Image: enCAGE Coil is a disposable focal therapy precision ablation device for prostate cancer (Photo courtesy of Pexels)
With nearly 250,000 new cases diagnosed each year, prostate cancer is the most common cancer in men after skin cancer and the second leading cause of cancer death in men. Prostate removal is a procedure used to treat prostate cancer. During a prostate removal procedure, energy (such as heat, cold, lasers, or chemicals) is used to kill cancer cells. The energy can also destroy some of the surrounding normal prostate tissue. Now, a new disposable focal therapy precision ablation device for prostate cancer delivers bipolar radiofrequency energy via a distinctive “wrapped” electrode in a minimally invasive, in-office procedure. The system allows the surgeon to pre-define precise ablation margins to target only cancerous tissue, addressing the limitations of other forms of thermal ablation technologies for prostate cancer which risk damaging adjacent structures, e.g. example the erectile nerves that control urinary and sexual function.
Imagin Medical (Auburndale, MA, USA) has acquired the enCAGE Coil precision ablation system for prostate cancer from TROD Medical NV, a Belgian company. Prostate cancer focal therapy is a minimally invasive method of destroying smaller prostate cancers, in situ within the prostate, leaving the rest of the prostate and surrounding important structures such as erectile nerves intact, thereby reducing the risk impaired urinary and sexual function. compared to other “whole gland” therapies, such as surgery or radiotherapy. Using mpMRI fused with real-time ultrasound to target the tumor improves the precision of the technique. Current focal ablation modalities for prostate cancer are mainly thermal therapies, either freezing (cryotherapy) or heating (HIFU, single electrode RF, laser, water, steam, electricity). All suffer from the same challenges as the lesion grows from the center outward. The margin of “death” of cancer cells is indeterminate and difficult to determine accurately using thermocouples or imaging. The ablation therefore often extends beyond the area needed to control the cancer to ensure complete removal of the cancer. Important structures, often immediately adjacent to tumors, are therefore difficult to preserve, for example erectile nerves.
enCAGE Coil is a bipolar radio frequency (bRF) probe allowing precision ablation, limited only to the edge of the outer coil. Thus, the ablation margin is pre-set via treatment planning and “wrapped” electrode placement, producing 100% ablation in the ablation zone in conjunction with 100% tissue preservation beginning just at the outside the ablation zone. This allows complete removal of tumor tissue with preservation of adjacent erectile nerves. The device is FDA 510(k) cleared and has been used in 51 patients, including 20 patients who participated in a phase II trial. Imagin will refine the device based on this experience for commercialization.