Transit Scientific’s XO Score Device Wins CE Mark Clearance

May 10, 2021—Transit Scientific announced it received European CE Mark clearance for the XO Score, the company’s scoring sheath platform to facilitate dilation of stenotic material in the peripheral vasculature including popliteal, infrapopliteal, and native or synthetic arteriovenous dialysis fistulae.

In June 2020, the company announced FDA clearance for the device.

The company advised that the CE Mark clearance covers the XO Score platform in 65-cm and 125-cm working lengths with 0.25-mm (0.010-inch), 0.35-mm (0.014-inch), or 0.50-mm (0.020-inch) scoring or cutting depths to enable precise dilation of calcified and fibrous lesions.

According to Transit Scientific, XO Score enables low-pressure lesion dilatation and vessel prep with a broad range of standard off-the-shelf percutaneous transluminal angioplasty (PTA) balloons. The XO Score incorporates a one-piece metal-alloy exoskeleton design that adapts to the shape, size, and length of the physician-chosen PTA balloon used inside it.

“We need novel, safe, and appropriately aggressive vessel prep devices to continue fighting the increasingly difficult stenotic lesions encountered in critical limb ischemia (CLI) patients,” commented Jihad Mustapha, MD, in the company’s announcement. “XO Score helps fill that unmet need by enabling variable scoring depths and improved pushability which are essential when dealing with tough calcifications.”

Dr. Mustapha, who is a CLI specialist at Advanced Cardiac & Vascular Center in Grand Rapids, Michigan, continued, “The ability to scale this technology down to below 3-F is especially important for treatment of pedal loop stenosis and deployment in the tibiopedal junction. This is at the forefront of our fight against CLI as the disease state continues to worsen.”