Vascular Solutions Announces FDA 510(k) Clearance of Zigiwire(TM) Access Guidewire System
December 19 2014 - 08:00AM
- Vascular Solutions will distribute two models of the
ZigiWire guidewire system, a novel support wire system designed for
gaining vascular access in both simple and challenging peripheral
intervention
- ZigiWire is developed and manufactured by VadisWire
Corp.
- Vascular Solutions expects U.S. launch of ZigiWire in
January
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the
ZigiWire access support guidewire system has received FDA 510(k)
clearance. ZigiWire is designed to facilitate placement and
exchange of catheters during peripheral diagnostic or
interventional procedures. Vascular Solutions plans to launch
ZigiWire through its 101-member direct U.S. sales force in January
2015.
ZigiWire is manufactured for Vascular Solutions by VadisWire
Corp., a Kirkland, Washington-based company founded by
interventional cardiologist William Gray, M.D., and by veteran
medical device industry engineer and executive Ted Wulfman.
The ZigiWire guidewire support systems employ a novel method of
establishing progressive and secure support wire access into most
arterial vascular anatomy in an efficient and time saving manner.
Through any standard 0.038" compatible catheter lumen, the operator
advances a floppy-style lead wire for initial engagement of the
target vessel which is then followed by up to two additional wires
to achieve the desired level of guidewire support.
"By delivering small diameter wires consecutively into the
peripheral vasculature, ZigiWire allows an operator to more easily
access the intended vessel," said Dr. Gray, from the Cardiovascular
Research Foundation. "Several small wires in parallel provide the
cable-type support required to deliver a range of larger sheaths
and guiding catheters into challenging anatomy such as in the lower
extremities and mesenteric vasculature."
Vascular Solutions will offer two versions of ZigiWire,
consisting of a two-wire version and three-wire version. The
two-wire version is designed for use in contralateral access cases
in lower extremity vasculature. The three-wire version is
designed to provide extra support in other peripheral anatomy
procedures such as gaining access into mesenteric or other
vasculature that is tortuous in nature.
"As part of our commitment to serving the needs of
interventional physicians who perform peripheral procedures, we are
very pleased to be adding ZigiWire to our lineup of important
clinical solutions," said Howard Root, Chief Executive Officer of
Vascular Solutions. "We are excited to be collaborating with Dr.
Gray and Ted Wulfman in bringing this novel device to the
market."
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.
For further information, connect to www.vasc.com.
CONTACT: Phil Nalbone, VP
Vascular Solutions, Inc.
pnalbone@vasc.com
(763) 656-4371
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