Device Enables Surgeons to Pre-Set Precise Ablation Margins to Target Only Cancer Tissue

With close to 250,000 new cases diagnosed each year, prostate cancer is the most prevalent cancer among men after skin cancer and the second leading cause of cancer deaths among men. Prostate ablation is a procedure used to treat prostate cancer. During a prostate ablation procedure, energy (such as heat, cold, lasers, or chemicals) is used to kill the cancer cells. The energy may 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 through a distinctive “coil” electrode during a minimally invasive office-based procedure. The system allows the surgeon to pre-set precise ablation margins to target only the cancerous tissue, addressing the limitations of other forms of thermal ablation technologies for prostate cancer that risk damaging adjacent structures e.g., 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. Focal therapy of prostate cancer is a minimally invasive method to destroy more limited prostate cancers, in situ in the prostate, leaving the remainder of the prostate gland and surrounding important structures like the erectile nerves intact, reducing the risk of impaired urinary and sexual function as compared to other “whole-gland” directed therapies like surgery or radiation therapy. 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 primarily 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 cancer cell “kill” is indeterminate and difficult to precisely determine using thermocouples or imaging. Ablation therefore often extends beyond the area necessary to control the cancer in order to ensure complete cancer ablation. Important structures, often immediately adjacent to tumors, are therefore hard to preserve e.g. erectile nerves.

enCAGE Coil is a bipolar radio frequency-based probe (bRF) enabling precision ablation, limited only to the edge of the outer coil. Thus the ablation margin is pre-set via treatment planning and placement of the “coil” electrodes, yielding 100% ablation within the ablation zone in conjunction with 100% tissue preservation beginning just outside the ablation zone. This allows complete ablation of tumor tissue with preservation of adjacent erectile nerves. The device has FDA 510(k) approval and has been used in 51 patients, including 20 patients who participated in a Phase II trial. Imagin will be refining the device based on this experience for commercialization.