Transit Scientific today said it received CE mark clearance for its XO Score scoring sheath platform.

XO Score is designed for dilation of stenotic material in the peripheral vasculature, including popliteal, infrapopliteal and native or synthetic arteriovenous dialysis fistulae.

The scoring and cutting technology in the device enables low-pressure lesion dilation and vessel prep with standard off-the-shelf PTA balloons. The sheaths can deliver enhanced angioplasty with basic balloons.

“We need novel, safe and appropriately aggressive vessel prep devices to continue fighting the increasingly difficult stenotic lesions encountered in CLI patients,” Jihad Mustapha, CLI specialist at Advanced Cardiac & Vascular Center in Grand Rapids, Mich., said in a news release. “XO Score helps fill that unmet need by enabling variable scoring depths and improved pushability which are essential when dealing with tough calcifications.”

XO Score has a one-piece metal-alloy exoskeleton that adapts to the shape, size and length of the PTA balloon used inside it. Transit Scientific said it plants to develop ultra-low profile, over-the-wire and rapid-exchange versions for smaller vessel and coronary use in the future.

“The ability to scale this technology down to below 3Fr is especially important for treatment of pedal loop stenosis and deployment in the tibiopedal junction,” Mustapha said. “This is at the forefront of our fight against CLI as the disease state continues to worsen.”

Transit Scientific’s CE mark clearance covers the XO Score platform in working lengths of 65 cm and 125 cm with 0.25 mm, 0.35 mm and 0.50 mm scoring or cutting depths for precise dilation of calcified and fibrous lesions.

“We’ve been thrilled to see the effective low-pressure dilatation and luminal gain achieved using our XO Score platform to treat a broad range of lesion types,” president and CEO Greg Method said. “This CE Mark clearance is an important milestone and broadens our opportunity to improve patient care with scoring and cutting sheath technology in the European market.”