BioZorb consists of a spiral coil in a 3D shape and attached to the coil are 6 titanium clips (see image above right). The devices come in different sizes to accommodate a range of lumpectomy sizes and the spiral coil is bioresorbable, meaning the material is absorbed by the body over a period of 12 months. The small titanium markers remain permanently in the breast and their 3D pattern can be visualized using standard imaging techniques. Focal received FDA approval for their device in 2012 and the first clinical results were recently presented at the 2015 Breast Cancer Symposium in San Francisco.
Dr Steven Harms, the radiologist who presented the study which included more than 100 patients, commented “After surgery to remove a breast cancer tumour, scar tissue can make it difficult for us to see if the cancer has returned.” This is because scar tissue can hide things or even look just like cancer. Harms went on to say, “I was pleasantly surprised when I viewed the mammograms after surgery since the device appears to provide a mechanism to assist the growth of healthy tissue. This is very exciting since the marker has made it easier for us to monitor these patients.”
Harms (seen left) also established that the tissue marker was readily imaged with a variety of diagnostic modalities – including mammography, ultrasound, computer tomography, magnetic resonance imaging and digital breast tomosynthesis – traditionally employed by radiologists to monitor breast cancer patients. Prior research has shown that the device improves cosmetic results after lumpectomy and also helps with planning radiotherapy treatment by minimizing the exposure of healthy tissue to unnecessary radiation.
Dr Christopher Glaser believes the device could represent a “quantum leap” in the ability to demarcate breast tissues for post-surgical radiation planning. This is high praise indeed for a medical device that is deceptively simple. Perhaps that’s just the point, though, where the most successful designs are both elegant and simple.