Hitachi receives FDA 510(k) clearance to deliver new PROBEAT-V system to Rochester-based Mayo Clinic

Mayo System Marks Hitachi’s Second U.S. System Following M.D. Anderson Cancer Center in Houston, TX

Hitachi, Ltd. (TSE: 6501, “Hitachi”) has announced it has received FDA 510(k) clearance for commercial supply of the new PROBEAT-V system, which it designed and developed for Mayo Clinic in Rochester, MN.  Treatments began in late June and the first patient treatment was completed in August 2015.

The PROBEAT-V is a state-of-the-art proton beam therapy system used to deliver Hitachi’s Discrete Spot Scanning capability to each treatment room. The 190 degree half gantries provide efficient yet spacious treatment room environments. Hitachi’s smallest treatment spot size to date enables the system to achieve highly precise treatments. In addition, installation and commissioning activities are already underway at a second Mayo facility in Phoenix, AZ, with treatments scheduled to start in the spring of 2016.

Mayo Clinic treats more than 1.3 million patients annually from all 50 states and 143 countries. Mayo Clinic has maintained its position as one of the top hospitals in U.S. News & World Report rankings for more than 20 years.

Hitachi’s PROBEAT-V Proton Beam Therapy System, is characterized by the following:

1. Treatment rooms equipped with 190 degree half gantries which provide patients with more spacious environments when compared to 360 degree full gantries
   • Patients no longer need to be positioned inside a 360 degree gantry, as all treatment angles are achieved by a 6 degree of freedom (DOF) couch.
2. Extremely precise treatments are made possible by Hitachi’s smallest spot size to date
   • A 30% smaller spot size has been achieved through refinements in nozzle design.
3. World-class, room-to-room beam matching (within 5%) technology, allow patients to be treated in any room, at any time
4. Integrated setup rooms increase patient throughput
   • Although patients’ visits may often take between 15 to 30 minutes, the time required for irradiation is usually only a few minutes. At Mayo Clinic, setup rooms allow patients to be stabilized and pre-positioned offline, optimizing treatment room utilization and shortening patients’ visits.
5. An Improved User Interface
   • The latest User Interface was co-developed with Mayo Clinic and reflects the input from a team of medical physicists and physicians at Mayo who collaborated with Hitachi engineers to improve usability from their clinical perspective.

Given the growing demand for technical and clinical advancements in the treatment of cancer, interest in proton therapy is on the rise, with more and more hospitals and cancer treatment facilities venturing into this area. Hitachi will continue to globally expand the healthcare business where proton therapy is its flagship solution, and contribute to cancer treatment around the world.

Overview of Proton Beam Therapy

Proton Beam Therapy (PBT) is an advanced form of external beam radiotherapy. Protons from a hydrogen atom are extracted and accelerated up to 70% the speed of light. Its energy is concentrated directly on the tumor while avoiding radiation dose to the surrounding healthy tissues. PBT improves the quality of life for cancer patients since the patient experiences no pain during treatment and the procedure has very few side effects compared with that of traditional radiotherapy. In most cases, patients can continue with their normal daily activities while undergoing treatment. Because there are fewer side effects, PBT is expected to expand, especially for pediatric treatment.

Overview of Spot-Scanning Irradiation Technology

Spot-scanning irradiation technology does not scatter proton beams as with conventional proton beam therapy.  Rather, it repeatedly turns a narrow proton beam on and off at high speed as it progressively changes location to irradiate entire tumor volumes.  Protons can be aimed with high precision according to the targeted tumors, even those with complex shapes, while minimizing the impact on nearby healthy tissue. Furthermore, customized equipment such as collimators and boluses are not required.

Source: http://www.hitachi.com/