CairnSurgical selects Amnovis as exclusive supplier for its 3D-printed Breast Cancer Locator™ in Europe
Innovative surgical guide designed to reduce the incidence of positive margins after breast cancer surgery
Flam3D member Amnovis was selected by CairnSurgical for the Additive Manufacturing (AM) of the revolutionary Breast Cancer Locator™ (BCL) product for patients in Europe. The BCL is a patient-specific surgical guidance solution designed to assist surgeons in accurately locating and removing breast tumours. CairnSurgical relies on Amnovis, an innovator in contract manufacturing of AM products for medical applications. The Flam3D member has the necessary AM expertise and digital processes to successfully respond to stricter regulations and the need for greater speed and flexibility in medical production.
In 20 to 25 percent of Breast Conserving Surgeries (BCS or lumpectomy), clear tumour margins do not manage to be achieved, so these patients have to undergo a second operation. Such reoperations incur additional healthcare costs and are associated with poorer cosmetic results, a more difficult recovery and greater emotional strain for the patient. The BCL™ system is designed to improve the accuracy of breast-conserving surgery by providing accurate guidance on the shape, size and location of the tumour, allowing clear margins to be achieved.
The Breast Cancer Locator™ process follows a set of steps. As first step in the process, CairnSurgical receives the MRI data from the patient’s supine position, analyses it to determine the geometry and location of the tumour and uses this data to design the patient specific BCL™. For patients in Europe, Amnovis manufactures the BCL™ surgical guide using stereolithography 3D printing (SLA). The founders of Amnovis have a background in manufacturing high-end products using AM since 2008. Today, their skilled team works within a digital production framework that meets customer and regulatory requirements. As a result, Amnovis excels in flexible production and on-time delivery.
David Danielsen, CEO CairnSurgical, expressed his confidence in the Belgian company: “We chose Amnovis as our operating partner because we recognised that their expertise in 3D printing medical devices and their strong focus on quality systems was the right combination for us to enable the commercial launch of the BCL™ surgical guidance system in Europe. The entire Amnovis team impressed us with their strong knowledge base, their experience in quality management systems and printing, and their collaborative approach in developing a plan and operations that met our needs.”
Ruben Wauthle, CEO and co-founder of Amnovis: “We are extremely proud to be working with CairnSurgical on the BCL™. Innovative AM applications, such as this surgical guide, fit perfectly with our commitment to AM contract manufacturing as a company. We have established a comprehensive AM workflow and manufacturing platform that is fully ISO 13485:2016 certified. The digital process automation allows us to achieve paperless operations and provide full traceability and repeatability to flexibly scale up the production of patient-specific products.”