FDA clears 12 new XO Cross microcatheters

241
XO Cross 14 inside XO Cross 35

Transit Scientific has announced US Food and Drug Administration (FDA) clearance of new hydrophilic-coated XO Cross microcatheters for guidewire support, exchange, and contrast media injection in the peripheral vasculature.

“The XO Cross devices deliver unique performance and control that make them an excellent tool for crossing above- and below-the-knee lesions,” said Jihad Mustapha, interventional cardiologist at Advanced Cardiac & Vascular Center in Grand Rapids, USA.  “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 CLTI [chronic limb-threatening ischaemia] cases.”

Microcatheters are commonly used to provide guidewire support, facilitate guidewire exchanges, access distal anatomy, cross lesions, deliver therapeutic embolics, and inject contrast media, during complex endovascular procedures. Hydrophilic coatings create a lubricious and slippery layer on the outside of catheters for improved navigation and tracking through tortuous vessels and lesions.

The XO Cross platform includes a metal-alloy exoskeleton, non-tapered shaft, proprietary hydrophilic lubricious coating, and large inner lumen for improved 1:1 torque, low-profile, pushability, tracking, crossing, fatigue-resistance, and angiography, a press release details.

According to Transit Scientific, XO Cross microcatheters have been safely and successfully used in challenging peripheral lesions above-the- including but not limited to above-the-knee and below-the-knee chronic total occlusions (CTOs) from contralateral femoral, antegrade femoral, and retrograde pedal access.

This 510k clearance includes new 2Fr XO Cross 14 microcatheters, 2.6Fr XO Cross 18 microcatheters, and 3.8Fr XO Cross 35 support catheters for use with standard 0.014”, 0.018”, and 0.035” guidewires in 90cm, 135cm, 150cm, and 175cm working lengths. The shorter 90cm devices support retrograde pedal and antegrade femoral access while the longer 175cm devices were designed specifically for radial access to peripheral use.


LEAVE A REPLY

Please enter your comment!
Please enter your name here