News
Article
FDA Clears INTRABEAM 700 as Supportive Device for Intraoperative Radiation Therapy
Author(s):
Key Takeaways
- ZEISS INTRABEAM 700 offers precise, low-energy X-ray delivery to tumor beds, enhancing neuro-oncology and breast cancer treatments.
- The system integrates robotic precision, digital workflow efficiency, and connectivity, improving surgical procedures.
The ZEISS INTRABEAM 700 advances neurosurgical oncology by enabling precise intraoperative radiotherapy delivery, improved workflow efficiency, and enhanced collaboration between neurosurgeons and oncologists.
Christopher Cifarelli, MD, PhD
According to a recent announcement, the FDA has given clearance to ZEISS Medical’s INTRABEAM 700, an advanced intraoperative radiotherapy (IORT) platform developed to deliver precise, low-energy X-ray radiation directly to tumor beds during surgery. It holds several different advantages in neuro-oncology, such as precision and control, reduced need for external radiotherapy, and workflow efficiency.1
Building upon ZEISS’s established INTRABEAM technology, this next-generation system integrates robotic-assisted precision, digital-first workflow efficiency, and seamless connectivity to enhance surgical procedures, particular in neuro-oncology and breast cancer treatments. A key feature of the INTRABEAM 700 is its robotic SMART Stand, which allows for both rapid and finely controlled movements, ensuring accurate applicator placement within the surgical cavity.
"Based on our established INTRABEAM platform, the newly developed ZEISS INTRABEAM 700 marks the next major step on our path to shaping the oncology workflows of tomorrow," Christian Schwedes, head of the Neuro- and Spine Surgery Sector at ZEISS, said in a statement.1 "It is especially designed for a precise, structured and risk-adapted treatment of brain tumors."
Schwedes added, "From smart robotic positioning of the system, a more efficient workflow before and during the application, to bringing the system into the 21st century when it comes to digitalization and connectivity, the ZEISS INTRABEAM 700 will support the efficient and seamless collaboration between neurosurgery and oncological therapy."
Once the SMART Stand is positioned, active vibration damping maintains stability, facilitating consistent radiation delivery. The system employs sterile, single-use SMART Spherical Applicators and a Spherical Sizer Set, both equipped with RFID technology, to streamline the intraoperative processes and eliminate the need for sterilization. Complementing the hardware is the Radiance treatment planning software, which enables preoperative simulation and real-time adjustments, contributing to a more predictable and efficient treatment workflow.
READ MORE: Argatroban Plus Dual Antiplatelet Treatment Proves Effective in Branch Atherosclerosis Disease
As digitalization transforms surgical oncology, the ZEISS INTRABEAM 700 offers seamless integration into hospital systems, enabling faster workflows, streamlined data management, and applicator recognition through embedded RFID technology. Designed to enhance intraoperative efficiency, the platform reflects ZEISS' commitment to innovation in cancer therapy. The INTRABEAM 700 is already being utilized in large clinical studies investigating intraoperative radiotherapy for brain tumors, with published data available, and additional research underway in breast cancer.
"The new incarnation of the INTRABEAM 700 really gives you more range of motion in the delivery of the applicator to the cavity. It gives you precision in how movements can be made inside of the resection cavity by the applicator," Christopher Cifarelli, MD, neurosurgeon at West Virginia University, said in a statement.1
The INTRABEAM platform is currently being evaluated in several large-scale clinical trials investigating IORT in various cancers. These include the phase 3 INTRAGO-II trial of glioblastoma (data publication expected in 2026), phase 2 INTRAMET study of brain metastases (results expected in 2026), phase 3 TARGIT-E study of elderly patients with breast cancer (publication due in 2025), and TARGIT-US, a phase 4 trial of patients with breast cancer undergoing breast-conserving surgery (results expected in 2027).2
