BrosMed Announced CE MDR Approval of Pregarde™ Guiding Sheath
Release time:
2025-09-09
September 9, 2025- BrosMed announced that its Pregarde™ Guiding Sheath has been certified under the European Union Medical Device Regulation (MDR), further strengthening its peripheral intervention portfolio.
Pregarde™ Guiding Sheath supports all applicable diagnostic and interventional procedures, offering sizes from 4 F to 8 F, four lengths, six tip shapes, and two valve options.
- Versatile sizing: 4 F–8 F and four suitable lengths（45，65，90，110cm）
- Six tip shapes: Straight, multi-purpose, crossover and more, to match any access scenario.
- Two valve options: Cross-cut or Y-shape hemostasis valves to reduce the risk of bleeding.
Pregarde™ combines the benefits of an introducer sheath and a guiding catheter with:
- Atraumatic tapered tip + hydrophilic coating: Reduces puncture resistance and vessel trauma for smoother insertion and navigation.
- Triple-layer construction: Outer soft-to-hard Pebax, mid-layer reinforced steel coil and inner PTFE liner for superior support and kink resistance.
- Distal Pt-Ir marker: Ensures excellent radiopacity for precise positioning under X-ray.
With its versatile sizing, hydrophilic tapered tip and reinforced triple-layer support, the Pregarde™ Guiding Sheath delivers reliable performance for safe, efficient peripheral interventions.
For more information about Pregarde™ Guiding Sheath from BrosMed, please visit the BrosMed website or contact us via e-mail: Sales@brosmed.com.
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