Synergy Biomedical LLC announced it has received CE mark approval in the European Union for Biosphere Putty, the company’s next generation bone graft.
According to a company press release, the synthetic bone graft product was originally launched in the United States. The Biosphere Putty uses a form of bioactive glass combined with a moldable phospholipid carrier and has reportedly improved the healing potential of bioactive glass in vivo due to its spherical particle shape and bimodal size range.
“Since its introduction, Biosphere Putty has been well received by surgeons due to its successful clinical use and excellent intraoperative handling,” Mark Borden, PhD, president and chief executive officer of Synergy, said in the release. “We are pleased to receive our CE mark and are looking forward to introducing a truly next generation, synthetic bone graft product to the European community.”
With the CE mark approval, Biosphere Putty is to be used as a bone graft material for filling bony voids or gaps in the skeletal system. The product can be used for interbody body fusion, posterolateral fusion and bone defect filling in the extremities and pelvis. Biosphere Putty may be used alone or in combination with autograft or allograft, according to the release.