Bonovo Orthopedics Inc. has released Cross-Fuse, a PEEK (polyether ether ketone) lateral interbody fusion cage, in China. PEEK is a biomaterial with proven biocompatibility and properties similar to that of human bone. Minimally invasive lateral interbody fusion has been gaining increasing popularity in the United States and Europe due to its less-invasive nature and proven safety and effectiveness.
The Cross-Fuse system is designed to offer a less-invasive surgical approach for the thoracolumbar spine. According to the company, the system’s features include a large graft area designed for maximum fusion potential; back-cutting teeth meant to resist migration; a bullet-tip nose for easy insertion; and highly visible tantalum markers to provide radiographic verification.
“We feel extremely privileged to be the first to introduce this new technology into China so Chinese patients can benefit from this minimally invasive surgical treatment with proven clinical results,” said Chip Bao, Ph.D., Bonovo’s CEO. “The speed of approval through the SFDA [the State Food and Drug Administration of China] of this important therapy is a testament to the expertise of the Bonovo clinical and regulatory team.”
Xifeng Zhang, M.D., director of minimally invasive surgery (MIS) at the orthopedic department at 301 Hospital in Beijing, successfully performed the first Cross-Fuse surgery at his facility with John Regan, M.D., a spine surgeon specializing in MIS.
“Many Chinese surgeons have been waiting for this new technique for a long time so they can apply this minimally invasive surgery to their patients,” said Zhang saidd. “Like in the rest of the world, MIS has become a strong trend in China. In general, Chinese patients tend to favor conservative care or less invasive surgeries. With the SFDA approval of Cross-Fuse, I am glad that Chinese surgeons finally have another minimally invasive surgical option to treat their patients with lumbar degenerative disc disease.”
Cross-Fuse is manufactured by Marquette, Mich.-based Pioneer Surgical Technology Inc., a business partner of Bonovo Orthopedics.
Bonovo Orthopedics Inc. develops orthopedic products for the Chinese healthcare market. Its corporate headquarters are in Scottsdale, Ariz., while its China office is in Beijing.