Transit Scientific’s Cutting-Edge Scoring Sheath Platform Earns CE Mark Approval
May 20, 2021
Transit Scientific has announced that its XO Score® Scoring Sheath Platform has received CE Mark clearance in the European Union for treatment of peripheral artery disease and end stage renal disease. Last year, the company announced FDA clearance for the device.
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 step forward in making this innovative technology available in Europe to improve patient care,” said Kelvyn Cullimore, president and CEO of BIoUtah.
(PRNewsfoto/Transit Scientific)
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.