New metal-alloy scoring sheath CE Mark cleared for treatment of peripheral artery disease and end stage renal disease.
Salt Lake City, Utah USA, May 10, 2021. Transit Scientific announced it received CE Mark clearance in the European Union for the XO Score® Scoring Sheath Platform to facilitate dilation of stenotic material in the peripheral vasculature including popliteal, infrapopliteal, and native or synthetic arteriovenous dialysis fistulae.
XO Score is a new type of scoring and cutting technology that enables low-pressure lesion dilatation and vessel prep with a broad range of standard off-the-shelf PTA balloons. Scoring sheaths have the ability to deliver enhanced angioplasty with basic balloons while addressing the cost and performance limitations of traditional scoring or cutting technologies.
“We need novel, safe and appropriately aggressive vessel prep devices to continue fighting the increasingly difficult stenotic lesions encountered in CLI patients,” said Jihad Mustapha, MD CLI specialist at Advanced Cardiac & Vascular Center, Grand Rapids, MI. “XO Score helps fill that unmet need by enabling variable scoring depths and improved pushability which are essential when dealing with tough calcifications.”
The XO Score incorporates a unique one-piece metal-alloy exoskeleton design which 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. Future ultra-low-profile over-the-wire and rapid-exchange versions are under development for smaller vessel and coronary use.
“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,” continued Dr. Mustapha. “This is at the forefront of our fight against CLI as the disease state continues to worsen.”
This CE Mark clearance covers the XO Score platform in 65cm & 125cm working lengths with 0.25mm (0.010″), 0.35mm (0.014″), or 0.50mm (0.020″) scoring or cutting depths to enable 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,” said Greg Method, President of Transit Scientific in Park City, Utah. “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.”
Transit Scientific is a private company that designs, develops, and commercializes medical devices including the FDA-cleared and CE Mark-cleared XO Score® and XO Cross® platforms. www.XOScore.com