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AngioDynamics reports 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.
Pursuant to the recently enacted 21st Century Cures Act, the FDA has released draft guidance for a Breakthrough Devices Program, which, when finalized, will supersede the EAP. The FDA has indicated that all devices that receive EAP designation will gain Breakthrough Device designation when the guidance document becomes final.
Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc., commented, “The Expedited Access Pathway and Breakthrough Devices Program is an important and meaningful initiative to prioritize review and approval for novel, innovative devices needed by patients for the treatment of life-threatening diseases and conditions. We are thrilled that the FDA has granted the EAP designation to NanoKnife for the treatment of Stage III pancreatic cancer and are excited to continue working with the FDA toward approval of NanoKnife as a treatment for the underserved patient population suffering from this deadly disease.”