Vascular Solutions Marks 5,000th Successfully Reprocessed ClosureFAST(R) Catheter
- Reprocessing of popular vein treatment catheter results in significant cost savings and medical waste reduction for vein practices
- Nearly 300 clinics have contracted to have their ClosureFAST catheters reprocessed since launch of the service on January 16, 2012
MINNEAPOLIS, July 12, 2012 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (VASC) today announced that over 5,000 ClosureFAST vein ablation catheters have been reprocessed by its reprocessing partner, Northeast Scientific, Inc. (NES), since Vascular Solutions launched the reprocessing service on January 16, 2012.
"Since we began offering the reprocessing service in collaboration with NES less than six months ago, NES has demonstrated an efficient and thorough reprocessing system that has more than met the significant market demand," said Howard Root, Chief Executive Officer of Vascular Solutions. "Our customers have been very pleased with the performance of the reprocessed catheters and along the way they have saved a significant amount of money and reduced the amount of medical waste by electing to have their ClosureFAST catheters reprocessed for a second use."
To date, nearly 300 U.S. vein practices have contracted to have their ClosureFAST catheters reprocessed, which is a service offered exclusively by Vascular Solutions in the U.S. in collaboration with NES. Approximately 65% of the customers for the reprocessing service represent entirely new accounts for Vascular Solutions. "The ClosureFAST reprocessing service has allowed us to offer a valuable service to our existing customers, while also allowing us to significantly expand our footprint in the vein treatment market," Mr. Root said. Vascular Solutions continues to expect the ClosureFAST reprocessing service to generate between $3 million to $5 million in revenue during 2012.
"Reprocessing has become 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," Mr. Root said. "We are very pleased with the early success of our reprocessing service for the widely-used ClosureFAST catheter."
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 has proven to be an effective way for hospitals and clinics to cut down on waste and reduce operating costs while not sacrificing quality or patient safety. Regulators hold third-party processors such as NES to very high quality standards, and we are proud to have completed 46 tests to document that our reprocessed ClosureFAST catheters meet the industry's highest standards for performance. We are also very proud of the high level of acceptance that has been demonstrated with the first 5,000 ClosureFAST devices we have reprocessed, and we have the systems and capacity in place to dramatically expand our throughput, as we intend to do."
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. After reprocessing is completed, customers receive those same catheters back, ready for a second use. 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 all quality standards are met.
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 using100% 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 over 60 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, 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, 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 Tyco Healthcare Group, L.P., a division of Covidien. Vascular Solutions' reprocessing service for the ClosureFAST catheter is not licensed by or associated with Covidien.
For further information, connect to www.vasc.com .
CONTACT: James Hennen, CFO Phil Nalbone, VP Vascular Solutions, Inc. (763) 656-4300Source: Vascular Solutions, Inc. 2012 GlobeNewswire, Inc.