Vascular Solutions Surpasses 50,000 Successfully Reprocessed ClosureFAST(R)
-- 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
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
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
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.
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