Admedus (ASX:AHZ) has announced it has received FDA 510(k) clearance to market VascuCel in the US.
“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,” said Admedus Chair and Interim CEO, Mr Wayne Paterson.
Admedus believes VascuCel will take significant market share in the US vascular market as it offers a premium next generation collagen scaffold for restorative vascular repair.
According to the company, 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 sterilized.
The company said, based on feedback from surgeons, it 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.
Admedus said it will launch VascuCel through the existing US sales team into the peripheral vascular market where there are an estimated 250,000 vascular repair procedures performed each year.