The majority of cardiologists in the U.S., Europe, South Korea, China, India, Middle East and Africa would use a bioabsorbable stent for the treatment of coronary angioplasty. In contrast, the majority of cardiologist in Japan and Latin America would not, according to a survey by Vancouver-based iData Research.
Bioabsorbable stents are constructed from a polymer which naturally degrades in the body over time, releasing the drug contained within. After the drug is released, there will be little or nothing of the original stent remaining, thereby decreasing the incidence of late stent thrombosis. Theoretically, these stents should have low rates of both restenosis and thrombosis because a device is not present in the vessel for a long period of time.
The survey was conducted at Transcatheter Cardiovascular Therapeutics (TCT) meeting in September in Washington, D.C., and includes the responses from hundreds of physicians including cardiologists, interventional radiologists, cardiac surgeons and general physicians.
"The survey provided dramatic differences between geographical regions in usage trends," says Kamran Zamanian, PhD, CEO of iData. "Cardiologists in the U.S. and Europe are more willing to use new technologies such as bifurcated and bioabsorbable stents, while Japanese and Latin American cardiologists are more resistant, citing the lack of long-term clinical data, early recoil and technical challenges as drawbacks to these technologies."
Bioabsorbable stents have been more difficult to perfect than initially expected, according to iData. Problems with varying rates of degradation and uneven drug release have delayed the introduction of these devices into the market. As a result, the FDA is requiring extensive animal and human study data before considering the approval of this type of technology.
Results from clinical trials, such as the second phase of Abbott Laboratories's ABSORB trial, showed a low rate of major acute coronary events and no evidence of the formation of thrombus or the need for a repeat procedure when using the bioabsorbable stents. These positive results should help overcome some of the apprehension seen in Japanese and Latin American regions.
An accompanying report from iData on the interventional cardiology market found that bioabsorbable stents are expected to enter the European market by 2013 and the U.S. and Japanese markets thereafter. The U.S. market is estimated to quickly reach almost $750 million with companies such as Abbott, Biosensors International and REVA Medical emerging as leaders.
The report estimates that the U.S. market for interventional cardiology is expected to reach almost $5 billion by 2017, with increasing drug-eluting stent sales and the emergence of bioabsorbable and bifurcated stents fueling market growth.
iData Research is an international market research and consulting firm focused on providing market research for the medical device, dental and pharmaceutical industries.