Vascular Solutions Launches Reprocessing Service For ClosureFAST® Vein Catheters
Collaboration With Northeast Scientific Designed to Reduce Medical Waste and Lower Customer Costs
Minneapolis, MN (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today 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, Inc. division of Covidien, 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, Inc. (NES), an established third-party reprocessor of medical devices. NES received 510(k) clearance from the U.S. Food and Drug Administration on November 30, 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 U.S. hospitals are now contracting with third-party reprocessors for a wide variety of medical devices," said Howard Root, Chief Executive Officer of 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 $70 million in annual sales in the U.S."
NES has granted Vascular Solutions the exclusive right through December 31, 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, sterilization, 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, Chief Executive Officer of NES. "We know that Vascular Solutions shares our commitment to patient safety and product performance, and we are happy to be working with a company with a nationwide direct sales force that is already experienced with the needs of the vein therapy clinical community."
About Vascular Solutions
Vascular Solutions, Inc. (Nasdaq:VASC), headquartered in Minneapolis, Minnesota, is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. Founded in 1997, the company's product line consists of more than 50 devices in three categories: catheter products, hemostat products, and vein products. The company's vein products include the Vari-Lase® line of laser consoles and procedure kits for the endovenous treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein. Vascular Solutions delivers its products to interventional cardiologists, interventional radiologists, electrophysiologists, and vascular surgeons through its direct U.S. sales force and international independent distributor network.
For further information about the company, connect to www.vasc.com.
About Northeast Scientific
Northeast Scientific, Inc. (NES), a privately-held company headquartered in Waterbury, Connecticut, is registered with the U.S. Food and Drug Administration as a reprocessor of single-use medical devices. Founded in 2005, NES received its first 510(k) clearance in September 2007. NES's facility was designed specifically to reprocess single-use devices. The process employs a high capacity reverse osmosis (RO) deionized (DI) water system for cleaning, and the company uses only environmentally safe detergents. NES uses a high-end vacuum drying system to ensure dry product and the absence of residues. Each ClosureFAST catheter sent to NES for reprocessing is subjected to four separate inspections during the reprocessing cycle before packaging and sterilization. NES uses only heat-seal tyvek/poly pouches to guarantee packaging integrity, and it performs all sterilization in-house with 3M 100% ethylene oxide (EtO) systems that limit waste and ensure sterility. Functional testing of each reprocessed device and heat-seal packaging is carried out in NES's Class 10,000 clean room.
NES's reprocessing of ClosureFAST catheters has 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), AMI 2-2 HF 18 (Medical electrical equipment – Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical accessories), ASTM F-1140 (internal pressurization failure resistance of unrestrained packages), and ASTM D-3078 (determination of leaks in flexible packaging by bubble emission).
For more information about NES, connect to www.mdreprocess.com.
About ReprocessingAccording to the Association of Medical Device Reprocessors (AMDR), between 1997-2007 the reprocessing industry safely handled more than 50 million devices and prevented more than 10,000 tons of medical waste from entering landfills.
AMDR describes reprocessing as follows: "Third-party reprocessors inspect, functionally test, clean, package, and sterilize medical devices labeled for single-use in such a manner that the quality, physical characteristics, and performance functions of the device are not significantly affected and that the device remains safe and effective for its appropriate use."
Some of the medical devices most commonly reprocessed by third-party reprocessors include EP catheters, orthopedic surgical blades, deep vein thrombosis compression sleeves, laparoscopic instruments, tourniquet cuffs, saw blades, cardiac stabilizers, and pulse oximetry sensors.
ClosureFAST is a registered trademark of Tyco Healthcare Group, LP. Vascular Solutions' reprocessing service for the ClosureFAST catheter is not licensed by or associated with VNUS Medical Technologies, Inc.
The information in this press release contains forward-looking statements that involve risks and uncertainties. Vascular Solutions' results could differ materially from those anticipated in these forward-looking statements. Important factors that may cause such differences include those discussed in our Annual Report on Form 10-K for the year ended December 31, 2011 and other recent filings with the Securities and Exchange Commission. The risks and uncertainties include, without limitation, risks associated with the need for adoption of our new products or services, lack of sustained profitability, exposure to intellectual property claims, significant variability in quarterly results, exposure to possible product liability claims, the development of new products by others, doing business in international markets, the availability of third party reimbursement, and actions by the FDA.
SOURCE: Vascular Solutions, Inc.
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