AngioDynamics, a medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced it received FDA 510(k) clearance for the NanoKnife System for prostate tissue ablation.
The clearance came following the completion of the pivotal PRESERVE clinical study and submission of results to the FDA in September. The study evaluated the safety and effectiveness of the system for ablating prostate tissue in patients with intermediate-risk prostate cancer (PCa). Conducted in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), PRESERVE enrolled 121 patients across 17 clinical sites.
The PRESERVE clinical study met its primary effectiveness endpoint demonstrating the performance of the NanoKnife System for the ablation of prostate tissue in patients with intermediate-risk PCa. At 12-months post-procedure, 84.0% of men were free from in-field, clinically significant disease. In addition, the study demonstrated strong quality of life outcomes with short-term urinary continence being preserved (96.6% at baseline, 95.4% at 12-months) and the ability to maintain erections sufficient for intercourse only decreasing 9% compared to baseline (80.7% to 71.7%).
The study’s results validated the robust safety and clinical efficacy profile of the NanoKnife System, reinforcing findings from more than 32 clinical studies performed around the world involving over 2,600 patients.
The company said the NanoKnife System is the first and only non-thermal, radiation-free, ablation technology designed to treat prostate tissue by using IRE technology, offering patients a minimally invasive option for prostate treatment.
The NanoKnife System delivers an innovative alternative to conventional radical surgery or radiotherapy, which often results in significant dysfunction in urinary continence and erectile potency. With its non-thermal approach, the system is engineered to preserve vital structures inside and outside the prostate.
