The BoneScalpel Access handpiece is supported by the neXus ultrasonic surgical aspirator system, a next-generation integrated ultrasonic surgical platform
The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Bioventus has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its neXus BoneScalpel Access handpiece.
The BoneScalpel Access handpiece is supported by the neXus ultrasonic surgical aspirator system, a next-generation integrated ultrasonic surgical platform that is powered by an advanced digital algorithm for enhanced versatility and control.
The neXus system incorporates all the features of soft and hard tissue removal into a single fully integrated offering.
Bioventus quality and regulatory affairs senior vice president Sharon Klugewicz said: “The BoneScalpel Access handpiece provides surgeons with a new option for confined spaces during minimally invasive surgery, enabling safe and powerful bone removal with maximum visualisation.
“In addition, BoneScalpel Access allows for en-bloc resection and the shaving and sculpting of bone, with built-in irrigation and aspiration with improved ergonomics for the end user.”
The BoneScalpel Access handpiece is designed for use in the fragmentation and aspiration of soft and hard tissue in various surgical specialties, including gynaecology and external genitalia that consists of condyloma, benign tumours and malignant primary metastatic tumours of all types.
It is also indicated for cystic lesions, including bartholin’s cysts, vestibular adenitis, inclusion cysts and sebaceous cysts.
The handpiece is suitable for use in abdominal area, including any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.
In addition, the device is indicated for use in thoracic surgery, including limited pulmonary reception such as segmetectomies, nonanatomical subsegmetectomies and metastatectomies.
The company is planning to introduce the BoneScalpel Access next year. The neXus Ultrasonic Surgical Aspirator System is already available in the US.