LAVAL, QC, CANADA--(Marketwire -01/23/12)- Biomomentum Inc., a company specializing in testing solutions for biomaterials and articular cartilage, is pleased to announce that it has received CE marking for the Arthro-BST™, an arthroscopic probe developed for precise and non-destructive evaluation of articular cartilage. Review of the technical file by AMTAC Certification Services Limited (Intertek) demonstrated that Biomomentum's production quality assurance system conforms to the provisions of the UK national legislation, transposing Annex V of the Directive 93/42/EEC on medical devices.
This marking complements the Arthro-BST™'s medical device license received from Health Canada (license #86664) following an ISO 13485:2003 audit of the company's Quality Management System by Intertek, a CMDCAS recognized registrar.
"These were major milestones for the Arthro-BST™ and we are very proud of the accomplishments. This device is well under way to revolutionizing arthroscopic assessments of cartilage by providing the surgeon with reliable and quantitative cartilage evaluations. Biomomentum will now mobilize its resources and work with the best orthopaedic surgeons to break the paradigms and promote this game-changing product", said Dr. Eric Quenneville, co-founder and CEO.
Biomomentum specializes in providing solutions for the biomechanical evaluation of biomaterials and cartilage. The Arthro-BST™ is a hand-held medical device used in conjunction with arthroscopic procedures for the non-destructive measurement of compression-induced streaming potentials of articular cartilage. The instrument measures streaming potentials generated during gentle compression of the articular cartilage and calculates a quantitative parameter reflecting its electromechanical properties. Scientific literature has indicated that streaming potentials are not only a function of the stiffness of cartilage, but also of its composition, structure, and thickness. In addition to its clinical applications, the Arthro-BST™ offers a vast array of research opportunities in the field of cartilage repair. Biomomentum also commercializes the Mach-1™, a modular, multiple-axis mechanical tester capable of performing compression, tension, shear, and torsion tests for the precise characterization and mechanical stimulation of cartilage and other soft tissue or materials. For more information about Biomomentum, its products and GLP-compliant biomechanical testing services, visit www.biomomentum.com.
La version francaise de ce communique est disponible au www.biomomentum.com/fr.