US-based healthcare firm Zimmer Biomet Holdings is set to launch its Subchondroplasty (SCP) Procedure across multiple countries, for the treatment of bone marrow lesions (BMLs).
The firm has secured CE mark approval for the procedure, enabling distribution in the European Union (EU) and other countries that recognise the CE mark, along with approval for distribution in Canada, Singapore, Malaysia and Hong Kong.
The SCP Procedure is a minimally invasive outpatient intervention designed to repair the defects caused due to subchondral (BMLs), by filling them with a porous injectable calcium phosphate (CaP) called AccuFill Bone Substitute Material.
The healthy bone then replaces the bone substitute, which is slowly resorbed.
The new procedure is performed with arthroscopy to enable visualisation and to treat findings inside the joint, while the defect might sometimes require an open or mini-open procedure to facilitate access.
Zimmer Biomet Group president David Nolan said: "The international release of the Subchondroplasty Procedure is a major milestone for our company and for patients with chronic bone marrow lesions.
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"The procedure offers a tool that fills a gap in the patient treatment algorithm for the surgeon.
"We are eager to begin our international commercial launch."
Diagnosed with an MRI and physical exam, BMLs may develop due to stress fractures or micro-fractures of the bone adjacent to the joint, resulting in cartilage degeneration, limited function, pain and joint deterioration. .
With 36 patents and eight trademarks, the SCP procedure can be used for bone defects of the knee, foot, ankle and hip.