Vertera Spine said today it won FDA 510(k) clearance for its Coalesce lumbar interbody fusion device for use in anterior, transforaminal, posterior and lateral lumbar interbody fusion procedures.
The Atlanta-based company said its newly cleared Coalesce fusion device features the company’s proprietary porous PEEK biomaterial. Vertera spine said it will be launching the Coalesce for TLIF and PLIF procedures in multiple configurations later this year.
“Based on the initial success with the Cohere Cervical porous PEEK device, we saw the need to apply this innovative technology to other spine applications. We are pleased to have received FDA clearance for Coalesce and look forward to further serving surgeons’ clinical demands for a durable fusion device that successfully osseointegrates and allows for integration to be assessed on imaging,” CEO Chris Lee said in a press release.
“I initially became convinced of porous PEEK’s clinical benefits by the successful ACDF outcomes I obtained with the Cohere device. However, I believe porous PEEK’s true value will be demonstrated with the Coalesce device in lumbar procedures where the biologic fusion environment can be more challenging, and the biomechanics more demanding on fusion devices,” Dr. Gurvinder Deol of Raleigh, N.C.’s WakeMed Health and Hospitals said in a prepared statement.
“Our latest results show that porous PEEK is able to effectively osseointegrate by forming a mechanical and biological interface with bone. Our next steps are to translate what we have learned in animal models to the clinical setting by assessing this bony ingrowth into porous PEEK on X-Ray and CT,” Dr. Ken Gall of Duke University said in prepared remarks.
Last month, Vertera Spine raised $3.1 million, according to regulatory documents. The company offered equity in exchange for a minimum investment of $2,000 and 29 investors contributed to the round, beginning Feb 7.