Surmodics Announces Global Approvals of .014" Low-Profile PTA Balloon Dilation Catheter
September 18 2017 - 8:00AM
Business Wire
The company received FDA 510(k) and CE Mark
clearance
Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical
device and in vitro diagnostic technologies to the healthcare
industry, announced it has received U.S. Food and Drug
Administration (FDA) 510(k) and CE Mark clearance for its .014”
low-profile percutaneous transluminal angioplasty (PTA) balloon
dilation catheter, designed for peripheral angioplasty procedures.
The company is making this product available for distribution in
the coming months.
Surmodics .014” PTA balloon catheter offers best-in-class
deliverability and lesion crossing by leveraging the company’s
proprietary Serene® hydrophilic coating, unmatched for low friction
and particulates.1 The company’s proprietary balloon and catheter
technology, combined with Surmodics’ advanced processes, ensures
ultra-low tip entry and crossing profile with smooth transitions,
to achieve best-in-class product performance.
“Surmodics is focused on providing next-generation devices to
address the growing need for minimally invasive treatment of
peripheral artery disease,” said Gary Maharaj, President and CEO of
Surmodics. “We’re confident this highly deliverable, low-profile
PTA catheter will provide physicians an effective new tool for
accessing and crossing even the most complex peripheral
lesions.”
The development of the Surmodics .014” low-profile PTA catheter
is a step forward in the company’s strategy to be a provider of
whole-product vascular solutions for its medical device customers.
Following acquisitions of Creagh Medical and NorMedix, Surmodics
now has complete capabilities for design, development and
high-volume manufacturing of a wide variety of highly
differentiated balloon catheter and specialty catheter
solutions.
With a complete suite of in-house capabilities at its
state-of-the-art facility in Ballinasloe, Ireland, Surmodics
controls every step of the manufacturing process to produce
high-quality, reliable balloon catheters under rigorous testing.
Surmodics’ portfolio of balloon technologies includes the
highest-pressure conventional balloons.1
About Peripheral Artery Disease
Worldwide, over 200 million people have peripheral artery
disease (PAD),2 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.3 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 amputation.4
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) tests
and microarrays. Following two recent acquisitions of Creagh
Medical and NorMedix, the Company is executing a key growth
strategy for its medical device business by expanding to offer
total intravascular product solutions to its medical device
customers. The combination of proprietary surface technologies,
along with enhanced device design, development and manufacturing
capabilities, enables Surmodics to significantly increase the value
it offers with highly differentiated intravascular solutions
designed and engineered to meet the most demanding requirements.
With this focus on offering total solutions, Surmodics’ mission
remains to improve the detection and treatment of disease.
Surmodics is headquartered in Eden Prairie, Minnesota. For more
information about the company, 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 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,
2016, 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 future events.
1 Surmodics data on file2 Fowkes FGR, et al. Lancet 2013,
382(9901):1329-1340.3 Centers for Disease Control and Prevention.
Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.4 National
Institutes of Health. What is Peripheral Artery Disease? n.d.
Web.
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version on businesswire.com: http://www.businesswire.com/news/home/20170918005186/en/
Surmodics, Inc.Andy LaFrence, 952-500-7000ir@surmodics.com
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