Vascular Solutions Surpasses 150,000 Successfully Reprocessed ClosureFAST® Catheters
September 13 2016 - 8:00AM
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: Vascular Solutions, Inc.
Phil Nalbone, VP
PNalbone@vasc.com
(763) 656-4371
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