ZAP Surgical Systems, Inc. today announced it has received CE mark clearance to the new EU MDR for its ZAP-X® Gyroscopic Radiosurgery® platform. The CE mark makes it possible for healthcare providers to begin treating patients with the ZAP-X system in the European Union.
For select indications including many primary and metastatic brain tumors, stereotactic radiosurgery (SRS) is proven to be an effective alternative to invasive surgeries. As a non-invasive outpatient procedure with no surgical incision and little to no recovery period, SRS often improves patient quality of life while significantly reducing costs of care.
Developed by Dr. John Adler, CEO and founder of ZAP Surgical, and professor emeritus of neurosurgery and radiation oncology at Stanford University, the ZAP-X utilizes a modern linear accelerator to obviate historical use of live radioactive isotopes commonplace with historical SRS delivery systems. The ZAP-X system is also recognized for incorporating a first-in-kind vault-free design that typically eliminates the need for costly shielded radiation treatment rooms.
“ZAP is incredibly proud to receive the CE mark, and already planning to ship multiple systems to Europe this quarter,” said Dr. Adler. “There are millions of underserved patients worldwide which we believe can benefit from SRS each year. With a combination of ground-breaking innovations, ZAP-X looks to finally make world-class SRS accessible to the masses.”
The ZAP-X system also recently received Taiwan FDA clearance in November 2020.
Detailed system overview animations can be found at https://youtu.be/9ph-cdb5QO0.