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Innovasis receives 510K clearance and completes first surgery case with the TxHA TLIF interbody fusion device

SALT LAKE CITY, September 6, 2018 – Innovasis is pleased to announce the commercial launch of TxHA, ™ a TLIF interbody fusion device offering PEEK Optima HA Enhanced polymer.

 

Designed for use in spinal fusion procedures, the TxHA interbody device contains osteoconductive hydroxyapatite (HA) fully integrated into the polymer and exposed on all surfaces of the implant. This product follows the successful launch of Px HA (PLIF interbody) and Ax (Stand-alone ALIF) last year.

 

The first surgery was completed by Dr. Lavelle in Syracuse, NY. “The case went extremely well! The interbody and instrumentation is well designed and allowed for an easy and straightforward implantation. With this material technology you can expect better fusion rates.” said Dr. Lavelle. “HA PEEK is the future of PEEK interbodies.”

 

The Innovasis TxHA™ Transforaminal Lumbar IBF System is an intervertebral fusion

device for use in patients with degenerative disc disease (DDD) at one or two contiguous

levels of the lumbar spine (L2-S1). The implant is used to facilitate fusion in the lumbar spine and placed via a transforaminal approach. The TxHA implant also features a tapered leading edge to ease insertion, a convex profile to match anatomy, tantalum markers for improved visualization, and pyramidal teeth for migration resistance.