Surmodics receives FDA 510(k) clearance for Sublime Radial Access 0.014 RX PTA Dilatation Catheter

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Surmodics receives FDA 510(k) clearance for Sublime Radial Access 0.014 RX PTA Dilatation Catheter

Press releases may be edited for formatting or style | August 06, 2020 Cardiology
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--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™ Radial Access 0.014 Rapid Exchange (RX) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter.

The Sublime Radial Access 0.014 RX PTA Catheter allows below-the-knee access through a transradial approach by providing the longest working length (250 cm) on the market. Outer balloon diameters range from 2.0 mm to 4.0 mm with balloon lengths between 20 mm and 220 mm. The product joins the previously cleared Sublime Radial Guide Sheath within the company’s Sublime Radial Access Platform and is designed to facilitate radial access for the treatment of above- or below-the-knee arteries.

“FDA 510(k) approval of the Sublime Radial Access 0.014 RX PTA Dilatation Catheter is another step forward in our strategy to become a provider of whole-product vascular solutions through the design, development and manufacturing of highly differentiated products,” said Gary Maharaj, Surmodics President and CEO. “The continued expansion of our Sublime Radial Access Platform demonstrates our commitment to developing the transradial peripheral market space through the introduction of longer, lower-profile devices that fill unmet physician and patient needs.”

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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 Although transradial access has become a mainstream technique in percutaneous coronary interventions (PCI), it has been less widely adopted in peripheral interventions due to the limited availability of purpose-designed access and therapeutic devices.

The Sublime 0.014 RX PTA Dilatation Catheter is compatible with a 5 Fr guide sheath and is designed to provide the performance of an over-the-wire PTA catheter in an RX platform. Its proprietary reinforced shaft technology with flexible, kink-resistant construction and a tapered RX port transition are designed for optimal trackability and push through distal tortuosity.

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 medical devices that are designed to address unmet clinical needs 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.

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