AngioDynamics Earns IDE for Prostate Cancer Ablation Device

Albany, N.Y.-based AngioDynamics has gained an investigational device exemption (IDE) from the U.S Food and Drug Administration (FDA) to conduct a clinical study of the Nanoknife system for the ablation of focal prostate cancer.

The company is moving forward with institutional review board (IRB) submissions and expects to begin enrolling study participants during the company’s fiscal 2014 second quarter, which ends Nov. 30, 2013.

“The time is right to expand the Nanoknife system’s evidence base in prostate,” said Rick Stark, senior vice president of AngioDynamics’ oncology/surgery business. “Patients want less invasive procedures, and as imaging technology improves, the urology field is echoing the call by demanding options for focal ablation. With institutions like the University of Miami agreeing to participate in a study upon IRB approval, we are positioned to achieve insight into the potential for this technology.”

Separately, AngioDynamics has established a partnership with the Clinical Research Office of the Endourological Society (CROES) and is pursuing a study to establish evidence for the Nanoknife system’s position within the treatment armamentarium for low-intermediate localized prostate cancer. The study, “Multicenter Randomized Two-Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Unilateral Prostate Cancer,” will involve six European centers and 200 patients.

“AngioDynamics has made a long-term investment in the opportunity the Nanoknife system offers to physicians and their patients,” said Joseph M. DeVivo, AngioDynamics president and CEO. “The place for this therapy is opening up as we pursue evidence, and we look forward to sharing further details during our fourth quarter fiscal year 2013 earnings report and conference call.”

Angiodynamics makes minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology.