FDA Clears Distal Access's Spinr Guidewire Controller

February 5, 2015—Distal Access announced that the US Food and Drug Administration cleared the company’s Spinr high-performance guidewire controller for use in the coronary and peripheral vasculature during interventional and diagnostic procedures. Spinrs are not intended for use in the neurovasculature. The Spinr is distributed by Control Medical Technology.

According to the company, the Spinr is a cost-effective, first-use device that is connected to 0.014- to 0.038-inch guidewires to improve guidewire performance. The Spinr device is configured with polycarbonate handles and a core screw drive. Clinicians insert a Spinr onto the proximal end of a guidewire and advance it close to the guidewire access site in the body. The Spinr cap is then tightened onto the wire. The clinician can squeeze and release the front handle to rotate-oscillate the guidewire with improved torque, control, and performance. No motors or complex electromechanical mechanisms are required, noted Distal Access.

Vasili Lendel, MD, commented in the company’s press release, “Controlling guidewires is important to successful patient outcomes. Basically, if a guidewire cannot cross a lesion, we may not be able to treat the problem. Devices that help guidewires access and cross lesions can help improve procedure safety and effectiveness.” Dr. Lendel is an interventional cardiologist at Arkansas Heart Hospital in Little Rock, Arkansas.