U.S. Clearance for SafeWire’s Y-Wire® 2

Sometimes the smallest innovations can make the biggest difference to operator or indeed patient. Such may be the case with device innovator, SafeWire, LLC, and its Y-Wire® 2 orthopaedic guidewire. The company has received U.S. FDA 510(k) clearance for its patented orthopedic guidewire with a distinctive split tip that is designed to prevent inadvertent advancement of the wire through bone. Upon exiting its delivery mechanism, the Y-Wire 2’s distal tips deploy to prevent further advancement. The device was designed for compatibility with a wide variety of delivery systems such as fluoroscopy, robotics and image guidance. The company will be hoping that this feature makes adoption of this innovative technology less disruptive to hospitals with established instrumentation providers.

Physician comments

Joseph Zavatsky, M.D., stated, “The Y-Wire 2 provides a solution to an ongoing issue in minimally invasive spine surgery. More importantly, it may also facilitate a return to bi-cortical fixation in the sacrum. Bi-cortical fixation in the sacrum has been the standard in open spinal surgery, but its adoption in minimally invasive surgery has been hampered by the issue of guidewire advancement.”

Company comments

Wyatt Geist, CEO of Safewire said, “Safewire is committed to the advancement of minimally invasive instrumentation for spine surgeons and their patients. FDA clearance of the Y-Wire is a significant milestone, and we are excited to provide the surgical community with a guidewire designed to mitigate inadvertent advancement during minimally invasive spinal surgery. “

Source: SafeWire, LLC

Share your thoughts

Your email address will not be published. Required fields are marked *