AngioDynamics’ NanoKnife System receives IDE approval for clinical study from US FDA

18 June 2013 (Last Updated June 18th, 2013 18:30)

US-based medical devices manufacturer AngioDynamics has secured Investigational Device Exemption (IDE) clearance from the US Food and Drug Administration to carry out a clinical study of the NanoKnife System for the focal ablation of prostate cancer.

US-based medical devices manufacturer AngioDynamics has secured Investigational Device Exemption (IDE) clearance from the US Food and Drug Administration to carry out a clinical study of the NanoKnife System for the focal ablation of prostate cancer.

AngioDynamics is now proceeding with submissions for institutional review board (IRB) approval and expects to begin enrolling patients in the second quarter of fiscal 2014 that ends on 30 November 2013.

Following the IRB approval, the University of Miami will also take part in the clinical study.

AngioDynamics oncology / surgery business senior vice president Rick Stark noted that the time is appropriate to expand the NanoKnife System's evidence base in prostate.

"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 high-quality insight into the potential for this technology," added Stark.

"AngioDynamics is now proceeding with submissions for institutional review board (IRB) approval and expects to begin enrolling patients in the second quarter of fiscal 2014 that ends on 30 November 2013."

Meanwhile, AngioDynamics has separately entered into a tie-up with the Clinical Research Office of the Endourological Society (CROES) to conduct a study, titled 'Multicenter randomized two-arm intervention study evaluating irreversible electroporation for the ablation of localized unilateral prostate cancer'.

The study, which will enroll 200 patients at six centres in Europe, is intended to establish the NanoKnife System's position within the treatment armamentarium for low-intermediate localised prostate cancer.

AngioDynamics president and CEO Joseph M DeVivo noted that the company has made a long-term investment in the opportunity the NanoKnife System offers to physicians and their patients.

"The place for this therapy is opening up as we pursue high quality evidence, and we look forward to sharing further details during our fourth quarter fiscal year 2013 earnings report and conference call," added DeVivo.

AngioDynamics manufactures minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology.