Stents, which are typically inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, have traditionally been made from metal mesh and remained in the body permanently (or until later removed by surgical intervention). Recently, biodegradable stents (also called bioresorbable or bioabsorbable stents) have been developed. These stents serve the same purpose as traditional stents but are manufactured from materials that may dissolve or be absorbed in the body.
The Food and Drug Administration (FDA) announced in mid-2016 that it had approved the first fully absorbable stent to treat coronary artery disease. According to the FDA, the stent (ABSORB GT1 BVS, which is manufactured by Abbott Vascular and pictured below) is gradually absorbed by the body in approximately three years following implantation. Abbott reportedly received European approval for the ABSORB BVS product in 2011.
According to some commentators, biodegradable stents, like the ABSORB BVS, are the way of the future and will eventually replace conventional metallic stents. This hypothesis is consistent with research conducted by Transparency Market Research. Transparency Market Research recently published a report (Biodegradable Stents Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2016 – 2024) which projects the global market for biodegradable stents to grow from $18 Million US dollars in 2015 to $1.7 Billion US dollars by 2024 (a short 9 years). This amounts to a compound annual growth rate (CAGR) of over 30%. According to the report:
[t]he biggest advantage of [biodegradable] stents is that they get entirely absorbed in the vessels over a period of time, reducing the risk of complications or infections. This advantage is the primary reason for the growth of the global biodegradable stents market.
The report goes on to state that:
[a]s compared to predecessors of biodegradable stents, the newer technology has significantly reduced the risk of thrombosis, . . . in-stent restenosis, dual anti-platelet therapy, and second surgery for removal of the stent. These factors have played a pivotal role in shaping the trajectory of the global market in a positive direction over the past few years. The efficiency of biodegradable stents has won the market numerous consumers in the recent past. Thus, several patients and cardiologists have shown a keen interest in the uptake of biodegradable stents in the treatment of coronary and peripheral artery diseases.
Other manufacturers of biodegradable stents reportedly include Elixir Medical, Biotronik, Kyoto Medical Planning, Micell Technologies, and Reva Medical. Based on this industry’s projected growth, it appears that additional companies are likely to enter the biodegradable stent market and the United States Patent Office may see a marked increase in the number of patent application filings that are directed to biodegradable stents and other biodegradable medical devices.