Transit Scientific’s XO RX 2.2 and 3.8 F Rapid Exchange PTA Devices Cleared by FDA

October 27, 2022—Transit Scientific announced FDA clearance of the XO RX 2.2 and 3.8 F rapid exchange platform to crack, break, and dilate stenoses in peripheral arteries and arteriovenous dialysis fistula-associated lesions. The XO RX 2.2 and 3.8 F accommodate 1.5- to 7-mm outer diameter standard percutaneous transluminal angioplasty (PTA) balloons of lengths from 20 to 200 mm.

The XO RX PTA system is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. It is not for use in the coronary or neurovasculature, advised the company.

According to Transit Scientific, the XO RX and XO OTW (over-the-wire) exoskeleton devices include up to 22 rotating struts that slide onto a range of off-the-shelf angioplasty balloons. During balloon inflation, the struts rotate 90° to crack, break, and dilate calcified stenotic atherosclerotic lesions, and intimal hyperplastic lesions, and can be used for vessel prep for other treatment options.

The devices’ technology is designed to reduce shear and facilitate balloon rewrap by counter-rotating 90° upon deflation. Clinicians can deliver fluids from the hub to the balloon before, during, or after inflation with XO OTW. No consoles, new capital equipment, or complex learning curve are required, noted Transit Scientific.

“We’ve demonstrated XO’s rotating strut technology can crack, break, and dilate intimal and medial calcium,” commented Jihad Mustapha, MD, in the company’s press release.

Dr. Mustapha, who is with Advanced Cardiac & Vascular Centers for Amputation Prevention in Grand Rapids, Michigan, continued, “The new 3.8-F XO RX has a low profile and accommodates 20-cm balloons making it a good option for peripheral artery disease and critical limb ischemia disease. The lower profile 2-F version helps address gaps in treatment options currently available for below-the-knee, tibiopedal, and pedal loop stenoses.”

Richard Saxon, MD, of Tri-City Medical in San Diego, California, added, “We’ve seen good results in PTA-resistant intimal hyperplastic and elastic venous lesions in patients with dialysis fistulas with the XO at low nominal or near nominal pressures. The new XO RX presents a unique and versatile option for prepping and dilating longer lesion types in patients with severe PAD during limb salvage procedures.”