The company received FDA 510(k) and CE Mark clearance
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Sep. 18, 2017--
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.
1Surmodics data on file
2 Fowkes FGR, et al. Lancet
2013, 382(9901):1329-1340.
3Centers for Disease Control
and Prevention. Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.
4National Institutes of Health. What is Peripheral Artery Disease? n.d.
Web.
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Source: Surmodics, Inc.
Surmodics, Inc.
Andy LaFrence, 952-500-7000
ir@surmodics.com
