AngioDynamics recently declared the achievement of FDA 510(k) clearance for its NanoKnife System, intended for prostate tissue ablation in individuals with moderate-risk prostate cancer.
The approval is a result of the concluding phase of the pivotal PRESERVE clinical trial, which engaged 121 participants across 17 locations and was conducted in partnership with the Society of Urologic Oncology Clinical Trials Consortium.
The trial illustrated the system’s safety and efficacy, showing that 84% of patients remained free from clinically significant in-field disease a year following the procedure. Additionally, it highlighted promising quality-of-life benefits, such as the maintenance of urinary continence and minor impact on erectile function soon after the treatment.
In a press statement, AngioDynamics President and CEO Jim Clemmer expressed, “Gaining FDA approval for the NanoKnife System in prostate tissue management is a remarkable achievement for us. This progress marks an essential milestone towards establishing our solution as a standard, function-conserving treatment for prostate cancer. The NanoKnife System significantly reduces the severe complications typically linked to conventional therapies by selectively targeting prostate tissue while preserving crucial functions.”
About the NanoKnife System
The NanoKnife System utilizes a non-thermal and radiation-free irreversible electroporation (IRE) technique to accurately ablate prostate tissue, presenting both clinicians and patients with a minimally invasive substitute to traditional surgery or radiotherapy.
AngioDynamics emphasizes that NanoKnife’s method seeks to enhance recovery periods and maintain urinary and sexual functionality, addressing prevalent apprehensions tied to prostate cancer treatments.
Prostate cancer ranks as the second most prevalent cancer among men worldwide, with 1.5 million new diagnoses each year, compelling many to seek alternatives to aggressive treatments with long-lasting adverse effects.
To facilitate physician integration of the NanoKnife System, AngioDynamics will bolster its efforts through extensive training, education, and proactive outreach initiatives intended to enlighten patients about their treatment choices.
“These initiatives aim to expedite the adoption of NanoKnife technology, reshape prostate healthcare standards, and furnish the treatment results that patients and doctors demand. Dedicated to leveraging this groundbreaking technology for significant impact, AngioDynamics offers renewed hope to patients and boosts quality of life,” Clemmer concluded.