Surmodics recently announced the successful first uses in patients for two devices within its Sublime radial access platform: the Sublime radial access guide sheath and Sublime radial access .014 RX percutaneous transluminal angioplasty (PTA) dilatation catheter.
Constantino Pena, MD, Andrew Niekamp, MD, and Brian Schiro, MD, interventional radiologists at Baptist Health’s Miami Cardiac & Vascular Institute performed the first set of procedures utilizing the Sublime radial access guide sheath earlier this year. In early March, Osama A. Ibrahim, MD, an interventional cardiologist at Ashchi Heart and Vascular Center in Jacksonville, Florida, utilized the Sublime radial access .014 RX PTA dilatation catheter in multiple cases, including a below-the-knee procedure which showcased the benefits of both Sublime products.
The Sublime radial access .014 RX PTA catheter, which received Food and Drug Administration (FDA) 510(k) clearance in August 2020, allows above- or 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 device is compatible with a 5F guide sheath and is designed to provide the performance of an over-the-wire PTA catheter in an RX platform.
It is indicated for PTA dilation of peripheral vasculature stenosis in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.