Vascular Solutions Receives 510(k) Clearance for R350 Guidewire
November 24 2015 - 9:00AM
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has
received 510(k) clearance from the U.S. Food and Drug
Administration for a new and enhanced version of the R350
guidewire, an extra-long guidewire designed for use in complex
interventional procedures. The company will begin U.S. sales of the
device immediately.
The new version of the R350 will replace the original R350
guidewire that was launched in 2012 and will now be discontinued.
The design of the new version has been enhanced by the use of a
nitinol core, which provides superior flexibility and
kink-resistance in even the most extreme tortuosity, and a
hydrophilic coating on the distal 200cm for excellent
deliverability.
Initial clinical evaluations of the new version of the R350
guidewire were performed in Canada, where Vascular Solutions
received regulatory clearance earlier in 2015. Christopher
Buller, M.D., FRCPC, an interventional cardiologist at St.
Michael’s Hospital in Toronto, commented after his use of the
R350:
“With renewed emphasis on providing complete revascularization
in multivessel coronary disease, interventional cardiologists are
performing an increasing number of complex procedures including
retrograde approaches to occlusive lesions. These challenging cases
require sophisticated and specialized devices. Vascular Solutions’
extra-long R350 provides a meaningful step forward in the ability
to deliver and efficiently externalize a guidewire in retrograde
procedures. Compared to its predecessor and competitors, it has
excellent flexibility that improves conformability within the heart
and coronary arteries. Importantly, it externalized more easily
than any wire I had previously used. I expect this characteristic
will save procedural time, avoid certain procedural failure modes,
and potentially reduce patient and staff radiation exposure.”
The Vascular Solutions’ R350 guidewire is indicated for use in
percutaneous procedures to introduce and position catheters and
other interventional devices within the coronary and peripheral
vasculature. The R350 guidewire is an extra-long (350cm
length) guidewire for use with 0.014” lumen catheters. It is
designed for use in procedures that are performed with a retrograde
(against blood flow) approach to the targeted lesion.
“We are excited about the clearance of our new version of the
R350, which adds another high-performance device to our collection
of specialized tools for interventional physicians who perform
complex cases,” said Howard Root, CEO of Vascular Solutions. “The
R350 guidewire builds on our history in this area that began with
the launch of our GuideLiner catheter six years ago and continued
with the launch of our Turnpike catheter earlier this year, with
more products working through our pipeline.”
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 90 products and services 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 about Vascular Solutions that involve risks and
uncertainties. Those statements include expectations about the
company’s 2016 revenues and adjusted earnings and growth rates in
revenues and adjusted earnings. Vascular Solutions’ actual
results could differ materially from those anticipated in these
forward-looking statements. Important factors that may cause such
differences include those discussed in the company 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 the company’s new products, defense of
criminal litigation, exposure to potential shareholder litigation,
exposure to intellectual property claims and litigation,
significant variability in quarterly results, exposure to possible
product liability claims, doing business in international markets,
the development of new products by others, the company’s reliance
on the development of new products and services, constraints or
interruptions in production from key suppliers, breaches or other
failures of information technology and communications systems, the
availability of third party reimbursement, and actions by
government regulatory agencies.
For further information, connect to www.vasc.com.
Vascular Solutions, Inc.
Phil Nalbone, VP-Corp. Dev.
PNalbone@vasc.com
(763) 656-4371
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