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FDA Clears CardioVia’s ViaOne Device for Safer Heart Access – Medwire

FDA Clears CardioVia’s ViaOne Device for Safer Heart Access

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CardioVia has received FDA clearance for its ViaOne technology, which enables clinicians to access the surface of the heart without using an exposed needle. The device works by pulling the pericardium away from the heart, allowing a concealed, blunt-tip needle to access the pericardial space, reducing the risk of perforation and other complications.

Key Features:

  • Minimized Risk: The ViaOne device significantly lowers the chance of complications during cardiac interventions, making it safer for both patients and clinicians.
  • Position Tracking: Sensors within the device ensure accurate positioning, streamlining the procedure.
  • Broad Impact: Designed for use by interventional cardiologists and electrophysiologists, the platform enhances procedural safety and efficacy.

CEO Ziv Menshes described ViaOne as a groundbreaking platform that will transform heart-surface therapies. Dr. David Luria, director of electrophysiology at Hadassah Medical Center, emphasized its potential to improve procedural efficiency and reduce complications in cardiac care.

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