Surmodics this week said it received FDA 501(k) clearance for its Sublime Radial Access 0.014 Rapid Exchange Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter.
The access catheter enables below the knee access through a transradial approach by providing a working length of 250cm. Outer balloon diameters range from 2mm to 4mm with balloon lengths between 20mm and 220mm.
“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,” president and CEO Gary Maharaj said in a news release. “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.”
The Sublime dilatation catheter is compatible with a 5 Fr guide sheath and designed to prove the performance of an over-the-wire PTA catheter. Its reinforced shaft technology features flexible, kink-resistant construction and a tapered RX port transition for trackability and push through distal tortuosity.