- Reprocessing service for varicose vein ablation catheter continues to gain customers nearly five years after launch
- Excellent record of safety and reliability
- Reprocessing lowers costs and reduces medical waste for U.S. vein clinics
MINNEAPOLIS, Sept. 13, 2016 (GLOBE NEWSWIRE) — Vascular Solutions, Inc. (Nasdaq:VASC) today announced that more than 150,000 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 of 2012.
“As we approach the fifth anniversary of the launch of our novel reprocessing service for the ClosureFAST catheter, we are proud of the success of this program, which has resulted in significant cost savings and a reduction in medical waste for our customers,” said Howard Root, Chief Executive Officer of Vascular Solutions. “The benefits of a well-executed reprocessing program are clear, and we are pleased to have achieved an excellent record of safety and reliability of the reprocessed devices.”
Reprocessing of the ClosureFAST catheter is a service offered exclusively by Vascular Solutions in collaboration with NES. To date, nearly 700 U.S. vein clinics have contracted with Vascular Solutions to have their ClosureFAST catheters reprocessed by NES.
“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 and we look forward to continued success with this service.”
The ClosureFAST radiofrequency ablation catheter, which is manufactured and marketed by Medtronic, 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: “We are pleased with our achievements with the ClosureFAST reprocessing service, and we are especially gratified that the reprocessed devices have attained such a high level of acceptance among vein clinic practitioners. The success of the reprocessing program is a function of NES’s ability to demonstrate the highest industry standards of quality and product performance combined with Vascular Solutions’ extensive experience in the vein clinic market. We look forward to the ongoing collaboration.”
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 vein ablation procedures. The company provides procedure packs that are designed for either RF or laser procedures, micro-introducers and 7F mico-HV kits, 0.018” and 0.025” guidewires, 18G echogenic needles for percutaneous entry, and products 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.
Vascular Solutions markets and sells the ClosureFAST reprocessing service to hospitals and clinics in the United States through Vascular Solutions’ 100-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.
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 both a reprocessor of single-use medical devices and a manufacturer. NES is currently moving into a brand new 20,000 square-foot purpose-built facility. Founded in 2005, NES received its first 510(k) clearance in 2007 and is developing multiple 510ks in the vascular space. NES performs all reprocessing and manufacturing on site and is in the process of achieving ISO 13485 registration.
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 has launched more than 100 products that are sold 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, 2015 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 (a subsidiary of Medtronic plc). Reprocessing of ClosureFAST catheters is performed by Northeast Scientific, Inc. and is not licensed by or affiliated in any way with Covidien, Covidien LP, VNUS Medical Technologies, Inc., Tyco Healthcare Group, LP, or Medtronic plc.
For further information, connect to www.vasc.com.
CONTACT: Contact: Vascular Solutions, Inc. Phil Nalbone, VP PNalbone@vasc.com (763) 656-4371