Transit Scientific’s New XO Cross Microcatheters Receive FDA Clearance

November 2, 2021—Transit Scientific announced the FDA clearance of 12 new hydrophilic-coated XO Cross microcatheters for guidewire support, exchange, and contrast media injection in the peripheral vasculature.

The 510(k) clearance includes the 2-F XO Cross 14 microcatheter, the 2.6-F XO Cross 18 microcatheter, and the 3.8-F XO Cross 35 support catheter for use with standard 0.014-, 0.018-, and 0.035-inch guidewires in 90-, 135-, 150-, and 175-cm working lengths. The 90-cm devices support retrograde pedal and antegrade femoral access. The 175-cm devices were designed specifically for radial access to peripheral treatments, noted the company.

According to Transit Scientific, the XO Cross platform includes a metal-alloy exoskeleton, nontapered shaft, the company’s hydrophilic lubricious coating, and a large inner lumen for improved 1:1 torque, low-profile, pushability, tracking, crossing, fatigue-resistance, and angiography. The company stated that XO Cross microcatheters have been safely and successfully used in challenging peripheral lesions including but not limited to above-the-knee and below-the-knee chronic total occlusions from contralateral femoral, antegrade femoral, and retrograde pedal access.

“The XO Cross devices deliver unique performance and control that make them an excellent tool for crossing above- and below-the-knee lesions,” commented Jihad Mustapha, MD, in the company’s announcement. “The nontapered 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 critical limb ischemia cases.” Dr. Mustapha is an interventional cardiologist at Advanced Cardiac & Vascular Center in Grand Rapids, Michigan.