SurGenTec, a US-based spine and orthopaedic technology company, has received approval from the US Food and Drug Administration (FDA) for its ALARA Neuro Access Needle Kit, with neurostimulation indication.

SurGenTec has developed the ALARA system for use in targeting and assisting in the process of cannulating a pedicle, where usually targeting needles are first used to perforate the pedicle wall for advancing a guidewire, tap or pedicle screw.

The ALARA Neuro needle features an insulated depth stop that facilitates the surgeons to adjust the device at desired needle depth before advancing into the pedicle.

The ALARA Neuro needle is capable of inducing electrical stimulation

Once the needle is placed in the pedicle, the proximity to the peripheral nerve root can be determined by using electrical stimulation.

With help of the neurostimulation capability, the surgeons are enabled to determine a safe trajectory with the needle before advancing a tap or pedicle screw, and the extra safety check provides an additional barrier to avoid nerve injury.

SurGenTec said that the ALARA needle is offered in different configurations, enabling the device is used with or without neurostimulation.

In addition, the company is planning to exhibit the product at the upcoming North American Spine Society (NASS) meeting in Chicago, Illinois, US.

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

“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.”

SurGenTec said that the apart from the ALARA Needle Kit, it is planning to showcase its GraftGun, a Universal Graft Delivery System, comprising the recently launched pre-filled MIS cartridge options including ViBone viable bone matrix.

Aziyo Biologics, a regenerative medicine company, has developed the novel bone matrix, as a next generation bone graft, and the pre-filled MIS cartridges are designed to reduce thawing time, avoid cross contamination and improve delivery performance.