New medgadget intern Justin Barad points out that the FDA just gave Nexa Orthopedics clearance to market their new pyrolytic carbon Carpometacarpal Implant (CMI). The implant is for the basal thumb joint and is intended for patients with rheumatoid arthritis, osteoarthritis, and other bone degenerative conditions.
While there are a lot of pyrolytic carbon joint replacements on the market today, it’s worthwhile to take a step back and appreciate how pyrolytic carbon revolutionized the medgadget world. It was brought into the medical world as most biomaterials are: by chance. Here is an excerpt from a General Atomic (where pyrolytic carbon’s medical potential was discovered):
Dr. Bokros was using pyrolytic carbon to coat nuclear fuel particles for the GA gas-cooled nuclear power reactors more than 30 years ago. He stumbled upon its potential for medical uses through what has been called ‘a lesson in serendipity.’ In 1966, Bokros read an article by Dr. Vincent Gott, who had been testing carbon-based paint as a blood compatible coating for artificial heart components. Bokros contacted Gott who initiated the collaboration that resulted in making heart valve replacements a practical reality and common-place procedure.
In the 1960’s artificial heart valves constructed from plastics and metals suffered from short-term failures due to wearing-out or because of blood clotting. Gott was searching for a material to use in artificial heart valves that did not provoke blood clots and had the mechanical durability to endure for a recipient’s lifetime. Pyrolytic carbon, from GA, met both of his needs. However, the initial material used to coat nuclear fuel particles had the needed blood compatibility, but not the durability. GA initiated a development project headed by Dr. Bokros to add the needed durability to the material. This endeavor was successful and the biomedical grade of pyrolytic carbon, known as Pyrolite, was rapidly incorporated into the existing heart valve designs.
After 30 years, pyrolytic carbon remains the most widely used material for mechanical heart valves. It has been used in more than 4 million implants in more than 25 different valve designs for a clinical experience on the order of 18 million patient-years. No other material used for long-term blood contacting implants can boast of such a successful clinical experience.
So, three cheers for pyrolytic carbon. With it, we are one step closer to making the six-million-dollar man a reality (but he’ll probably cost even more).
Read the press release here…