The FDA approved AngioDynamics’ investigational device exemption (IDE) application for its NanoKnife Irreversible Electroporation “Direct IRECancer Treatment” clinical study (DIRECT). The DIRECT Study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer.
The DIRECT study is a randomized controlled study at up to 15 sites and a real-world evidence, next-generation registry (RWE) at up to 30 sites, each with a NanoKnife System treatment arm and a control arm. AngioDynamics expects each NanoKnife arm to consist of approximately 250 patients with an equal number of control patients. The primary endpoint of the study is overall survival.
The RCT component of the DIRECT study is intended to demonstrate the efficacy of the NanoKnife System by isolating variables in a controlled setting. As results from a hyper-controlled setting do not always translate to clinical practice, the study also includes a RWE component to provide clinicians, patients, and payors with data generated in a real-world setting.
As part of the DIRECT clinical study, AngioDynamics is launching AngioDIRECT.com to facilitate the enrollment of patients.
About Pancreatic Cancer
Pancreatic cancer is a disease in which malignant (cancerous) cells form in the tissues of the pancreas. The pancreas is a gland located behind the stomach and in front of the spine. There are approximately 57,000 new cases and 46,000 estimated deaths from pancreatic cancer in the United States annually. Approximately 35 to 40 percent of patients will present with Stage III and 45 to 55 percent with metastatic disease. For all stages combined, the five-year relative survival rate is 8 percent and, for those with advanced disease at the time of diagnosis, the five-year survival rate remains at 3 percent. There are limited treatment options for Stage III and IV disease, with chemotherapy and/or radiotherapy considered the standard of care.
About NanoKnife System
The NanoKnife Ablation System utilizes low energy direct current electrical pulses to permanently open pores in target cell membranes. These permanent pores, or nano-scale defects, in the cell membranes result in cell death. The treated tissue is then removed by the body’s natural processes in a matter of weeks, mimicking natural cell death. Unlike other ablation technologies, the NanoKnife Ablation System does not achieve tissue ablation using thermal energy.
The NanoKnife System has received 510(k) clearance from the Food and Drug Administration for the surgical ablation of soft tissue. The FDA granted the NanoKnife System a Breakthrough Device Designation in January of 2018 under the 21st Century Cures Act.Source: Apnews