Tyrx wins FDA's nod to use its antibacterial envelope for neuromodulator implants

Tyrx won FDA clearance to expand the use of its next-generation antibacterial envelope for spinal cord neuromodulator implants. In doing so, it is staking claim to an infection control market with a product line that has few, if any, competitors.

The AigisRx N is a tiny pouch into which an implant is placed during surgery. Both are implanted in the patient and Aigis releases antibiotics into the body to help prevent infection. Tyrx, a New Jersey-based outfit and 2012 Fierce 15 winner, has worked quietly to expand clearances and indications for the device even as it has faced little competition. In his mass email noting the latest approval, CEO Bob White noted that "spinal cord neuromodulators represent the majority of all neuromodulator implants," and that it comes not long after the FDA also cleared the product for use with vagus nerve stimulators.

Over the summer, the company also gained the FDA's approval for a next-generation bioresorbable version of its envelope for use with a pacemaker or ICD. It now has a similar approval in Canada and Tyrx is working hard to expand the product's reach internationally. It has had FDA clearance for a partially resorbable version since 2008.

The latest clearance has given Tyrx a savvy marketing opening. With the AigisRx N now cleared for use with spinal cord neuromodulators and vagus nerve stimulators, and earlier versions cleared for cardiac implants, the company touts itself as a leader in the rollout of implantable medical devices designed to reduce surgical site infections for both neurosurgery and cardiology. And with no real competition in sight, that is clearly the case.

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