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CERAMENT® G RECEIVES FDA CLEARANCE FOR OPEN FRACTURES
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Mid Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
BONESUPPORT AB, a leading company in orthobiologics for the management of bone injuries, announces that the FDA has cleared the company’s 510(k) submission regarding the use of CERAMENT G in open fractures.
Open fractures are a consequence of trauma and carry a high risk of subsequent infection. The clearance more than doubles the US addressable market for CERAMENT G, which is the first and only combination product approved in the USA for this indication.
“Open fractures are one of the most common causes of a patient developing a bone infection, and we are very excited about this expanded indication. It means that American surgeons will have a new powerful tool to treat patients with skeletal injuries while simultaneously protecting the site from infection by local elution of antibiotics”, said Emil Billbäck, CEO of BONESUPPORT.
CERAMENT G is an orthopedic medical device combination matrix consisting of a resorbable synthetic bone graft substitute and the antibiotic gentamicin, which protects against colonization of bacteria sensitive to gentamicin.