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Bone augmentation material cleared by the FDA
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Orthovita Inc. received 510(k) clearance from the FDA to market Cortoss Bone Augmentation Material for the treatment of vertebral compression fractures, the company announced Monday in a press release.
Cortoss is an injectable, bioactive composite that mimics the physiological properties of human cortical bone. It is reportedly the first alternative to polymethylmethacrylate (PMMA) cement that has been evaluated in a large-scale, prospective, multicenter, randomized, controlled clinical study and cleared in the United States for the treatment of vertebral compression fractures, according to the press release.
“Every year, roughly 250,000 people in the United States undergo augmentation procedures such as vertebroplasty and kyphoplasty for painful fractures in the spine. Since the inception of the vertebroplasty procedure in the mid-1980s, PMMA has been the only viable implant for vertebral augmentation,” Antony Koblish, president and CEO of Orthovita, said in the release. “Cortoss is the first FDA-cleared alternative in this product category.”
Featuring a blend of crosslinking resins and reinforcing fillers, Cortoss differs from PMMA in that it does not contain a methylmethacrylate monomer.
In April, Orthovita submitted the 2-year follow-up clinical data for patients enrolled in the company’s 256-patient multicenter study comparing the efficacy of PMMA to Cortoss. In the trial conducted under an investigational device exemption, Cortoss achieved its primary endpoint of noninferiority to the PMMA control at 24 months using a composite endpoint success rate reflecting improvement in the Visual Analog Pain Scale score, maintenance or improvement in Oswestry Disability Index function assessment, maintenance of vertebral height and alignment, and no subsequent device-related surgical intervention at the index treatment level, according to the news release.
Cortoss also reportedly demonstrated flow and fill into the existing intravertebral anatomy, rather than displacing it like PMMA, potentially reducing the volume of material required, according to the press release.
Pre-clinical in vitro and in vivo studies show that, after implantation, a bioactive response occurs at the implant’s surface, which promotes the deposition of calcium phosphate, thereby strengthening the implant-bone interface, officials noted in the press release.
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