Glasgow/Basel, 8 October 2010 – At the 19th annual meeting of the European Association for Osseointegration (EAO) in Glasgow, Straumann announced the market introduction of Straumann® MembraGel™, its new-generation membrane for use in guided oral bone regeneration (GBR) procedures.
Straumann MembraGel is a polyethylene glycol (PEG) membrane that is applied as a liquid and sets in situ. As this is an innovative technology requiring different handling to conventional membranes, Straumann is combining the launch with an education program that includes hands-on product training. The company is making the product available only to dental professionals who have participated in the program.
“Straumann MembraGel offers a unique combination of benefits and we are convinced that it will set new standards in surgical implantology. Throughout development, we have worked closely with leading independent experts and have decided to launch the product in combination with an education program because we want customers to achieve optimum results from the outset. This is the appropriate way to introduce new technologies and shows that we take our responsibilities as an innovator seriously”, explained Dr Sandro Matter, Executive Vice President of Products at Straumann.
A large clinical need
Market research2 suggests that at least one in four implant procedures requires bone augmentation either prior to, or concurrent with, implant placement. Guided bone regeneration involves the use of a barrier membrane to help stabilize the bone graft and prevent unwanted growth of soft-tissue into the defect. The broad use of membranes explains why the global market for these products is estimated to be worth CHF 200 million3.
Multiple benefits in one product
Commonly used conventional membranes are supplied as prefabricated sheets and have to be cut to fit the defect – often using a template. In some cases, the membrane also needs to be secured by pinning. Furthermore, non-resorbable membranes need to be surgically removed after the healing process has taken place.
Based on hydrogel technology, Straumann MembraGel is applied in liquid form and molds to the defect precisely. Within 20-50 seconds after application, the liquid components solidify, stabilizing the bone graft and providing an effective barrier to tissue infiltration. Preclinical studies have shown that the surgical site is protected over the period required for bone formation4 with no abnormal soft-tissue reaction5. Straumann MembraGel subsequently biodegrades1. The product is thus designed to achieve undisturbed bone regeneration, which is a prerequisite for optimal clinical and esthetic outcome.
Straumann MembraGel has completed preclinical and clinical trials including head-to-head comparisons with conventional materials. The results of a randomized, controlled clinical trial6 demonstrate considerably simplified clinical handling and reductions in application time as well as effective bone augmentation and excellent defect resolution, which are important in achieving an esthetic outcome and good soft tissue healing.
Further clinical data have been collected in an ongoing ‘non-interventional’ study and a multicenter clinical trial. Data from the clinical program, which includes more than 40 centers in Europe and North America, are being presented in Glasgow in the course of the EAO.
Straumann MembraGel is being launched initially in key European markets, North America and Australia, where it has received regulatory approvals/clearances.
1 Wechsler S, Fehr D, Molenberg A, Raeber G, Schense JC, Weber FE. A novel, tissue occlusive poly(ethylene) glycol hydrogel material. J Biomed Mater Res A 2008;85:285-92.
2 iData. US market for dental bone graft substitutes and other biomaterials, 2007.
3 Countries covered by Millenium Research Group 2009, Straumann estimate
4 Thoma DS, Halg GA, Dard MM, Seibl R, hammerle CH, Jung RE. Evaluation of a new biodegradable membrane to prevent gingival ingrowth into mandibular bone defects in minipigs. Clin Oral Implants Res 2009;20:7–16.
5 Jung RE, Lecloux G, Rompen E, Ramel CF, Buser D, Hammerle CH. A feasibility study evaluating an in situ biodegradable membrane for guided bone regeneration in dogs. Clin Oral Implants Res 2009;20:151-161.
6 Jung RE, Hälg GA, Thoma DS, Hämmerle CH. A randomized, controlled clinical trial to evaluate a new membrane for guided bone regeneration around dental implants. Clin Oral Implants Res 2009;20:162-8.