Vascular Solutions Receives 510(k) Clearance for Fluent™ Inflation Device
October 21 2016 - 8:30AM
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has
received 510(k) clearance from the U.S. Food and Drug
Administration for the Fluent inflation device for use during
cardiovascular procedures to create, maintain, and monitor pressure
in balloon catheters. Fluent received CE Mark clearance in August
2016 and has already begun international clinical evaluations.
Vascular Solutions expects to commence the commercial launch of
Fluent in the U.S. and Europe during the fourth quarter.
“Every angioplasty procedure requires the use of an inflation
device, and we are pleased that today’s FDA clearance to market
Fluent will allow us to expand our presence in this large, yet
competitive, market,” said Howard Root, Chief Executive Officer of
Vascular Solutions. “The internally-developed and manufactured
Fluent has design and performance characteristics that we believe
will make it a popular choice for physicians who perform a wide
range of interventional procedures, particularly when combined with
Vascular Solutions’ widely-used Guardian hemostasis valves in a
convenient interventional pack configuration.”
The Fluent inflation device features a 25cc barrel and creates
pressures up to 30 atmospheres of mercury (atm). The ergonomic
design provides a system that is easy to fill, flush, and
operate. The locking mechanism is marked to show locked and
unlocked positions. The pressure gauge glows in the dark so
that it is easily readable under low light conditions in the cath
lab.
Vascular Solutions will offer the Fluent inflation device in 10
configurations to meet a wide variety of procedural
requirements: packaged separately and as a kit including the
Guardian hemostasis valve and other angioplasty accessories.
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.
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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