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FDA Clears New Guidewire Controller for Cardiovascular Procedures

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FDA Clears New Guidewire Controller for Cardiovascular Procedures

02/05/2015

<p><img alt="" src="/files/uploads/SPINR.png" style="float:right; height:252px; width:300px" />February 4, 2015 — PARK CITY, UTAH – Distal Access announced the FDA cleared the SPINR High-Performance Guidewire Controller for use in the coronary and peripheral vasculature.</p>

<p>“Controlling guidewires is important to successful patient outcomes,” said Dr. Vasili Lendel, Interventional Cardiologist at Arkansas Heart Hospital in Little Rock, Arkansas. “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.”&nbsp; &nbsp;</p>

<p>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 maneuver 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.<img alt="" src="http://www.cathlabdigest.com/files/Screen%20Shot%202015-02-09%20at%2011…; style="border:0px; box-sizing:border-box; float:left; height:323px; max-width:100%; vertical-align:middle; width:600px" /></p>

<p>“Complex electromechanical systems cost $1,000 - $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.”</p>

<p>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 the SPINR close to the guidewire access site in the body, and tighten the SPINR 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.&nbsp;&nbsp;&nbsp;&nbsp;</p>

<p>The SPINR is protected by issued and pending patents and FDA cleared to maneuver guidewires in the coronary and peripheral vasculature during interventional and diagnostic procedures. SPINRs are not intended for use in the neurovasculature.</p>

<p>Call 1-954-534-9345 or visit&nbsp;<a href="http://www.distalaccess.com/&quot; style="box-sizing: border-box; color: rgb(0, 33, 87); text-decoration: none; background: transparent;">www.DISTALACCESS.com</a>&nbsp;for more information about the SPINR. The SPINR is currently being distributed by Control Medical Technology.</p>

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