Vascular Solutions Surpasses 50,000 Successfully Reprocessed ClosureFAST(R) Catheters
April 09 2014 - 4:05PM
-- 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
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) 656-4371
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