Surmodics Sublime™ Guide Sheath Receives FDA 510(k) Approval
April 23 2019 - 8:30AM
Business Wire
Guide sheath is the first of Surmodics’ family of products
designed for peripheral procedures accessed from the radial
artery
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 Sublime™ guide
sheath.
The highly flexible, proprietary Xtreme® braid-reinforced
Sublime sheath is designed to resist kinking and maximize strength
while retaining a low profile. The sheath will be available in 5Fr
and 6Fr diameters, and 120cm and 150cm lengths. The entire working
length of the guide sheath is Serene® hydrophilic coated to provide
a lubricious surface. It is preloaded with a dilator and has a
hemostasis valve with side arm for flushing. The dilators are
available with .018” and .035” guide wire compatibility.
“Surmodics continues to make progress in the development of
clinically important and innovative technologies,” said Gary
Maharaj, Surmodics President and CEO. “Our Sublime guide sheath
will set a new standard for performance and enable the delivery of
lower extremity interventions from the radial artery.”
Radial artery access has been widely adopted for use in coronary
procedures where devices have been developed to accommodate that
need. The Sublime guide sheath is intended to introduce therapeutic
or diagnostic devices into the vasculature, excluding the coronary
and neuro vasculature. Radial access offers many benefits relative
to femoral access including reduced puncture site bleeding
complications, earlier ambulation, reduced length of hospital stay,
and lower healthcare costs.1
The development of the Surmodics Sublime guide sheath is a step
forward in the Company’s strategy to be a provider of whole-product
vascular solutions, including a family of radial access products.
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; and (2) 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, 2018, 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.
References:
1. Mason P, Shah B, Tamis-Holland JE, et al. An Update on Radial
Artery Access and Best Practices for Transradial Coronary
Angioplasty and Intervention in Acute Coronary Syndrome. A
Scientific Statement from the American Heart Association. Circ
Cardiovasc Interv. 2018;11:e000035,p 1-21.
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version on businesswire.com: https://www.businesswire.com/news/home/20190423005356/en/
Surmodics, Inc.Tim Arens, 952-500-7000ir@surmodics.com
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