The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to Cohera Medical to initiate the first no-drain clinical trial of its internal surgical adhesive.

The CE-marked TissuGlu surgical adhesive is designed for use during abdominoplasty surgeries to help reduce fluid accumulation and the need for post surgical drains.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The chemical composition of TissuGlu, which is resorbable and non-toxic, forms a strong bond between underlying tissue layers to reduce the space where fluids can accumulate, and allows for natural healing.

“The CE-marked TissuGlu surgical adhesive is designed for use during abdominoplasty surgeries to help reduce fluid accumulation and the need for post surgical drains.”

The controlled, multicentre, non-inferiority and prospective study will enrol 130 patients undergoing abdominoplasty to compare the standard wound closure technique with drains (control) to the standard wound closure technique including TissuGlu and no drains (test).

The study, which is expected to begin in early 2013, will randomise patients into either a treatment group with the application of TissuGlu or a control group without the use of TissuGlu.

The Hunstad-Kortesis Centre spokesperson Dr Joseph Hunstad said mostly patients complain about the drain management and discomfort caused during abdominoplasty surgeries.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“We are excited to begin enrolling patients and we believe that completely eliminating the use of drains would significantly improve patient care and satisfaction,” Hunstad said.

Cohera Medical president and CEO Patrick Daly said; “We believe that the elimination of post-surgical drains has the potential to positively impact surgeries and the recovery of millions of patients worldwide.”