Boston Scientific unveils new stent system
Boston Scientific launched its platinum chromium Taxus Element paclitaxel-eluting coronary stent system in select international markets. The Taxus Element stent features a new platinum chromium alloy engineered for coronary stent applications and represents the company's third-generation drug-eluting stent (DES) technology.
According to the Natick, Mass.-based company, the Element stent series consists of three distinct versions: the paclitaxel-eluting Taxus Element stent, the everolimus-eluting Promus Element stent and the bare-metal Element stent. All three versions of the Element stent are built on the platinum chromium platform. The Element platform also features new stent architecture with thinner struts and a lower profile, designed to improve radial strength, recoil and angiographic visibility, Boston Scientific said.
The Taxus Element is currently being studied in the PERSEUS clinical trial program, which compares the Taxus Element to the Taxus Express2 stent system. The program includes the PERSEUS Workhorse and the PERSEUS Small Vessel arms. Both have finished recruiting patients and are estimated to be completed by the end of the year. The Promus Element is currently being studied in the PLATINUM clinical trial program, which compares Promus Element to the original Promus, and is actively enrolling patients in the U.S., Europe and Japan.
The company said it is anticipating CE Mark approval for both the Taxus Element and Promus Element stent systems in the 2009 fourth quarter.
The company said that its Taxus Element and Promus Element DES systems are CE mark pending, while the Element bare-metal stent is under development. In the U.S., the Taxus Element stent and Promus Element stent are investigational devices and are limited by applicable law to investigational use only. The stents are not available for sale in the EEA (European Economic Area), U.S. and Japan.
According to the Natick, Mass.-based company, the Element stent series consists of three distinct versions: the paclitaxel-eluting Taxus Element stent, the everolimus-eluting Promus Element stent and the bare-metal Element stent. All three versions of the Element stent are built on the platinum chromium platform. The Element platform also features new stent architecture with thinner struts and a lower profile, designed to improve radial strength, recoil and angiographic visibility, Boston Scientific said.
The Taxus Element is currently being studied in the PERSEUS clinical trial program, which compares the Taxus Element to the Taxus Express2 stent system. The program includes the PERSEUS Workhorse and the PERSEUS Small Vessel arms. Both have finished recruiting patients and are estimated to be completed by the end of the year. The Promus Element is currently being studied in the PLATINUM clinical trial program, which compares Promus Element to the original Promus, and is actively enrolling patients in the U.S., Europe and Japan.
The company said it is anticipating CE Mark approval for both the Taxus Element and Promus Element stent systems in the 2009 fourth quarter.
The company said that its Taxus Element and Promus Element DES systems are CE mark pending, while the Element bare-metal stent is under development. In the U.S., the Taxus Element stent and Promus Element stent are investigational devices and are limited by applicable law to investigational use only. The stents are not available for sale in the EEA (European Economic Area), U.S. and Japan.