Vascular Solutions Launches PolarCath(TM) Peripheral Dilatation System
March 16 2015 - 9:00AM
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has
commenced sales of the PolarCath peripheral dilatation system in
the United States in collaboration with NuCryo Vascular LLC, the
manufacturer of the product.
As previously announced, Vascular Solutions entered into an
agreement with NuCryo in November of 2014 to serve as the exclusive
U.S. distributor of the PolarCath product line. Vascular Solutions
is projecting between $3 million to $5 million in PolarCath sales
during 2015.
The PolarCath peripheral dilatation system is indicated for use
in dilating stenoses in the peripheral vasculature (iliac, femoral,
popliteal, infrapopliteal, renal, and subclavian arteries) and for
the treatment of obstructive lesions of polytetrafluoroethylene
(PTFE) access grafts or arteriovenous dialysis fistulae. The
PolarCath system is also indicated for post-deployment stent
expansion of self-expanding peripheral vascular stents.
"With more than a decade of extensive clinical experience,
PolarCath has an important role in the treatment of peripheral
arterial disease," commented Howard Root, Chief Executive Officer
of Vascular Solutions. "The product is a natural fit for our U.S.
direct sales force and our focus on meeting the needs of
interventional vascular physicians. Beginning today, we have
available the wide range of 0.014" guidewire-compatible PolarCath
balloon catheters which target mainly below-the-knee interventions.
Later this year, we will add the 0.035" guidewire-compatible
versions of the PolarCath balloon catheters which generally target
above-the-knee interventions."
The PolarCath peripheral dilatation system consists of a balloon
catheter, an inflation unit, and a nitrous oxide cartridge. Use of
the PolarCath system simultaneously dilates and modifies
atherosclerotic plaque. Once delivered to the lesion, the PolarCath
balloon is inflated with nitrous oxide gas, which cools the vessel
wall during a 20-second treatment at -10°C. The PolarCath
peripheral dilatation system was invented by Dr. James Joye, a
prominent interventional cardiologist focused on pioneering new
vascular treatments.
"Balloon cryoplasty has been shown in clinical studies and in
everyday practice to be an important option for treating peripheral
arterial disease, which in patients with severe PAD can lead to
below-the-knee amputations," Dr. Joye said. "The controlled cooling
of the plaque and artery wall provides three potential benefits:
uniform vessel dilation with less vessel trauma; reduced vessel
wall recoil; and induction of apoptosis, promoting the natural cell
death of the smooth muscle cells that otherwise proliferate to
cause restenosis."
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, 2014 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.
For further information, connect to www.vasc.com
About PolarCath and NuCryo Vascular
The PolarCath system, which received its first FDA clearance in
2002, was developed by CryoVascular, Inc., a company formed by Dr.
Joye and collaborators. In 2005, CryoVascular was acquired by
Boston Scientific, which discontinued manufacturing PolarCath at
the end of 2012. NuCryo Vascular was formed by Dr. Joye and several
of the former CryoVascular executives and employees for the purpose
of acquiring PolarCath and resuming manufacturing of the device.
NuCryo Vascular has established a manufacturing facility for
PolarCath in Sunnyvale, CA.
For further information, connect to www.nucryovasc.com
CONTACT: Vascular Solutions, Inc.
Phil Nalbone, VP-Corp. Dev.
PNalbone@vasc.com
(763) 656-4371
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