The Food and Drug Administration (FDA) has cleared Cerament G for use as a bone void filler in skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement as part of the surgical treatment of osteomyelitis.
Cerament G is a resorbable, gentamicin-eluting ceramic bone graft substitute consisting of hydroxyapatite, α-calcium sulfate hemihydrate, and the aminoglycoside antibiotic gentamicin sulfate. The combination allows for natural bone healing, while reducing the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms. Cerament G resorbs and is replaced by bone during the healing process; the cured paste acts as a temporary support media. Lincomycin Spectinomycin Injection
“The benefits of Cerament G for patients and clinics, have been validated in several very strong clinical trials, and have paved the way for our strong sales in Europe, where Cerament G accounts for a clear majority of our sales,” said Emil Billbäck, CEO of BONESUPPORT.
The FDA has classified Cerament G a Class II device under the generic name resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial. It is intended for reduction of recurrence of chronic osteomyelitis of long bone, but not to treat infection.
The use of Cerament G is contraindicated in patients with myasthenia gravis, severe renal impairment, pre-existing calcium metabolism disorder, and in patients who are pregnant or breastfeeding.
Latest News Your top articles for Wednesday
Haymarket Medical Network Top Picks
Continuing Medical Education (CME/CE) Courses
Please login or register first to view this content.
Enrofloxacin For Birds Copyright © 2023 Haymarket Media, Inc. All Rights Reserved. This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Your use of this website constitutes acceptance of Haymarket Media’s Privacy Policy and Terms & Conditions.