BioMg 250 is a breakthrough magnesium (Mg) alloy technology developed by nanoMag, LLC of Livonia, MI. It combines the strength and handling properties of metal with complete absorption.
Mg is a common element in the body and breaks down through a natural degradation process as it is absorbed and is removed from the body (more natural compared to hydrolysis of biocomposite / similar materials). Mg allows for many engineering advantages due to its high strength.
This exclusive and proprietary magnesium technology provides optimal characteristics not found in existing soft tissue fixation devices, including high strength, controlled absorption, while promoting regrowth of host tissue. The method of manufacturing provides mechanical strength at least 2X that of PEEK, a well-known performance polymer used in similar indications.
Through an exclusive worldwide license, MDC is developing devices of BioMg 250 initially for interference screws for anterior cruciate ligament (ACL) repair along with other applications in knee and shoulder sports medicine and foot & ankle repair.
Mg – Clinical Application / History
Use of Mg-based alloys has a history of more than a century. Use of unspecified Mg alloy as wire for vascular closure was first reported by Huse in human patients in 1878 (1). Payr introduced the concept of Mg plates and sheets to the treatment of joint disease in 1900 (2), which was followed by human implantation of Mg sheets into temporarily stabilized joints by Chlumsky, finding successful preservation of 2mm wide joint space through 8-month follow-up (3). Lambotte continued research in orthopedic applications in the 1930’s in both animals and humans, eventually using an Mg alloy nail for the treatment of supracondylar fractures in children, with good results (4). Maier investigated the use of magnesium devices in humeral fractures of two humans, with good results after 14-year follow-up (5). In 1948, Troitskii and Tsitrin reported on 34 human cases for treatment of pseudoarthrosis with a plate/screw construct made from Mg-Cd alloy (6).
While significant advantages were found in these applications, especially considering the use of devices in children, the continued difficulty was experienced finding Mg alloys with proper mechanical properties for the indications, as well as achieving greater control of the hydrogen production during absorption of the implants. Substantial work in the use of Mg alloys in medical applications was reinitiated by Heublein et al in 2000 (7), particularly for vascular applications. This work resulted in the development of a cardiac stent, multiple human trials, and is currently undergoing clinical trial in 46 humans as a drug-coated stent with favorable results after 12 months follow-up (8).
In June 2014, Transluminal Technologies received CE mark approval for marketing of its absorbable vascular closure device using Mg alloy. Transluminal claims this approval was granted following good results following human clinical trials and notes a cohort of at least 14 patients in 2010. No further data or publication reporting the use and results of the device can be found (9).
In modern orthopedic applications, the MAGNEZIX® screw (Syntellix AG), indicated for reconstruction of hallux valgus deformity has been granted CE mark for marketing in Europe using a MgYREZr alloy. In the randomized trial of 26 humans, the Mg alloy screw was found to be clinically equivalent to titanium screws, and no adverse body reactions were detected (10).
1. Huse EC. A new ligature? Chicago Med J Exam 1878:172-2.
2. Payr E. Beiträge zur Technik der Blutgefäss- und Nervennaht nebst
Mittheilungen über die Verwendung eines resorbirbaren Metalles in der Chirurgie. Arch Klin Chir 1900;62:67–93.
3. Chlumsky ́ V. Über die Wiederherstellung der Beweglichkeit des Gelenkes bei Ankylose. Centralblatt Chir 1900;27(37):921–5.
4. Verbrugge J. Le matériel métallique résorbable en chirurgie osseuse. Presse Med 1934;23:460–5.
5. Maier O. Über die Verwendbarkeit von Leichtmetallen in der Chirurgie (metallisches Magnesium als Reizmittel zur Knochenneubildung). Deut Z Chir 1940;253:552–6.
6. Tpobwrbq BB, Wbnpby LH. Osteosynthesis with metal alloy as a material for bonding bone in fractures. Xbpypubz 1948;8:41–4.
7. B. Heublein, R. Rohde, M. Niemeyer, V. Kaese, W. Hartung, C. Rocken. Degradation of metallic alloys – a new principle in stent technology? J Am Coll Cardiol, 35 (2000), pp. 14a–15a.
8. M. Haude, R. Erbel, P. Erne, S. Verheye, H. Degen, D. Bose, et al. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12-month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial. Lancet, 381 (2013), pp. 836–844.
9. Manufacturer’s website: www.transluminal.net
10. Windhagen H, Radtke K, Weizbauer A, Diekmann J, Noll Y, Kreimeyer U, et al. Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short-term results of the first prospective, randomized, controlled clinical pilot study. Biomed Eng Online 2013,12:62-72.