New York-based ultrasonic device manufacturer Misonix has received clearance from China’s State Food and Drug Administration (SFDA) to sell its bone-cutting and compression device, BoneScalpel.
The device is used to remove bone in the cervical, thoracic and lumbar spine, and also in abnormality cases.
In addition to supporting removal of en bloc bone and refined osteotomies, the ultrasonic osteotome system does not damage the soft and elastic tissues.
Misonix president and CEO Michael A McManus Jr said that after many years of clinical and regulatory efforts, in conjunction with distribution partner, Cicel, the company has been able to achieved this clearance.
"We believe the opportunity to sell the BoneScalpel in the People’s Republic of China and to work with prominent Chinese surgeons is an important step forward for our company," he added.
Misonix’s China distributor Cicel estimates that there are more than 10,000 spine surgeons in China and approximately 200,000 spine surgeries performed each year.
Cicel already distributes Misonix’s SonaStar neuro aspirator in the country.
Cicel president May Lee said that BoneScalpel provides surgeons with a much safer and more efficient approach when compared with existing technologies.
Tongji Hospital orthopaedics department Dr Feng noted that during osteotomy, especially when very close to dura, the proper protection to dura is vitally important and BoneScalpel is a great help in such cases.
The device is sold in more than 48 countries and is currently being used in the US at institutions that include Johns Hopkins, Texas Back Institute, New England Baptist Hospital and Children’s Hospital of Los Angeles.