Vascular Solutions Surpasses 30,000 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
- With recent launch of 0.025" guidewire, Vascular Solutions now offers a
complete package of accessory products for RF vein ablation procedures
MINNEAPOLIS, Sept. 16, 2013 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc.
(Nasdaq:VASC) today announced that more than 30,000 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 on January 16, 2012.
Vascular Solutions today also announced the availability of its new VSI 0.025"
Guidewire for use during ClosureFAST procedures. A 0.025" guidewire is
commonly used during radiofrequency vein ablation procedures to facilitate
placement of the ClosureFAST catheter into desired treatment locations.
"Our reprocessing service for the ClosureFAST catheter represents a beneficial
opportunity for U.S. vein clinics to significantly reduce their costs and cut
down on medical waste," said Howard Root, Chief Executive Officer of Vascular
Solutions. "During the first 20 months that it has been available, our service
has established an excellent safety record, with more than 30,000 catheters
successfully reprocessed and no serious adverse patient events reported. Also,
with the launch of our new 0.025" guidewire, Vascular Solutions now offers a
full range of accessory products for RF vein ablation procedures."
Reprocessing of the ClosureFAST catheter is a service offered exclusively by
Vascular Solutions in collaboration with NES. To date, over 460 U.S. vein
practices have contracted with Vascular Solutions to have their ClosureFAST
catheters reprocessed by NES. Approximately 65% of the customers for the
reprocessing service have been entirely new accounts for Vascular Solutions.
"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 to date 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. The ClosureFAST reprocessing service has achieved a high level of
acceptance among physicians during the first 20 months that the service has
been available, and during this time we believe NES has met the industry's
highest performance standards," Mr. Allmendinger said. "NES is proud to be
part of this effort to reduce costs and waste and we look forward to
continuing to meet the needs of U.S. vein clinics."
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' 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.
The new VSI 0.025" Guidewire is made from stainless steel and has a PTFE
coating. It is available with a double ended-straight and 1.5mm J-tip and is
150cm in length. The 0.025" guidewire is in addition to the
previously-available 0.018" guidewire that was designed for venous access in
RF vein ablation procedures. Vascular Solutions now offers a full range of
accessory products for the ClosureFAST radiofrequency vein ablation procedure,
including 7F introducer sheath systems, an 18G echogenic needle for
percutaneous entry, syringe kits and infiltration pumps for administration of
local anesthesia, and a broad line of procedure packs.
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 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' 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 75 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, 2012 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 VNUS Medical Technologies, Inc.
Reprocessing of ClosureFAST catheters is performed by NEScientific and is not
affiliated in any way with Covidien, VNUS Medical Technologies or Tyco
Healthcare Group, L.P.
For further information, connect to www.vasc.com.
CONTACT: Vascular Solutions, Inc.
James Hennen, CFO
Phil Nalbone, VP, Corp. Dev.
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