Korea's first heavy ion therapy device which has already been installed at Yonsei Cancer Center in Severance Hospital, obtained approval on Tuesday from the Ministry of Food and Drug Safety (MFDS) to treat patients with intractable cancers.
The import item license was granted to DK Medical Systems for its heavy ion therapy device, CI-1000.
The first heavy ion therapy device introduced in Korea is a cancer treatment medical device that destroys cancer cells without affecting normal tissues by irradiating high-energy beams generated by carbon ion acceleration.
Heavy ion therapy devices can accelerate carbon ions heavier than conventional proton therapy devices for irradiating cancer cells. It also has fewer side effects than general radiation therapy and has a higher ability to kill cancer cells than X-rays and protons, with excellent therapeutic effects.
The device utilizes the Bragg peak principle where a huge amount of radiation energy is directed toward cancer tissues using a beam, which is similar to existing proton therapy devices, except that it is more potent.
This heavy ion therapy device is a large installed medical device consisting of a synchrotron that accelerates carbon ions to high energy and a treatment room that applies heavy ions to patients.
After the approval, DK Medical Systems plans to apply for the device’s health insurance review and evaluation which is expected to first be provided without reimbursement until insurance coverage is granted.
Consequently, the exact cost of cancer treatment will be calculated after the health insurance review and evaluation are completed.
Additionally, by designating the heavy ion therapy device as a newly developed medical device, an MFDS official also stated that it will follow up with post-marketing investigations to continuously confirm its safety and effectiveness in treating various cancers.
Food and Drug Safety Minister Oh Yu-kyoung said, "We expect the first approval of the heavy ion therapy device in Korea to provide new treatment opportunities for intractable cancer patients and provide additional means for cancer treatment to physicians."