- Reprocessing of popular vein treatment catheter results in significant cost savings and reduced medical waste for U.S. vein clinics
- Excellent safety record established, with no serious adverse patient events reported since reprocessing began in January of 2012
- With recent launch of 0.025" guidewire, Vascular Solutions now offers a complete package of accessory products for RF vein ablation procedures
MINNEAPOLIS, Sept. 16, 2013 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq: VASC ) today announced that more than 30,000 ClosureFAST catheters have been successfully reprocessed by its partner, Northeast Scientific, Inc. (NES), since Vascular Solutions launched the reprocessing service for the popular vein ablation catheters on January 16, 2012.
Vascular Solutions today also announced the availability of its new VSI 0.025" Guidewire for use during ClosureFAST procedures. A 0.025" guidewire is commonly used during radiofrequency vein ablation procedures to facilitate placement of the ClosureFAST catheter into desired treatment locations.
"Our reprocessing service for the ClosureFAST catheter represents a beneficial opportunity for U.S. vein clinics to significantly reduce their costs and cut down on medical waste," said Howard Root, Chief Executive Officer of Vascular Solutions. "During the first 20 months that it has been available, our service has established an excellent safety record, with more than 30,000 catheters successfully reprocessed and no serious adverse patient events reported. Also, with the launch of our new 0.025" guidewire, Vascular Solutions now offers a full range of accessory products for RF vein ablation procedures."
Reprocessing of the ClosureFAST catheter is a service offered exclusively by Vascular Solutions in collaboration with NES. To date, over 460 U.S. vein practices have contracted with Vascular Solutions to have their ClosureFAST catheters reprocessed by NES. Approximately 65% of the customers for the reprocessing service have been entirely new accounts for Vascular Solutions.
"Our reprocessing partner, NES, has done a great job of meeting physicians' demands for a reliable source of reprocessed ClosureFAST catheters," Mr. Root said. "We are very pleased with the results of our ClosureFAST reprocessing program to date and we look forward to continued success with this service."
The ClosureFAST radiofrequency ablation catheter, which is manufactured and marketed by Covidien, is the most popular product used for performing endovenous therapy for the treatment of varicose veins in the U.S. Vascular Solutions is offering the reprocessing service under contract with 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.
Craig Allmendinger, Chief Executive Officer of NES, commented: "Reprocessing is one of the fastest-growing segments of the medical device industry, and the vast majority of U.S. hospitals are now contracting with third-party reprocessors for a number of single-use medical devices because of the proven results. The ClosureFAST reprocessing service has achieved a high level of acceptance among physicians during the first 20 months that the service has been available, and during this time we believe NES has met the industry's highest performance standards," Mr. Allmendinger said. "NES is proud to be part of this effort to reduce costs and waste and we look forward to continuing to meet the needs of U.S. vein clinics."
Vascular Solutions markets and sells the ClosureFAST reprocessing service to hospitals and clinics in the United States through Vascular Solutions' 91-person direct sales force. Subscribers to the service send their used ClosureFAST catheters directly to NES for reprocessing. NES' validated reprocessing system for ClosureFAST 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.
The new VSI 0.025" Guidewire is made from stainless steel and has a PTFE coating. It is available with a double ended-straight and 1.5mm J-tip and is 150cm in length. The 0.025" guidewire is in addition to the previously-available 0.018" guidewire that was designed for venous access in RF vein ablation procedures. Vascular Solutions now offers a full range of accessory products for the ClosureFAST radiofrequency vein ablation procedure, including 7F introducer sheath systems, an 18G echogenic needle for percutaneous entry, syringe kits and infiltration pumps for administration of local anesthesia, and a broad line of procedure packs.
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 2007. NES's facility was designed specifically to reprocess single-use devices. The process employees a high capacity reverse osmosis deionized water system for cleaning, and only environmentally safe detergents are used. NES performs all sterilization in-house using 100% ethylene oxide systems that limit waste and ensure sterility. Functional testing of each reprocessed device and heat-seal packaging is carried out in NES' Class 10,000 clean room. For more information about NES, visit the company's website at www.mdreprocess.com .
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company's product line consists of more than 75 products in three categories: catheter products, hemostat products and vein products. Vascular Solutions delivers its products to interventional cardiologists, interventional radiologists, electrophysiologists, and vein specialists through its direct U.S. sales force and international independent distributor network.
The information in this press release contains forward-looking statements that involve risks and uncertainties. Our actual 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, 2012 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, 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.
ClosureFAST is a registered trademark of VNUS Medical Technologies, Inc. Reprocessing of ClosureFAST catheters is performed by NEScientific and is not affiliated in any way with Covidien, VNUS Medical Technologies or Tyco Healthcare Group, L.P.
For further information, connect to www.vasc.com .
Vascular Solutions, Inc. James Hennen, CFO (763) 656-4352 Phil Nalbone, VP, Corp. Dev. (763) 656-4371
