, Innovative Health is offering the reprocessed ClosureFast™ varicose vein catheter.

The ClosureFast™ catheter was designed to treat (ablation) varicose veins efficiently and effectively. The polymer outer sheath is strong and flexible. The device delivers RF energy directly to the diseased veins in the legs and requires little training.

The reprocessed ClosureFast™ catheter was cleared nearly 7 years ago and has been available in office based labs since then.

  • Innovative Health, in conjunction with NES, is the only reprocessor that can offer the ClosureFast™ catheter
  • Clearance for this catheter represents a milestone in reprocessing technology, since reprocessing the device involves novel methodologies not previously associated with reprocessing
  • Custom cleaning process and validation process
  • Over 300,000 catheters have been reprocessed and used clinically
  • Competing methods are laser, venaseal, vein stripping, clarivein

Safety

Intravascular catheters are reprocessed in a Class 10,000 clean room and utilize a high capacity RO/DI water system and only environmentally safe detergents.

Each ClosureFast catheter sent for reprocessing is subjected to four separate inspections during the reprocessing process before packaging and sterilization.

Sterilization is performed at the reprocessing facility using single-purpose ETO systems that limit waste and ensure sterility.

Our reprocessing services for ClosureFast catheters have been validated to meet all relevant performance and safety standards, including the applicable parts of the following industry standards:

ANSI/AAMI ST 35: Safe handling and biological decontamination of medical devices in health care facilities and in nonclinical settings

AAMI TIR 30: Cleaning validation for reprocessing of single use devices

ISO 10555:  Sterile, single-use intravascular catheters

ISO 11135: Sterilization of health care products – Ethylene Oxide

ISO 10993: Biological evaluation of medical devices

IEC 60601: Medical equipment/medical electrical equipment

AAMI 2-2 HF18: Medical electrical equipment – Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

ASTM F-1140: Internal pressurization failure resistance of unrestrained packages

ASTM D-3078: Determination of leaks in flexible packaging by bubble emission

Validated Reprocessing Process

Reprocessing Intravascular Catheters involves the following steps*:

*Some tests are performed during validation activities only.

Select a brochure below and click to download!

Reprocessed ClosureFast™ brochure coming soon.


IFUs