Sirius Medical announced that it received CE Mark approval for its Sirius Pintuition non-radioactive tumor localization system.
Eindhoven, the Netherlands-based Sirius said in a news release that it intends to launch the Pintuition system in September of this year, with the first systems currently in production. The company intends to implement the systems in hospitals in the Netherlands, the U.K. and other countries in Europe in 2020 with an eye on the U.S. in 2021.
The Pintuition system is an alternative to traditional surgical localization systems that rely on anchor wires or radioactive seeds, offering a precise, easy-to-use and affordable way to improve hospital workflow. The Pintuition seed can be placed up to 180 days before surgery to mark a target within soft tissue.
During surgery, the Pintuition reusable probe, which is compatible with metal instruments commonly used during surgery, offers real-time feedback and directional guidance to the marked tissue
“We are pleased to have achieved this important milestone with the help and input of many physicians and engineers,” Sirius Medical CEO Hubert Martens said in a news release. “We are very excited to make our cost-efficient localization system for soft tissue tumors available to hospitals in Europe. This is great news for surgeons and radiologists as our system provides them with more freedom to apply their skills and deliver the best possible outcome for patients.”