AngioDynamics has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) application of its NanoKnife System in the treatment of stage III pancreatic cancer.
The NanoKnife System is designed for surgical ablation of soft tissue. It uses low-energy electrical pulses to permanently open pores in target cell membranes, which leads to cell death.
In 2008, the FDA granted 510(k) clearance for the device. The latest lDE approval will enable AngioDynamics to initiate its DIRECT clinical study, which will evaluate the NanoKnife System in around 250 patients with stage III pancreatic cancer.
The study will involve a series of randomised controlled trials (RCT) in up to 15 clinical sites and real-world evidence, next-generation registry (RWE) at up to 30 centres.
The primary endpoint of the study is overall survival (OS). The trial will work with a comprehensive data collection strategy to capture meaningful clinical information and support a regulatory indication for pancreatic cancer.
AngioDynamics president and CEO Jim Clemmer said: “We are confident that our comprehensive approach, crafted through a constructive dialogue with the FDA, will generate meaningful data for clinicians, patients, payors and other stakeholders who are equally committed to fighting this disease, and we are dedicated to the idea that the standard of care for this deadly disease can and should improve.”
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The company is launching AngioDIRECT.com to enable patient enrolment into the DIRECT study. This platform will consist of information about pancreatic cancer and the study.
A physician locator will also be available on the platform to facilitate identification of study locations.
In the US, pancreatic cancer is diagnosed in around 57,000 people each year and leads to approximately 46,000 deaths.