Transit Scientific, a provider of medical devices to treat calcified cardiovascular disease, dilate stenosed intimal hyperplasia, and access, cross, and deliver to distal vessels, said its XO RX 2.2F and XO RX 3.8F Platform received FDA clearance to crack, break and dilate stenoses in peripheral arteries and arteriovenous dialysis fistula associated lesions.
"We've demonstrated XO's rotating strut technology can crack, break, and dilate intimal and medial calcium," said Jihad Mustapha MD, FACC, FSCAI of Advanced Cardiac & Vascular Centers for Amputation Prevention in Grand Rapids, Michigan USA. "The new 3.8F XO RX has a low profile and accommodates 20 cm balloons making it a good option for PAD and CLI disease. The lower profile 2F version helps address gaps in treatment options currently available for BTK, 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. 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.
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 XO RX Percutaneous Transluminal Angioplasty 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 fistulae. Not for use in the coronary or neuro-vasculature.
XO RX is available in 2.2F and 3.8F which accommodate 1.5 – 7mm outer diameter standard PTA balloons of lengths from 20-200mm, reducing inventory requirements.