AngioDynamics’ NanoKnife System Secures the US FDA’s 510(k) Clearance for Prostate Tissue Ablation
Shots:
- The US FDA’s approval of the NanoKnife System for prostate tissue ablation was based on pivotal PRESERVE trial assessing its safety & efficacy in patients (n=121) with intermediate-risk prostate cancer
- Study achieved its 1EP, showing 84% of men free from in-field disease at 12mos.; urinary continence was largely preserved (96.6% to 95.4%) & erectile function decreased by 9% (80.7% to 71.7%). Results confirm the system's safety & efficacy, supported by over 32 global studies involving 2,600+ patients
- The device creates nanopores in the cell membrane by using Irreversible Electroporation (IRE) technology, inducing apoptotic-like death and complete tissue ablation
Ref: AngioDynamics | Image: AngioDynamics
Related News:- AngioDynamics Commences the RECOVER-AV Study of AlphaVac F1885 System to Treat Pulmonary Embolism
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
