Surmodics receives FDA 510(k) clearance for Sublime radial access 0.014 RX PTA dilatation catheter


SurmodicsSurmodics recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Sublime radial access 0.014 rapid exchange (RX) percutaneous transluminal angioplasty (PTA) dilatation catheter.

According to a press release, the Sublime radial access 0.014 RX PTA catheter allows below-the-knee access through a transradial approach by providing the longest working length (250cm) on the market. Outer balloon diameters range from 2–4mm with balloon lengths between 20mm and 220mm. 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 dilation 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.”

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. 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 5Fr 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.


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