FDA clears new guidewire controller for cardiovascular procedures

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Distal Access has announced the US Food and Drug Administration (FDA) clearance of the Spinr high-performance Guidewire Controller for use in the coronary and peripheral vasculature.

“Controlling guidewires is important to successful patient outcomes,” said Vasili Lendel, interventional cardiologist at Arkansas Heart Hospital in Little Rock, USA. “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.”

Typically, guidewires are introduced into a peripheral vessel and then advanced through the vasculature to the target organ (heart, leg, arm, or abdominal organ). From there, clinicians manoeuvre the wires through a series of forward and back movements and/or rotations. If this does not work, the wire(s) may be traded out for more advanced electromechanical systems.

“Complex electromechanical systems cost US$1,000–US$3,000+ per patient/procedure and do not work all of the time,” said Shawn Fojtik, president of Distal Access. “The Spinr is a cost-effective ‘first-use’ device to improve guidewire performance. Users connect a Spinr to 0.014”–0.038” guidewires then squeeze the handles to improve torque, control, and performance.”

Spinrs are configured with polycarbonate handles and a novel core screw drive. During use, clinicians insert a Spinr onto the proximal end of a guidewire, advance it close to the guidewire access site in the body, and tighten the cap onto the wire. Then, 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.

The Spinr is protected by issued and pending patents and FDA-cleared to manoeuvre guidewires in the coronary and peripheral vasculature during interventional and diagnostic procedures. Spinrs are not intended for use in the neurovasculature.