FDA Approves Boston Scientific's Ion PtCr Stent System

April 25, 2011—Boston Scientific Corporation (Natick, MA) announced US Food and Drug Administration (FDA) approval and the launch of the Ion paclitaxel-eluting platinum chromium (PtCr) coronary stent system. The Ion stent will be available with sizes ranging in diameter from 2.25 to 4 mm and lengths from 8 to 38 mm, and includes both monorail and over-the-wire versions.

Boston Scientific Corporation's third-generation drug-eluting stent technology incorporates several advances over its previous devices.  The device's PtCr alloy is designed specifically for coronary stenting and intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease. The Ion's new stent design offers greater strength, deliverability, and visibility. The thin-strut stent is designed for improved conformability, minimal recoil, and uniform lesion coverage and drug distribution. The low-profile delivery system facilitates precise delivery of the stent across challenging lesions, the company stated. 

“I look forward to using the Ion stent in my daily practice, and I believe our patients will benefit from its improved acute performance,” commented Louis Cannon, MD. “The PtCr alloy represents a leap forward in materials technology and will address many of the limitations found in older stent alloys. Exceptional stent deliverability offers cardiologists the potential to treat patients with difficult-to-reach lesions.”

The Ion stent system is commercialized as the Taxus Element paclitaxel-eluting coronary stent system outside of the United States, including in countries that recognize CE Mark approval, which was granted in May 2010. The device's safety and efficacy was demonstrated in the 10-year TAXUS clinical program. The PERSEUS clinical program compared the Ion stent to previous-generation Boston Scientific Corporation stents in more than 1,600 patients in two parallel trials at 90 centers worldwide.

Principal investigator Dean J. Kereiakes, MD, presented the Ion's 12-month results in the PERSEUS trial at the American College of Cardiology's 59th annual scientific session in Atlanta in March 2010, which was reported in Cardiac Interventions Today. The Ion demonstrated positive safety and efficacy outcomes in workhorse lesions compared to the company's Taxus Express² stent system.

On April 3, 2011, Dr. Kereiakes presented results from an analysis of the PERSEUS and TAXUS ATLAS clinical trials results on at the American College of Cardiology's 60th annual scientific session in New Orleans, which was also reported in Cardiac Interventions Today. The pooled patient-level data from 2,298 patients enrolled in the two trials showed that the Ion stent demonstrated significantly lower rates of major adverse cardiac events, target lesion failure, and myocardial infarction compared to the company's Taxus Liberté paclitaxel-eluting stent system.

Boston Scientific Corporation received CE Mark approval for the Promus Element everolimus-eluting stent system in October 2009 and the company anticipates FDA approval for the Promus Element in mid 2012. The Promus Element incorporates the same PtCr alloy, stent design, and catheter delivery system as the Ion stent system. In the United States, the Promus Element stent system is an investigational device, limited to investigational use only and is not available for sale, the company advised.