SurGenTec announces FDA clearance for neurostimulation with Alara Access Needle Kit

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Alara Access Needle Kit (SurGenTec)

According to a press release, SurGenTec has received FDA clearance for a neurostimulation indication for their ALARA Neuro Access Needle Kit. The ALARA system is used for targeting and assisting in cannulating a pedicle. Targeting needles are generally the first instrument used to perforate the pedicle wall before advancing a guidewire, tap or pedicle screw.

“We are thrilled to announce the addition of the neurostimulation indication for our ALARA Neuro Needle Kit,” said Travis Greenhalgh, founder and chief executive officer of SurGenTec, “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.”

Developed and marketed by SurGenTec, the ALARA Neuro needle has an insulated depth stop that allows surgeons to choose the needle depth desired before advancing into the pedicle. Once the ALARA needle is in the pedicle it can be electrically stimulated to determine the proximity to the peripheral nerve root. By adding the neurostimulation capability, the surgeon can now determine a safe trajectory with the needle before advancing a tap or pedicle screw. This extra safety check provides surgeons with another barrier to help avoid nerve injury. SurGenTec offers various configurations of the ALARA needle that can be used with or without neurostimulation.

Upcoming conference participation

The company will have a commercial exhibit at the upcoming North American Spine Society meeting in Chicago, USA (NASS; September 25–28, 2019). Exhibit #2107.

In addition to the above mentioned ALARA Access Needle Kit, the Company’s GraftGun Universal Graft Delivery System will be showcased including the recently launched prefilled MIS cartridge options containing ViBone viable bone matrix. This novel bone matrix was developed by Aziyo Biologics as a next generation bone graft. Prefilled MIS cartridges are designed to reduce thawing time, avoid cross contamination and improve delivery performance.

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