Medical devices developer Transit Scientific has received US Food and Drug Administration (FDA) clearance for its XO RX 2.2F and XO RX 3.8F Platform to crack, break, and dilate stenoses in peripheral arteries and arteriovenous dialysis fistula-associated lesions.
XO Platforms are said to be simple to use, minimally invasive, use existing angioplasty balloons and guidewires and preserve patient treatment options.
The XO RX and XO OTW (over-the-wire) exoskeleton devices, which slip onto a variety of commercially available angioplasty balloons, include up to (22) rotating struts.
The struts rotate 90 degrees during balloon inflation to crack, break and enlarge calcified stenotic atherosclerotic lesions and intimal hyperplastic lesions, Transit Scientific claimed. They can also be used to prepare vessels for other types of treatment.
Transit Scientific chief operating officer Jennifer Arnold said: “The XO RX platform sets new standards for low-profile, flexibility, and performance.
“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 100s of angioplasty balloons covering a wide range of diameters and lengths with just a few SKUs.”
By counter-rotating 90 degrees upon deflation, the XO RX and XO OTW devices are intended to reduce shear and facilitate balloon rewrap.
The medical device maker said that medical professionals can send fluids from the hub to the balloon before, during, or after inflation using XO OTW. There is no need for consoles, expensive capital equipment, or a challenging learning curve.
The XO RX Percutaneous Transluminal Angioplasty System is designed to be used with a PTA balloon to treat obstructive lesions of natural or artificial arteriovenous dialysis fistulas.
It also facilitates dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, and renal arteries.
The 2.2F and 3.8F versions of XO RX can accommodate standard PTA balloons with an outer diameter of 1.5 to 7mm and a length of 20 to 200mm, minimising the need for inventory.
