Surmodics’ Sublime Radial Access .018 RX PTA Dilatation Catheter Used in First Clinical Procedures After FDA Clearance

September 29, 2021—Surmodics, Inc. announced the successful first clinical uses of the Sublime radial access .018 RX percutaneous transluminal angioplasty (PTA) dilatation catheter.

Ankur Lodha, MD, performed the first procedures at Cardiovascular Institute of the South’s office-based catheterization lab in Lafayette, Louisiana. Subsequently, Imraan Ansaarie, MD, used the device to treat patients at Advanced Endovascular Institute of St. Augustine, Florida.

“Sublime radial access RX PTA dilatation catheters will allow physicians to treat the most distal blockages in the foot with just radial access,” commented Dr. Lodha in the company’s press release. “This will help us perform more complex interventions via this approach, which was not possible prior.”

Dr. Ansaarie added, “This Sublime radial access .018 RX PTA dilatation catheter is a great addition to the current devices available for minimal arterial access lower extremity intervention procedures.”

According to Surmodics, the device is the latest addition to the company’s Sublime radial access platform, which also includes the Sublime radial access guide sheath and the Sublime radial access .014 RX PTA dilatation catheter.

FDA 510(k) clearance for the Sublime radial access .018 RX PTA dilatation catheter was received in June 2021. 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. The device is contraindicated for use in the coronary arteries and the neurovasculature, advised Surmodics.

The company stated that the Sublime radial access .018 RX PTA dilatation catheter allows above- or below-the-knee access through a transradial approach by providing a working length of 220 cm. Outer balloon diameters range from 2 to 6 mm, allowing for treatment in larger vessels. Balloon lengths are between 20 and 220 mm.

The device features the company’s shaft construction that incorporates a flexible distal segment, a supportive proximal segment, and a midshaft that transitions from supportive to flexible. The device design is intended to provide improved pushability, trackability, and crossability in an RX platform, noted the company.