-- 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
-- Vascular Solutions offers a complete package of accessory products for ClosureFAST vein ablation procedures
MINNEAPOLIS, April 9, 2014 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that more than 50,000 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 in January 2012.
"The benefits and reliability of our reprocessing service for the ClosureFAST catheter are extremely clear, and as a result a growing number of U.S. vein clinics are adopting this service as a way to significantly reduce their costs and cut down on medical waste," said Howard Root, Chief Executive Officer of Vascular Solutions. "During more than two years since this novel service was launched, we have demonstrated an excellent safety record, with more than 50,000 catheters successfully reprocessed and no serious adverse patient events reported."
Reprocessing of the ClosureFAST catheter is a service offered exclusively by Vascular Solutions in collaboration with NES. To date, more than 500 U.S. vein practices have contracted with Vascular Solutions to have their ClosureFAST catheters reprocessed by NES.
"Our reprocessing partner, NES, has done an excellent 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 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. Since the ClosureFAST reprocessing service was launched more than 26 months ago, it has achieved a high level of acceptance among physicians as we have demonstrated the ability to meet the highest performance standards."
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's 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.
In addition to supporting its Vari-Lase® laser ablation product line and offering the ClosureFAST reprocessing service, Vascular Solutions offers a full range of accessory products that are needed to perform both RF- and laser-based procedures. The company provides procedure packs that are designed specifically for either RF or laser procedures, micro-introducers and 7F Micro-HV kits, 0.018" and 0.025" guidewires and the Auto-Fill® Syringe and Klein Pump kits for administering tumescent anesthesia. Vascular Solutions also sells a line of disposable vein hooks for use in phlebectomy procedures and the Veinsite® system used to visualize veins beneath the skin surface.
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 employs 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's 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 80 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, 2013 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 Covidien LP Limited Partnership. Reprocessing of ClosureFAST catheters is performed by Northeast Scientific and is not affiliated in any way with Covidien.
For further information, connect to www.vasc.com.
CONTACT: Phil Nalbone, VP-Corp. Dev. PNalbone@vasc.com (763) 656-4371Source:Vascular Solutions, Inc.