FDA Clears 12 New XO Cross Microcatheters

The US Food and Drug Administration (FDA) has cleared new hydrophilic-coated XO Cross Microcatheters from Transit Scientific 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 Dr. Jihad Mustapha, interventional cardiologist at Advanced Cardiac & Vascular Center in Grand Rapids, Michigan. “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.”

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 unique 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. 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 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.

“XO Cross represents next-generation microcatheter technology, and this recent 510k clearance dramatically increases the size of Transit's portfolio,” said Greg Method CEO of Transit Scientific in Park City, Utah. “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.”

Transit Scientific is a commercial stage company that designed, developed, and commercialized the XO Cross and XO Score product platforms. The FDA and CE-Mark cleared XO Score Scoring Sheath platform converts off-the-shelf peripheral transluminal angioplasty balloon into scoring & cutting devices with three different scoring & cutting depths for use in the peripheral vasculature including iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries plus obstructive lesions of native and synthetic arteriovenous dialysis fistulae. The FDA and CE-Mark cleared XO Cross Microcatheter platform includes 2F – 3.8F metal-alloy microcatheters to guide and support guidewire access, allow wire exchanges, and deliver saline or contrast agents in the peripheral vasculature.