Novalis Shaped Beam Surgery System
Brainlab Ag
FDA Clearance Information
The Novalis Shaped Beam Surgery System was cleared by the FDA via the 510(k) pathway on November 3, 2000. It is manufactured by Brainlab Ag and classified as a Class 2 device under product code MUJ.
What It Is
FDA-Cleared Indications
- Used to deliver stereotactically directed radiation therapy to localized lesions.
- Used for precise radiation treatment of intracranial tumors and other lesions when treatment planning and beam shaping are required.
Clinical Applications
- Stereotactic radiosurgery for selected brain tumors and intracranial lesions.
- Focused radiation treatment for brain metastases.
- Radiation treatment for selected glioblastoma or other localized brain tumors.
- Stereotactic radiation treatment of selected vertebral lesions, including vertebral hemangiomas.
Reported off-label uses
- Stereotactic radiation treatment of selected extracranial tumors, depending on the system configuration and institutional protocol.
- Stereotactic radiation treatment for selected recurrent tumors or lesions after prior surgery or radiation.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- This is a radiation-delivery system, not an implanted device; treatment planning depends on lesion size, location, target movement and prior radiation exposure.
- The system uses imaging, patient immobilization or image guidance, and customized beam shaping to focus radiation while limiting exposure to nearby tissue.
- MRI may be used for treatment planning, but MRI safety depends on the specific immobilization, tracking and accessory components; the system itself should not be assumed to be MRI safe without site-specific verification.
- Treatment may require a rigid frame, mask or other immobilization method, depending on the clinical application.
- Contraindications and limitations include inability to maintain the required treatment position, excessive lesion size or number, unsafe proximity to sensitive structures, and clinical conditions for which focused radiation is inappropriate.
Frequently Asked Questions
What are the clinical indications for Novalis Shaped Beam Surgery System?
The device is indicated for treating brain metastases, glioblastomas, and vertebral hemangiomas, particularly when traditional surgery is not an option.
What outcomes have been reported in clinical studies?
Studies report effective tumor control and symptom improvement in patients with brain metastases and vertebral hemangiomas treated with the Novalis system.
What complications have been reported?
Reported complications include radiation-induced side effects such as fatigue and skin irritation, though these are generally manageable with proper care.