Shots:
- Cardiawave has received the European CE Mark for its Valvosoft to treat Severe Symptomatic Aortic Stenosis (sSAS)
- Valvosoft delivers precise high-intensity ultrasound that induces non-thermal, mechanical energy to soften aortic valve leaflets tissues, restoring their mobility & improving anatomical & hemodynamic function
- Valvosoft was evaluated in the Valvosoft FIM Study (24mos.) & Pivotal Study (12mos.) in 100 highly comorbid elderly pts across 4 EU countries, showing feasibility, safety, & clinical benefits, with durable improvements observed after 1yr. of treatment, incl. improved cardiac function & QoL
Ref: Cardiawave | Image: Cardiawave | Press Release
Related News: Abbott’s Navitor TAVI System Receives European CE Mark for Aortic Stenosis in Patients at Low or Intermediate-Risk for Surgery
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