FDA Clears Angioplasty Platform to Crack, Break, and Dilate Stenosis in Calcified Cardiovascular Disease and Hemodialysis Fistula

Transformative XO Angioplasty Platform Expands with Low-Profile 2.2F and 3.8F Rapid-Exchange (RX) with the Ability to Treat Up to 20cm Lesions with (1) Inflation

SALT LAKE CITY, Oct. 27, 2022 – Transit Scientific, developing medical devices to treat calcified cardiovascular disease, dilate stenosed intimal hyperplasia, and access, cross, & deliver to distal vessels, announced today the 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.

"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," said Richard Saxon, MD, FSIR of Tri-City Medical, San Diego, California 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 XO RX platform sets new standards for low-profile, flexibility, and performance," said Jennifer Arnold, Chief Operating Officer, Transit Scientific, Salt Lake City, Utah USA. "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."

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.

About Transit Scientific

Transit Scientific is focused on establishing new standards of care with differentiated proprietary devices that (1) crack, break, and dilate calcified cardiovascular plaque, (2) dilate stenosed intimal hyperplasia, and (3) access, cross, and deliver to distal vessels. Transit's XO Platforms are simple-to-use, are minimally invasive, use existing angioplasty balloons and guidewires, and preserve patient treatment options.  The XO Platform does not require new consoles, capital equipment, or complex learning curves. Transit's FDA-cleared devices include XO OTW and XO RX Angioplasty; XO Cross 014, 018, & 035 Microcatheter; and XO Cross Coronary systems. The company's XO CS Coronary Angioplasty and XO IO Embolic Delivery devices are under development and not FDA-cleared or for sale at this time.

www.TransitScientific.com