CairnSurgical will create a 3D printed breast cancer locator in Europe

Patient-specific 3D printing technology designed to improve the accuracy of breast cancer surgery (specifically, lumpectomies) will soon be available in Europe.

Lebanon, based in NH CairnSurgical selected Amnovis based in Aarschot, Belgium to 3D print the Breast Cancer Locator (BCL) for patients in Europe. The device is a patient-specific surgical guidance solution designed to help breast surgeons accurately locate breast tumors. Amnovis is a contract manufacturer of additive manufacturing for medical applications.

The Breast Cancer Localization System is designed to guide the surgeon regarding the shape, size and location of the tumor to achieve clear margins during lumpectomies.

As the first step in the process, CairnSurgical receives MRI data from the patient in the supine position, analyzes it to define the geometry and location of the tumor, and uses the data to design the patient-specific breast cancer locator. For patients in Europe, Amnovis manufactures the Breast Cancer Locator surgical guides using stereolithography 3D printing.

Image courtesy of CairnSurgical

“We chose Amnovis as our operational partner because we recognized that their expertise in 3D printing of medical devices and their strong focus on quality systems was the right combination to enable us to commercially launch the BCL Surgical Guidance System in Europe,” said the CEO of CairnSurgical. David Danielson. “The entire Amnovis team has impressed us with their knowledge base, experience with quality and print management systems, and their collaborative approach to developing a plan and operations that meet our needs. “

The Breast Cancer Locator is considered an investigational device in the United States and is restricted by United States law to investigational use only. The BCL is a custom device under EU MDR regulations and is available for commercial use in the European Union.

“We are extremely proud to partner with CairnSurgical on BCL,” said Ruben Wauthle, CEO and Co-Founder of Amnovis. “Innovative AM (additive manufacturing) applications, like this surgical guide, are a perfect fit with our drive to innovate in AM contract manufacturing as a company. AM work and production, fully ISO 13485:2016 certified Digital process automation enables us to achieve paperless operations and provide full traceability and repeatability to flexibly augment manufacturing of specific products to patients.”

Comments are closed.