Initial Cases Performed With Surmodics Sublime Radial Access Platform Devices

April 1, 2021—Surmodics, Inc. 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.

The first set of procedures utilizing the Sublime radial access guide sheath were performed earlier this year by Constantino Pena, MD, Andrew Niekamp, MD, and Brian Schiro, MD, who are interventional radiologists at Baptist Health’s Miami Cardiac & Vascular Institute in Miami, Florida.

In early March, Osama A. Ibrahim, MD, used the Sublime radial access .014 RX PTA dilatation catheter in multiple cases, including a below-the-knee procedure. Dr. Ibrahim performed his cases at the Ashchi Heart and Vascular Center in Jacksonville, Florida.

“Our initial experience with [the Sublime .014 RX PTA] catheter and the Sublime radial access guide sheath was outstanding,” commented Dr. Ibrahim in the company’s press release. “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.

“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.”

According to Surmodics, the Sublime radial access .014 RX PTA catheter received FDA 510(k) clearance in August 2020. 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 fistula. The device is contraindicated for use in the coronary arteries and the neurovasculature.

The device allows above- or below-the-knee access through a transradial approach with a long working length of 250 cm. Outer balloon diameters range from 2 to 4 mm with balloon lengths between 20 and 220 mm. The device is compatible with a 5-F guide sheath.

The Sublime radial access guide sheath received FDA clearance in 2019. The 5-F sheath is available in lengths up to 150 cm. The device is also available with a 6-F outer diameter and 120-cm length. The Sublime radial access guide sheath is intended to introduce therapeutic or diagnostic devices into the vasculature, excluding the coronary and neurovasculature, advised Surmodics.