Bio DG announced on 10 September 2012 that its patent for a novel metal system for use as biodegradable material in developing implantable medical devices was granted by the US Patent Office on 21 August 2012.
Bio DG’s first-of-its-kind biodegradable alloys are primarily metallic and provide high strength when first implanted, then gradually erode in a predictable and biocompatible manner.
These alloys are engineered to address the limitations of current biodegradable materials such as polymers, as well as non-biodegradable materials such as stainless steel and titanium, that are used in implantable medical devices. Bio DG alloys may be formed into any shape, such as screws, plates, sutures, and stents, using common forming techniques, making them ideal for use in a wide range of medical devices across multiple market segments. Agreements are currently in place for this patented technology to be used in the development of products within some key segments.
The alloys are austenitic so that they will not react in a magnetic field and formulated from well-tolerated elements so as not to generate a toxic reaction. Bio DG materials have the strength of a steel alloy and are much stronger than a polymer implant.
“The concept of a non-magnetic biodegradable metal which can be crafted to perform its purpose of coaptation of tissue until fully healed, then eliminated from the body, is a very exciting concept,” stated Herbert H Dardik, chief Vascular Surgery, Englewood Hospital, Englewood, USA. “I can see that this new technology will greatly expand clinical applications where we now limit use of metal sutures and staples, as well as where implants made from polymer technologies are not ideal.”
“These alloys have tremendous potential,” Bio DG chief operating officer Herbert R Radisch, Jr stated. “Within the orthopaedic space they can replace stainless steel and titanium alloy devices meant for temporary or semi-permanent implants. Within the cardiovascular space they can be used to develop strong biodegradable stents that have the ability to degrade over a specific time period. And within the suturing/stapling space, they can be used to develop an implantable surgical staple that does not require a second surgical intervention for removal. Devices made from this patented technology clearly have the potential to improve long term patient outcomes across a range of therapeutic areas.”
Bio DG alloys are engineered to dissolve from the exterior surfaces without compromising the internal structure, thus retaining strength of the remaining undissolved portion of the implant throughout the degradation period. The alloys are non-toxic to the host body. They are ideal for medical devices that must exhibit high strength and are implanted such that removal is not ideal and instead biodegradation is preferred.