Less than a year after receiving its CE approval and announcing its ambitions for the international market, Sirius Medical has been going full throttle. In October 2020, the company revealed the healthy results in the clinical studies of its Pintuition system, and now, half a year later, the Eindhoven-based startup has announced it has formally received FDA approval in the US, and that its system has been used for its first international implant in the UK.
Having received the coveted 510(k) approval from the FDA, Sirius has now cleared its last major hurdle to launch its non-radioactive, wire-free, pinpoint approach to localize non-palpable breast tumors in both Europe and North America. It’s already planning its US roll-out of Sirius Pintuition and it will start providing online demonstrations to clinical teams that are interested to learn more.
“We’re extremely pleased to have received this clearance and to have the opportunity to support US clinicians and patients with our products,” says Hubert Martens, CEO and co-founder of Sirius. “This clearance highlights the team’s ability to deliver an exciting pipeline of innovative products to a global market. Sirius Pintuition is an advanced system that allows surgeons to approach the tumor more freely enabling the best possible outcome for patients.”
Only adding to Sirius’ excitement, the Dutch medtech company also revealed, in the same week, that Pintuition’s first international implant was successfully delivered in conjunction with the Royal Marsden NHS Foundation Trust in London, UK. The Royal Marsden, together with its academic partner, the Institute of Cancer Research, is the largest and most comprehensive cancer center in Europe, treating more than 59,000 patients every year.
“Preoperative seed localization allows us also to optimize the workflow between the radiology and surgical departments, which creates more flexibility in clinic and theater scheduling,” says Katherine Krupa, consultant breast surgeon at the Royal Marsden. “We’re excited to work with Sirius Pintuition as a new partner in this field.”