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SIMVALVE FLEX

SIMVALVE FORCE
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Simvalve FLEX is a low‑profile PTV (Percutaneous Transluminal Valvuloplasty) balloon catheter developed by Simeks Medical, designed specifically for use in  tructural heart procedures such as aortic and pulmonary valvuloplasty and pre‑dilatation in transcatheter heart valve interventions

Key Features & Technical Specs:

  • Lowest sheath size compatibility among Simvalve products: optimized for use with the smallest introducer sheaths available

  • Advanced balloon folding, allowing ultra-low profile re-wrap and smoother removal after dilation.

  • Rapid inflation/deflation technology and a coaxial shaft engineered for excellent trackability and pushability.

  • Flexible, atraumatic distal tip, enhancing safety during navigation

  • Diameter range: 12 mm to 30 mm, including sizes not always offered in high-pressure variants.

  • Balloon material: Nylon 12; shaft length: ~100 cm for all sizes; balloon folds vary by size (2–3 folds), tightening overall profile
  • Nominal pressure: 3 atm (22–30 mm), 4 atm (14–18 mm), 5 atm (12 mm); burst pressure: 5 atm (12 mm), 4 atm (14 mm), or 3 atm for the largest diameters
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🩺 Clinical Use & Performance

  • Expanding use in pre‑TAVR workflows for anatomically constrained or small-caliber patients.

  • Increasing adoption in pediatric or congenital valve interventions, where small sheath size and gentle dilation are essential.

  • Likely inclusion in clinical registries or device trials to validate performance compared to other flexible balloon catheters such as Tyshak II or Mammoth catheters; comparative data in high-pressure contexts remains limited

  • Innovative procedural strategies may evolve where FLEX is paired with high‑pressure balloons like FORCE: FLEX used initially to traverse delicate anatomy, followed by FORCE for final high‑pressure dilation if needed.

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