Surmodics Receives 510(K) Clearance for Telemark™ Coronary/Peripheral Support Microcatheter from the U.S. Food and Drug Administration
Unique Coiled/Braided Shaft Technology Offers Superior Crossability
Proprietary Hydrophilic Coating Provides Best-in-Class Lubricity
and Low Particulates
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Jan. 22, 2018--
Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and
in vitro diagnostic technologies to the health care industry, announced
it has received U.S. Food and Drug Administration (FDA) 510(k) clearance
for its Telemark™ .014” coronary and peripheral support microcatheter.
The Company is making this product available for U.S. distribution in
the coming months.
The Telemark support microcatheter offers superior crossability
for complex coronary and peripheral lesions. The microcatheter combines
Surmodics’ Xtreme™ composite shaft technology with a high-performance
Pristyne™ hydrophilic coating that together provide exceptional
deliverability, kink resistance and lesion crossing. Surmodics’ Pristyne
hydrophilic coating offers best-in-class lubricity and low particulates.
The Telemark microcatheter’s tapered profile design has an outer
diameter ranging from 2.6 Fr to 1.4 Fr for effective penetration of
tough, calcified lesions.
“This is another example of our progress and our commitment to
developing highly differentiated vascular product solutions,” said Gary
Maharaj, President and CEO of Surmodics. “Our Telemark
microcatheter incorporates advanced technology that enables an
exceedingly low crossing profile, excellent trackability and resistance
to kinking, even in complex coronary and peripheral lesions, where there
is still a great market need.”
The development of the SurmodicsTelemark .014” support
microcatheter is a step forward in the Company’s strategy to be a
provider of whole-product vascular solutions for its medical device
customers. Surmodics has complete capabilities for design, development
and high-volume manufacturing of a wide variety of highly differentiated
balloon catheter and specialty catheter solutions.
About Surmodics, Inc.
Surmodics is the global leader in surface modification technologies for
intravascular medical devices and a leading provider of chemical
components for in vitro diagnostic (IVD) immunoassay tests and
microarrays. Surmodics is pursuing highly differentiated whole-product
solutions that are designed to address unmet clinical needs for its
medical device customers and engineered to the most demanding
requirements. This key growth strategy leverages the combination of the
Company’s expertise in proprietary surface technologies, along
with enhanced device design, development and manufacturing capabilities.
The Company mission remains to improve the detection and treatment
of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For
more information, visit www.surmodics.com. The
content of Surmodics’ website is not part of this press release or part
of any filings that the company makes with the SEC.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that
are not historical or current facts, including statements about beliefs
and expectations regarding the Company’s strategy to transform to a
provider of whole-product vascular solutions, are forward-looking
statements. Forward-looking statements involve inherent risks and
uncertainties, and important factors could cause actual results to
differ materially from those anticipated, including (1) our ability to
successfully develop, obtain regulatory approval for, and commercialize
our proprietary products; (2) our ability to achieve expected benefits
from our acquisitions; and (3) the factors identified under “Risk
Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the
fiscal year ended September 30, 2017, and updated in our subsequent
reports filed with the SEC. These reports are available in the Investors
section of our website at www.surmodics.com
and at the SEC website at www.sec.gov.
Forward-looking statements speak only as of the date they are made, and
we undertake no obligation to update them in light of new information or
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Source: Surmodics, Inc.
Andy LaFrence, 952-500-7000