Transit Scientific has announced CE mark clearance for its XO Score scoring sheath platform, allowing the technology to be used in the treatment of peripheral arterial disease (PAD) and end-stage renal disease (ESRD) within the European Union.
XO Score is a new type of scoring and cutting technology that enables low-pressure lesion dilatation of stenotic material in the peripheral vasculature—including popliteal, infrapopliteal, and native or synthetic arteriovenous fistulas (AVFs) in dialysis patients. It is also compatible with a “broad range” of standard, off-the-shelf percutaneous transluminal angioplasty (PTA) balloons, according to a press release from American medical device company Transit Scientific.
“We need novel, safe and appropriately aggressive vessel preparation devices to continue fighting the increasingly difficult stenotic lesions encountered in critical limb ischaemia [CLI] patients,” said Jihad Mustapha, CLI specialist at Advanced Cardiac and Vascular Center in Grand Rapids, USA. “XO Score helps fill that unmet need by enabling variable scoring depths and improved pushability, which are essential when dealing with tough calcifications.”
Scoring sheaths hold the ability to deliver enhanced angioplasty with basic balloons, while also addressing the cost and performance limitations of traditional scoring or cutting technologies.
The XO Score platform incorporates a unique one-piece, metal-alloy exoskeleton design that adapts to the shape, size, and length of the PTA balloon used inside it. This approach lets physicians select the PTA platform of their choice for use in conjunction with XO Score—potentially reducing inventory and procedural costs. In a statement, Transit Scientific also stated that future ultra-low profile over-the-wire and rapid-exchange versions of this technology are under development for smaller vessel and coronary use.
“The ability to scale this technology down to below 3Fr is especially important for the treatment of pedal loop stenosis and deployment in the tibiopedal junction,” Mustapha added. “This is at the forefront of our fight against CLI as the disease state continues to worsen.”
Transit Scientific has said its recent CE mark clearance covers the XO Score platform in 65cm and 125cm working lengths with 0.25mm (0.010″), 0.35mm (0.014″), or 0.50mm (0.020″) scoring or cutting depths, enabling precise dilation of calcified and fibrous lesions. XO Score also received FDA approval for clinical use in the USA in June 2020.
“We have 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,” said Greg Method, president and CEO of Transit Scientific. “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.”