Boston Scientific has announced FDA approval of its ION platinum chromium drug eluting coronary stent. The ION stent, which received European CE marking last May, is marketed internationally as the TAXUS Element. The ION improves on Boston Scientific’s line of PtCr stents through the use of a new design which provides greater strength and less recoil, in turn translating into better safety and efficacy.
From the press release:
The ION Stent has been evaluated in the PERSEUS trial, which reported 12-month results in March 2010, demonstrating positive safety and efficacy outcomes in workhorse lesions compared to the TAXUS® Express2® Stent System. The PERSEUS clinical program compared the ION Stent to prior-generation Boston Scientific stents in more than 1,600 patients in two parallel trials at 90 centers worldwide. In April 2011, results from an analysis of pooled patient-level data from 2,298 patients enrolled in the PERSEUS and TAXUS ATLAS clinical trials showed that the ION Stent demonstrated significantly lower rates of major adverse cardiac events, target lesion failure and myocardial infarction compared to the TAXUS® Liberte® Paclitaxel-Eluting Stent System.
Press release: Boston Scientific Announces FDA Approval and U.S. Launch of ION™ Platinum Chromium Stent System…
Flashback: Boston Scientific’s TAXUS Element Stent Gets CE Mark
