AngioDynamics Gains FDA Nod for BPH Study Using NanoKnife IRE Platform

Event summary

  • FDA approved AngioDynamics' IDE application for the RELIEF feasibility study evaluating NanoKnife IRE for BPH treatment.
  • The study will enroll 40 subjects across up to five U.S. clinical sites.
  • Primary endpoints include mean change in IPSS score and incidence of device-related adverse events.
  • The study is led by co-Principal Investigator Felix Cheung, MD, from Memorial Sloan Kettering Cancer Center.

The big picture

AngioDynamics' FDA approval for the RELIEF study positions its NanoKnife IRE platform as a potential new treatment option for BPH, a condition affecting millions of men in the U.S. The study's focus on preserving sexual and urinary function aligns with the growing demand for minimally invasive procedures that balance effectiveness with quality of life. Success in this trial could expand AngioDynamics' footprint in the urology market beyond its established role in cancer treatment.

What we're watching

Clinical Efficacy
How the RELIEF study results will impact the adoption of IRE for BPH treatment.
Regulatory Pathway
Whether the feasibility study will pave the way for broader FDA approval of IRE for BPH.
Market Expansion
The pace at which AngioDynamics can commercialize the NanoKnife System for BPH if the study is successful.

Related topics

FDA Approval Medical Devices