Physician Resources
New Products/Product News
Am J Orthop. 2009 April;38(4):205-206
Single-Injection Viscosupplementation
| Genzyme Corporation announced on February 26, 2009, that the US Food and Drug Administration has granted marketing approval for Synvisc-One™ (hylan G-F 20), a product intended for the relief of pain associated with osteoarthritis of the knee. Synvisc-One is the only single-injection viscosupplement approved for the treatment of OA knee pain in the United States. Synvisc-One is administered through a single intra-articular injection. It is an alternative treatment regimen to Genzyme’s Synvisc® (hylan G-F 20), a 3-injection viscosupplement approved in the United States in 1997 and in use worldwide for more than 16 years. Synvisc-One contains the same material and total treatment volume as Synvisc but provides the 6 mL of hylan G-F 20 in a single injection. Synvisc-One is also approved in the European Union and a number of Asian and Latin American countries. Nearly 10,000 patients have been treated with Synvisc-One since it was first approved last year. Full prescribing information is available at www. synvisc-one.com . To learn more, contact Genzyme Corporate Offices |
Biotherapeutic Thermogels
| BioSyntech, Inc., a biotechnology company developing biotherapeutic thermogels for regenerative medicine, announced that it will conduct an interim analysis of the available clinical data from 40 subjects who have completed their 12-month follow-up in the 80-subject trial for its cartilage repair device, BST-CarGel®. The company expects to have the results from this analysis available in the second quarter of 2009. The ongoing, randomized BST-CarGel® pivotal trial compares the treatment of cartilage lesions using BST-CarGel® applied following microfracture to treatment with microfracture alone as a control. The trial enrolled 80 subjects aged 18 to 55 years with focal cartilage lesions less than 10 cm2 located on the femoral condyles of the knee. Subjects were further stratified by their lesion type, either acute (ie, traumatic) or chronic (ie, degenerative). The primary endpoint for this trial is cartilage repair at 12 months, defined by the quantity and quality of the repaired tissue as measured with quantitative magnetic resonance imaging. Secondary endpoints are safety and knee-related pain, stiffness, and function as measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire. BioSyntech’s platform technology is a family of hydrogels called BST-Gel®, some of which are liquid at low temperature and solid at human body temperature. The company notes that these gels can be injected or applied to a specific local site and offer beneficial properties for the local repair of damaged tissue such as cartilage, bone, and chronic wounds and provide the benefit of avoiding invasive surgery. For additional information, visit www.biosyntech.com |