Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter
Company received FDA 510(k) clearance
Continued progress in R&D whole-product solutions pipeline
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Apr. 23, 2018--
Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and
in vitro diagnostic technologies to the healthcare industry, announced
it received U.S. Food and Drug Administration (FDA) 510(k) clearance for
its .018” Low-Profile percutaneous transluminal angioplasty (PTA)
balloon dilation catheter, designed and indicated for a broad range of
peripheral vascular applications. The product is the result of the
company’s ongoing investment in a pipeline of highly differentiated
whole-product solutions. Surmodics expects to make the product available
for distribution in the coming months.
This new low-profile product combines our most advanced balloon
technologies with Surmodics’ proprietary, low-friction, low-particulate
Serene® hydrophilic coating for superb tracking, and unmatched lesion
crossing performance, while delivering high pressures and a broad
offering ranging from 2mm to 10mm diameter.
“We are delighted to announce this latest of three recent FDA
clearances, adding further depth to our proprietary product offerings.
With the .018” Low-Profile PTA balloon catheter, we continue building
upon Surmodics’ portfolio of differentiated products that are designed
to advance the treatment of vascular disease,” said Gary Maharaj,
President and CEO of Surmodics. “This regulatory milestone adds to the
recent clearances of the Telemark™ .014” Support Microcatheter and the
.014” BTK Balloon Dilatation Catheter.”
Surmodics’ whole-product solutions strategy leverages its comprehensive,
vertically integrated design, development and high volume commercial
production capabilities at its state-of-the-art facility in Ballinasloe,
County Galway, Ireland. At this facility we control every step of the
manufacturing process to produce the highest quality medical devices
designed to address unmet clinical needs.
About Peripheral Artery Disease
Worldwide, over 200 million people have peripheral artery disease (PAD),1
a serious and underdiagnosed circulatory condition caused by build-up of
arterial plaque, most commonly in the legs. Twelve to 20 percent of
Americans over 60 years old have PAD.2 PAD increases risk of
coronary artery disease, heart attack and stroke, and can impair the
ability to walk. If left untreated, PAD can lead to gangrene and limb
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 Surmodics’ strategy to transform to a
provider of whole-product vascular solutions. 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 its subsequent reports filed with the SEC. These reports are
available in the Investors section of Surmodics' 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
Surmodics undertakes no obligation to update them in light of new
information or future events.
1 Fowkes FGR, et al. Lancet 2013, 382(9901):1329-1340.
2Centers for Disease Control and Prevention. Peripheral Arterial Disease
(PAD) Fact Sheet. n.d. Web.
3National Institutes of
Health. What is Peripheral Artery Disease? n.d. Web.
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Source: Surmodics, Inc.
Andy LaFrence, 952-500-7000