Transit Scientific announces US FDA clearance for XO RX angioplasty platform

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Transit Scientific has announced that the XO RX 2.2Fr and XO RX 3.8Fr platform has received US Food and Drug Administration (FDA) clearance to crack, break and dilate stenoses in peripheral arteries and arteriovenous dialysis fistula-associated lesions.

“We have demonstrated XO’s rotating strut technology can crack, break, and dilate intimal and medial calcium,” said Jihad Mustapha (Advanced Cardiac and Vascular Centers for Amputation Prevention, Grand Rapids, USA). “The new 3.8Fr XO RX has a low profile and accommodates 20cm balloons, making it a good option for PAD [peripheral arterial disease] and CLI [critical limb ischaemia] disease. The lower-profile 2Fr version helps address gaps in treatment options currently available for BTK [below-the-knee], tibiopedal and pedal loop stenoses.”

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

“We have seen good results in PTA [percutaneous transluminal angioplasty]-resistant intimal hyperplastic and elastic venous lesions in patients with dialysis fistulas with the XO at low nominal or near-nominal pressures,” said Richard Saxon (Tri-City Medical, San Diego, USA). “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.”

The XO RX and XO OTW technology is designed to reduce shear and facilitate balloon rewrap by counter-rotating 90 degrees 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, the release adds.

“The XO RX platform sets new standards for low-profile, flexibility and performance,” said Jennifer Arnold, Transit’s chief operating officer. “Patients and clinicians need more tools to crack, break and dilate occlusive lesions in patients with cardiovascular disease. XO RX allows clinicians to add XO technology to hundreds of angioplasty balloons covering a wide range of diameters and lengths with just a few SKUs [stock-keeping units].”

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, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulas. However, it is not for use in the coronary or neuro vasculature, according to Transit.

XO RX is available in 2.2Fr and 3.8Fr sizes, which accommodate 1.5–7mm outer diameter standard PTA balloons of lengths from 20–200mm, reducing inventory requirements, the release also notes.


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