Synergy Biomedical said today that it won CE Mark clearance in the European Union for its Biosphere putty bone graft.
The company’s Biosphere putty is a synthetic bone graft that uses a type of bioactive glass in combination with a moldable phospholipid carrier.
Previous in vitro studies have shown that the bone graft product can significantly improve the healing potential of bioactive glass thanks to its spherical particle shape, Synergy Biomedical reported.
“Since its introduction, Biosphere putty has been very well received by surgeons due to its successful clinical use and excellent intraoperative handling,” president & CEO Mark Borden said in prepared remarks. “We are very pleased to receive our CE Mark and are looking forward to introducing a truly next generation, synthetic bone graft product to the European community.”
According to the graft’s indication in Europe, Biosphere putty was designed to be used to fill bony voids or gaps of the skeletal system. The product was cleared to be used for interbody and posterolateral fusion, as well as general bone defect filling.
“When it comes to selecting the best bone graft strategy for each patient, there are a wide array of options for surgeons. Biosphere putty is an elegant bone graft solution that is based on scientifically valid principles,” Dr. Erik Westerlund, from the St. Francis Hospital, said. “It applies an advanced and refined understanding of bioactive glass to drive a purposeful cellular level response and to provide an ideal physical environment for even and predictable bone ingrowth. My clinical experience with Biosphere putty over the past 2 years has been excellent, with consistently successful long-term outcomes in a wide range of spinal applications. It is an extremely thoughtful and equally versatile bone graft solution.”