Medtech startup Sirius Medical has crossed a big hurdle. The Eindhoven-based company has received CE approval for its debut product called the Pintuition, a non-radioactive localization system. The system, which is designed to assist and improve breast cancer surgery, offers an affordable and easy-to-use alternative to traditional surgical localization systems that rely on anchor wires or radioactive seeds planted into soft tissue.
The Sirius Pintuition system uses a seed, a small magnet encapsulated in high-grade biocompatible titanium, that can be placed up to 180 days before the surgery to mark a target within soft tissue. During surgery, the Sirius Pintuition Probe, with a 50 mm detection range, provides highly accurate, real-time feedback and directional guidance to the marked tissue. The probe is reusable and compatible with metal instruments that are commonly used during surgery.
With the goal of transforming the way tumors are localized during surgery, Sirius turned to Dutch electronics and embedded software specialist 3T for assistance. By capitalizing on 3T’s technical know-how in measurement and control technology and its expertise in developing medical devices, in accordance with the stringent European health and safety standards, the startup has now received the coveted CE marking and can focus on the European commercial launch, expected in September 2020, with launch in the US anticipated in 2021.
“We’re pleased to have achieved this important milestone with the help and input of many physicians and engineers,” says Hubert Martens, CEO of Sirius Medical. “We’re 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.”