Now that it has received FDA clearance, hospitals in the U.S. can purchase Hologic’s Affirm prone biopsy system for breast cancer detection, the first 2-D/3-D imaging-guided prone biopsy system to enter the U.S. market.

The system — which received CE mark for commercial usage in the EU last month — gives radiologists 360 degree access to the breast with minimal movement to the patient lying on the memory foam platform, allowing the radiologist to better target a lesion.

The system offers increased automation, significantly improved software with fewer steps than traditional stereotactic biopsies, and supports the patient stably while providing isolation from the biopsy needle, Ben Boese, product director of biopsy navigation at Hologic, told HCB News.

Compared to prone biopsy systems on the market today, the Affirm system has a larger field of view at 14.3 cm x 11.7 cm, and a high-resolution amorphous selenium detector, which captures and converts the X-ray energy directly into digital signals.

In January, Hologic had partnered with two facilities to perform the first patient biopsies using the Affirm system. “At those sites, we are assessing many parameters such as procedure speed and image quality. While the work is ongoing, the results for the first 30+ patients have been very positive,” Boese said.

At the Centro Patología de la Mama, Fundación Tejerina in Madrid, Spain, Dr. Alejandro Tejerina said that his team had been struggling to handle complex biopsies for subtle lesions or faint calcifications, but had the opportunity to perform biopsies using the Affirm system along with the company’s 3-D mammography exam.

“We 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,” he said, in a statement.

In addition to the installation in Spain, the Affirm system is also being utilized in Spaarne Gasthuis, Netherlands and Fondazione IRCCS Istituto Nazionale dei Tumori in Milan.

For facilities purchasing the system in the U.S., Hologic said shipping and delivery will be coordinated based on the facility’s preparedness for installation.

Earlier this month, a review conducted by the York Health Economics Consortium, a consultancy and research company, confirmed the benefits of using Hologic’s 3-D mammography exam, which consists of breast tomosynthesis and digital mammography.

Doctors were able to screen for breast cancer with 41 percent more accuracy than just a 2-D exam, regardless of age or breast density, and patients had a 40 less chance of being called back for additional screening.

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