FDA OKs Boston Sci's ION stent system

Boston Scientific has launched its ION paclitaxel-eluting platinum chromium coronary stent system in the U.S. after receiving the FDA's blessing. The ION system is sold outside the U.S. as the Taxus Element paclitaxel-eluting coronary stent system. 

The ION system features a platinum chromium alloy and new design to offer greater strength, enhanced deliverability and exceptional visibility, the company says in a statement.  It is backed by the Taxus clinical program, which spans 10 years of research in nearly 50,000 patients in 28 pre- and post-market studies, the company adds.

"The platinum chromium alloy represents a leap forward in materials technology and will address many of the limitations found in older stent alloys, says Louis Cannon, Heart and Vascular Institute Program Director at Northern Michigan Regional Hospital in Petoskey, MI. "Exceptional stent deliverability offers cardiologists the potential to treat patients with difficult-to-reach lesions." 

The ION Stent has been evaluated in the PERSEUS trial, which compared ION to prior-generation Boston Scientific stents in more than 1,600 patients in two parallel trials. Results from an analysis of pooled patient-level data from 2,298 patients enrolled in the PERSEUS and TAXUS ATLAS trials showed 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.

- read Boston Scientific's release