ZAP Surgical Systems has announced that the company has received National Medical Products Administration (NMPA) approval in China for its ZAP-X gyroscopic radiosurgery platform.
ZAP-X was previously granted NMPA’s Chinese Medical Device Evaluation (CMDE) green pathway, an accelerated path for the examination and approval of innovative medical devices.
As part of the priority review, a preapproval clinical study was completed at PLA General Hospital 301 (PLAGH 301) in Beijing, China, which confirmed the overall patient safety and treatment efficacy of ZAP-X. PLAGH 301 is the largest hospital in China with more than 20,000 outpatient treatments per day.
“Following an intensive, multi-year effort, we are incredibly excited that the ZAP-X has finally received its regulatory approval in China,” said John Adler, founder and CEO of ZAP Surgical Systems. “In time, China will become ZAP’s largest single market, which will benefit millions of Chinese brain cancer patients.”
With its “groundbreaking” design, the ZAP-X system uses unique gyroscopic mobility to direct radiosurgical beams from hundreds of unique angles to precisely concentrate radiation on the tumour target. A company press release states that this pioneering approach supports the clinical objective of protecting healthy brain tissue and preserving patient cognitive function.
The vault-free, cobalt-free ZAP-X is also renowned for eliminating the expense of building costly, shielded radiation treatment rooms, and removing the need to maintain, secure and regularly replace live radioactive isotopes for radiation beam production, the release adds.