The FDA cleared 3D-printed and patient specific accessory devices will support and expand clinical use of OssDsign's patient specific cranioplasty implant
Image: The US FDA’s Centre for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
Swedish medical technology company OssDsign has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Cranial PSI Accessories.
The Cranial PSI Accessories comprise of 3D-printed and patient specific accessory devices, which support and expand clinical use of the company’s patient specific cranioplasty implant already approved by the FDA.
OssDsign Cranial PSI Accessories enable cranial reconstruction in single stage procedure
OssDsign Cranial PSI Accessories, which are designed to make cranial reconstructions safe and easy, will help provide new solutions for patients requiring complex cranial reconstructions.
The new accessories, along with OssDsign’s new implant technology, will help US neurosurgeons to remove bone tumours or diseased bony tissue and conduct cranial reconstruction in a single stage procedure.
The company is already offering Cranial PSI Accessories for neurosurgeons in the European market.
OssDsign has developed an advanced set of accessory products ranging from anatomical models to surgical guides and intraoperative implant trials, as part of its market expansion strategy.
OssDsign CEO Anders Lundqvist said: “I think it’s safe to say that we are the only company with the technology platform and clinical competence necessary to produce implant solutions suitable for some of these extremely complex cranial reconstructions.
“These accessory products combined with our novel implant technology fulfil an unmet medical need, enabling treatment of very complex patient groups. Involvement with these complex cases have also resulted in new innovations, IP and product development opportunities.”
OssDsign is involved in the development and manufacturing of regenerative implants for improved healing of bone defects.
The company offers a range of patient specific implants and surgical solutions for cranial and facial reconstruction.
In August this year, the company has filed for a regulatory approval of OssDsign Cranial in Japan.
Once approved, OssDsign Cranial would be the first product in the Japanese market that combines OssDsign’s calcium phosphate composition and features internal titanium mesh reinforcement.