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Avvio Medical’s Avvio Enhanced Lithotripsy System (ELS) Receives the US FDA’s Breakthrough Device Designation (BDD) for Kidney Stone Treatment

Shots:

  • The US FDA has granted BDD to Avvio ELS for minimally invasive, anesthesia-independent kidney stone treatment
  • AVVIO ELS will be investigated in a pivotal ELS trial across the US following IDE approval, with US commercial launch planned in 2026, pending FDA clearance
  • The AVVIO ELS uses microbubble-enhanced acoustic cavitation lithotripsy to enable minimally invasive kidney stone treatment in ambulatory surgery centers & cystoscopy suites, eliminating the need for general anesthesia, fluoroscopy, or costly equipment

Ref: Businesswire | Image: Avvio MedicalPress Release

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