US FDA clears Admedus Vascucel

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Admedus Limited has received US Food and Drug Administration (FDA) 510(k) clearance to market VascuCel.

“The FDA clearance for VascuCel is important for Admedus as we build on the existing Adapt product portfolio. It adds to the new company strategy of focusing on products that are near to market, refining the product range and driving sales growth” says Admedus chair and interim chief executive officer Wayne Paterson.

According to a company release, VascuCel provides:

  • “improved handling in that it is supple yet strong, and remains pliable and conformable;
  • enhanced procedural efficiency as it is readily available off-the-shelf with no rinse required;
  • ease of suturing while remaining resistant to suture line bleeding resulting in excellent haemostasis;
  • improved biocompatibility with zero aldehyde toxicity;
  • optimised healing and clinical performance with no stimulus for thrombosis, inflammation, or foreign body reaction, enabling rapid endothelialisation and new native tissue growth; and
  • reduced risk of infection as it is terminally sterilised.”

Based on feedback from surgeons, Admedus will initially launch two sizes of VascuCel, a 2cm x 8cm and a 0.8cm x 8cm, with the latter specifically designed for carotid endarterectomy procedures. The Admedus manufacturing team has finalised several process improvement projects and ample product inventory has been manufactured to support this launch.

According to the release, Admedus will launch VascuCel through the existing US sales team into the peripheral vascular market.