Hologic won FDA clearance and is releasing its Affirm prone biopsy guidance system, a product already approved in Europe. The system provides both 2D and 3D image guidance for performing breast biopsies. The system has a relatively wide field of view to more easily access suspect lesions found during 3D mammography exams.
The system includes an integrated C-arm fluoroscope and the biopsy needle delivered from different angles without having to reposition the patient. Hologic believes the new system will cut down procedure times compared to its current MultiCare Platinum system. Moreover, patients no longer see the needle at all, helping to reduce unneeded anxiety.
“Until now, we’ve been struggling to handle complex biopsies for subtle lesions or faint calcifications that we are only able to identify using 3D MAMMOGRAPHY™ exams,” said Dr. Alejandro Tejerina of the Centro Patologia de la Mama, Fundación Tejerina in Madrid, Spain, in a statement. “As an early testing site for the Affirm™ prone biopsy system, we’ve had the opportunity to perform many biopsies using this technology, and are pleased to report that this new biopsy table has helped to solve our challenges. We are able to visualize more tissue and have access to challenging lesion locations, and the procedures are very fast.”