CERAMENT™|G registry now includes 230 cases conducted in 18 hospitals across 9 countries
Registry now updated to include CERAMENT™ V procedures
Lund, Sweden, (PRNEWSWIRE) February 2, 2016 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today provided an update on the Company’s CERAMENT™ procedure registry, established by BONESUPPORT™ in February 2014 as part of the proactive post-market surveillance process for the Company’s novel antibiotic eluting injectable bone substitutes. The CERAMENT™|G registry now includes 230 cases conducted in 18 hospitals across 9 countries. In addition, the registry has recently been updated to include CERAMENT™ V procedures.
The CERAMENT™|G registry includes a variety of complex procedures, including bone tumors, primary and revision hip and knee prostheses, osteomyelitis and infected diabetic foot. Moreover, the registry participants include a number of world-renowned surgeons, including Professor Carlo Romanò, Istituto Ortopedico Galeazzi, Milan Italy, Mr. Martin McNally, Nuffield Orthopaedic Centre in Oxford, United Kingdom and Professor Guido Wanner, University Hospital of Zurich, Switzerland. The CERAMENT™ registry provides the ability to add more hospitals, more indications and more product line extensions and is one of the most robust registries in the industry.
“This important registry offers hospitals the opportunity to share CERAMENT™ data with a view to analyzing inter-country or cross-country trends,” said Professor McNally. “I am pleased to be participating in, and contributing to this registry. We have shown that CERAMENT™|G is a safe and effective addition to the management of many complex indications, including chronic osteomyelitis, and look forward to generating further data to confirm this.”
“We are excited about the diverse set of procedures and compelling data being generated in our CERAMENT™ registry,” said Richard Davies, CEO of BONESUPPORT™. “This registry both ensures vigilance in the post-marketing surveillance for our products, and allows the data generated from these complex procedures to be collected and stored in a central location. We intend to work with our surgeon participants to ensure publication of this data in the future.”
Notes to Editor
BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT™|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.
CERAMENT™‘s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.
CERAMENT™|G and CERAMENT™ V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT™|G and CERAMENT™ V are available in the EU.
BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.
BONESUPPORT™ is a registered trademark.
Citigate Dewe Rogerson
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