Coronary stents save thousands of lives each year by providing a structural support to reopen blocked or restricted arteries and allowing blood to recirculate to cardiac tissue.
A major limitation of current stents is radiopacity—the lack of visibility in x-rays—which makes it difficult to see the stent for proper placement. The platinum-chromium alloy, developed at National Energy Technology Laboratory (NETL), is a stainless-steel formulation with a significant concentration of a highly radiopaque element (platinum) that makes it easier for coronary specialists to see the stent in the catheter during insertion, placement, and expansion. This alloy also increases the stent’s corrosive resistance, strength, and flexibility—all of which offer positive benefits to patients and cardiovascular surgeons.
Scientists from NETL worked closely with their counterparts from commercialization partner, Boston Scientific Corporation, to perform innovative alloy formulation and primary material process development. Boston Scientific utilized the improved alloy performance to develop new coronary stent products with superior properties compared to existing stainless-steel stents.
Global sales since market entry have exceeded $1 billion, and the stent will soon be sold in China, which is the largest stent market in the world.
After a lengthy series of clinical trials, Boston Scientific received foreign regulatory market approval in November 2009, and the new coronary stents were marketed as the PROMUS® ELEMENT™ in Europe and the rest of the world. Boston Scientific’s stents have gained a 45-percent market share using the alloy, and the company plans to use it exclusively in all of its stents. In early 2011, market approval was received from U.S. and Canadian regulatory agencies. In North America, the stents are marketed under the ION™ brand name. Global sales since market entry have exceeded $1 billion, and the stent will soon be sold in China, which is the largest stent market in the world. R&D Magazine recognized the team’s effort by selecting them as a winner of the 2011 R&D 100 Award.