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SurGenTec Announces FDA Clearance for New Neurostimulation Tool

18 Sep 2019

Here at SurGenTec, we strive to bring new, cutting edge technology to the spine and orthopedic community. In line with our vision of creating a better quality of life for patients with spinal or orthopedic issues, we’d like to announce that we’ve obtained FDA clearance for neurostimulation with our new ALARA™ Access Needle Kit.

What is ALARA™ Access Needle Kit?

Developed by experts on our team, the ALARA system is designed to target and assist in pedicle cannulation. Because targeting needles are typically the first tool used to perforate the pedicle wall before inserting a guidewire, tap, or pedicle screw, accuracy is of the utmost importance. That’s why ALARA includes an insulated depth stop that enables surgeons to choose their needle depth before moving into the pedicle for surgery.

“This enhancement to our system provides yet another level of safety in pedicle screw fixation and has the potential to decrease the risk of nerve injury for the patient during this intricate procedure,” says Travis Greenhalgh, SurGenTec’s Founder and Chief Executive Officer.

While methods for pedicle screw insertion vary, ordinarily a bone probe would be used to cannulate a trajectory hole. Once that is complete, the trajectory hole will then be palpated to ensure pedicle strength before the pedicle is tapped and the screw is inserted. With SurGenTec’s new ALARA system, a surgeon now has the ability to determine the safest trajectory with a needle before moving on to a tap or a pedicle screw. ALARA’s ability to be electrically stimulated helps determine its proximity to the peripheral nerve root, making tapping and pedicle screw insertion measurably safer for patients. The added measure of safety lifts a barrier that many surgeons face to help avoid nerve damage during pedicle cannulation.

In addition to offering another level of safety for spinal surgery patients, ALARA also allows surgeons to choose whether or not to use neurostimulation. We are offering various configurations of the ALARA needle that can be used either with or without neurostimulation.

We believe that ALARA is a leap forward in both patient and surgeon safety. With our GraftGun® Universal Graft Delivery System and the addition of the ALARA™ Access Needle Kit, we’re one step closer to bringing the next level of technology to the spinal and orthopedic field.