This article is more than 5 years old. Information may no longer be current.
FDA approves third-generation drug-eluting stent
Click Here to Manage Email Alerts
Almost a year after receiving CE mark approval for the device, Boston Scientific announced the FDA approval and launch of its ION paclitaxel-eluting platinum chromium coronary stent system.
According to a press release, the ION system is a third-generation drug-eluting stent that features a platinum chromium alloy specifically designed for coronary stenting. The system, according to the manufacturer, will provide physicians with the broadest size matrix on the market, including both monorail and over-the-wire versions, with sizes ranging in diameter from 2.25 to 4 mm and lengths of 8 to 38 mm.
“The positive clinical data from our [Platinum Chromium] Series trials support the acute performance benefits provided by our new platinum chromium stent platform,” Keith D. Dawkins, MD, senior vice president and chief medical officer for Boston Scientific’s Cardiology, Rhythm and Vascular Group, said in the press release. “The PERSEUS data confirmed that the proven TAXUS drug and polymer combination has been successfully transferred to the advanced ION Stent platform with excellent performance and comparable safety and efficacy.”
Commercialized as the Taxus Element paclitaxel-eluting platinum chromium coronary stent system outside of the United States, the ION system is the end result of 10 years of research in nearly 50,000 patients in 28 pre- and post-market studies.
 |
Follow CardiologyToday.com on Twitter. |