Transit Scientific this week announced that it has received FDA clearance for its hydrophilic-coated XO Cross microcatheters for guidewire support, exchange and contrast media injection in the peripheral vasculature.
The 510(k) clearance includes new 2Fr XO Cross 14 microcatheters, 2.6Fr XO Cross 18 microcatheters and 3.8Fr XO Cross 35 support catheters. They can be used with standard 0.014 in., 0.018 in. and 0.035 in. guidewires in 90 cm, 135 cm, 150 cm and 175 cm working lengths.
Park City, Utah-based Transit Scientific designed the XO Cross platform with a metal-alloy exoskeleton, non-tapered shaft, and proprietary hydrophilic lubricious coating. It is designed for use in peripheral lesions but not limited to above-the-knee and below-the-knee CTOs from contralateral femoral, antegrade femoral and retrograde pedal access.
“XO Cross represents next-generation microcatheter technology, and this recent 510k clearance dramatically increases the size of Transit’s portfolio,” CEO Greg Method said in a news release. “XO Cath delivers exceptional performance as a highly-adaptive and cost-effective tool for tackling peripheral arterial disease (PAD) and critical limb ischemia (CLI). We are excited to see these devices continue to advance patient care in the US and global interventional markets.”
Microcatheters are commonly used for guidewire support, to facilitate guidewire exchanges, access distal anatomy, cross lesions, deliver therapeutic embolics and inject contrast media in complex endovascular procedures, according to the company.
“The XO Cross devices deliver unique performance and control that make them an excellent tool for crossing above- and below-the-knee lesions,” interventional cardiologist Jihad Mustapha said. “The non-tapered XO Cross shaft, lubricious coating, low crossing profile, and 1:1 torque response will be critical for workhorse performance and reducing the need for wire escalation techniques in CLI cases.”
