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First Synthetic Adhesive For Internal Use Gets FDA Approval

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Fuelled by technological advancements and innovations, the demand for improved medical adhesives and sealants for surgical procedures has been on the rise. The global medical adhesives and sealants market was valued at $6.39 billion in 2013 and is expected to reach $11.75 billion by 2020, according to a market report published by Transparency Market Research.

Although there are number of topical tissue adhesives, there hasn't been one for internal use. But that is going to change now - with the FDA approving TissuGlu, a synthetic adhesive developed by privately-held Cohera Medical Inc.

TissuGlu is a urethane-based adhesive that a surgeon can use to connect tissue flaps made during surgery to remove excess fat and skin or to restore weakened or separated abdominal muscles (abdominoplasty surgery, also known as tummy tuck).

And this is how TissuGlu works...

Drops of liquid TissuGlu are applied by a surgeon using a hand-held applicator. After applying the drops, the surgeon positions the abdominoplasty flap in place. Water in the patient's tissue starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures.

Being resorbable and biocompatible, TissuGlu breaks down and is eliminated naturally by the body after the patient is healed, according to the company.

Following abdominoplasty surgery, most patients require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. Since TissuGlu Surgical Adhesive helps to reduce fluid build-up by holding tissues close together and also prevents empty spaces from forming, the need for uncomfortable and inconvenient post-surgery drains can be eliminated.

In a clinical study of 130 participants undergoing elective abdominoplasty, half of the participants received surgical drains while the other half received TissuGlu and no drains. In abdominoplasty procedures, drains are used to control fluid output and seroma formation.

According to the study results, 73 per cent of participants who received TissuGlu required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps.

TissuGlu Surgical Adhesive received European CE Mark in 2011. In Europe, TissuGlu is currently being utilized to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty, mastectomy, lymph node dissection, decubitus and latissimus dorsi flap procedures. Till date, over 2,000 procedures have been conducted with TissuGlu, according to Cohera Medical.

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