Advanced Medical Solutions, a specialist in tissue-healing technologies, has received FDA 510(k) approval for LiquiBand XL, a new device that can close longer wounds than existing LiquiBand products.
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Rubber stamping that says 'FDA Approved'.
The device consists of a surgical mesh which is used to close the wound and LiquiBand glue which is used to strengthen the closure and prevent infection. Product launch into the US is expected in the third quarter of 2022.
The device has been used successfully on a variety of orthopaedic procedures in multiple territories since its European approval in 2021 and has received very positive feedback in terms ease of use, efficacy and reduced pain and scarring in comparison with other closure methods such as stapling.
The addition of LiquiBand XL to AMS’ Advanced Wound Closure portfolio is an important step in the development of this franchise. It provides access to a new $60 million, long wound sealant market in the US but also increases the overall strength of the LiquiBand portfolio, as it completes the range of applications available, significantly improving the company’s ability to win new contracts and bundle products.
Chris Meredith, chief executive officer of AMS, said: “I am delighted to announce the FDA approval of LiquiBand XL in the US and the addition of this product to our highly successful US LiquiBand franchise. There is strong demand for the product from hospitals and our distribution partners and we are confident that it will make a significant impact in the market and will play a critical role in strengthening the market share of the entire LiquiBand franchise.”
