Surmodics recently announced the successful first uses with 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, Andrew Niekamp, and Brian Schiro, interventional radiologists at Baptist Health’s Miami Cardiac & Vascular Institute (Miami, USA), performed the first set of procedures utilising the Sublime radial access guide sheath earlier this year. In early March, Osama A Ibrahim (Ashchi Heart and Vascular Center, Jacksonville, USA) utilised 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.
“We are thrilled and humbled to be the first facility to use the Sublime .014 RX PTA dilatation catheter, and our initial experience with this PTA catheter and the Sublime radial access guide sheath was outstanding. Delivery of the catheter was easy, even below the knee. The pushability, trackability, and crossability all were exceptional. We performed multiple inflations in the below-the-knee case and the crossing profile of the balloon was impeccable,” said Ibrahim. “Our goal at Ashchi Heart and Vascular Center is to go radial-first for all cases. The Sublime platform products we evaluated could certainly aid us in this effort.”
The Sublime radial access .014 RX PTA catheter, which received US 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 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 250cm hydrophilic coating are designed for optimal trackability and push through distal tortuosity.
The FDA-cleared Sublime radial access guide sheath is the industry’s first 5Fr sheath available in lengths up to 150cm and sets a new standard for lower extremity treatment through a transradial approach. Designed to meet the specific demands of transradial access to the periphery, the Sublime radial access guide sheath incorporates a proprietary braiding technology and high metal composition within the shaft to provide a unique balance of kink resistance, flexibility, radial strength, and torque power. The device is also available with a 6Fr outer diameter and 120cm lengths.
The Sublime radial access .014 RX PTA dilatation catheter 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. The device is contraindicated for use in the coronary arteries and the neurovasculature.
The Sublime radial access guide sheath is intended to introduce therapeutic or diagnostic devices into the vasculature, excluding the coronary and neuro vasculature.