Transit Scientific Gets FDA’s 510(k) Clearance for Microcatheters

Transit Scientific has received the FDA’s 510(k) clearance for 12 of its hydrophilic-coated XO Cross microcatheters.

"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, Mich., according to a Transit Scientific statement. “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 CLI cases," he added, referring to critical limb ischemia.

The devices are intended for guidewire support, exchange and contrast media injection in the peripheral vasculature, according to the Park City, Utah-based company.