AngioDynamics, Inc. Receives FDA Expedited Access Pathway Designation for the Nanoknife System for the Treatment of Stage III Pancreatic Cancer
January 24, 2018 at 04:37 pm EST
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AngioDynamics, Inc. announced that the United States Food and Drug Administration (FDA) has granted the Expedited Access Pathway (EAP) designation to the Company's NanoKnife System and proposed indication for use for the treatment of Stage III pancreatic cancer. The EAP program is designed to help patients gain more timely access to medical devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, for which no approved or cleared alternatives exist. This is achieved by expediting the device's assessment and review processes through more interactive and timely communication with the FDA, pre- and post-market balance of data collection requirements, efficient and flexible clinical study design, FDA review team support and Agency senior management engagement, and priority review.
AngioDynamics, Inc. is a transformative medical technology company. The Company is focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving quality of life for patients. It designs, manufactures, and sells a range of medical, surgical and diagnostic devices used by professional healthcare providers for vascular access, for the treatment of peripheral vascular disease and for use in oncology and surgical settings. Its devices are generally used in minimally invasive, image-guided procedures. Its segments include Med Tech and Med Device. Its product categories include oncology, venous therapies, vascular interventions, and ports. Its oncology products include Model 1500X RF Generator, IsoLoc Endorectal Balloon, Habib 4X Laparoscopic Bipolar Resection Device, Habib 4X Bipolar Resection Device, and Alatus. Its venous therapies include VenaCure EVLT 1470 Pro Laser, VenaCure EVLT System, VenaCure EVLT Procedure Packs, and others.