FDA Clears ION Stent from Boston Scientific

The latest generation of drug-eluting stent from Boston Scientific Corp. has been given the nod by the U.S. Food and Drug Administration (FDA). The ION Paclitaxel-eluting platinum chromium coronary stent system is the company’s third-generation drug-eluting stent technology.

The system incorporates a unique platinum chromium (PtCr) alloy designed specifically for coronary stenting. According to the company, the design offers greater strength in addition to enhanced deliverability and visibility. The thin-strut stent is designed for improved conformability, minimal recoil, and uniform lesion coverage and drug distribution.

“I look forward to using the ION stent in my daily practice, and I believe our patients will benefit from its improved acute performance,” said Louis Cannon, M.D., FACC, FACA, Heart and Vascular Institute program director at Northern Michigan Regional Hospital in Petoskey, Mich. “The platinum chromium 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.”

According to Cannon, the stent’s low-profile delivery system facilitates precise delivery of the stent across challenging lesions.

Company officials are enthusiastic about the device’s U.S. launch. In part, their optimism is based on a year’s worth of market experience in Europe, where the stent received its CE Mark in May last year. Outside the United States, including CE Mark countries, the ION Stent System is sold as the Taxus Element.

“The company has made significant investments in the platinum chromium alloy, and our success with the PtCr Stent Series in Europe and other international markets has confirmed that stent material really matters,” said Hank Kucheman, president of Natick, Mass.-based Boston Scientific’s Cardiology, Rhythm and Vascular division. “We believe the PtCr platform sets a new standard for drug-eluting stent performance and represents the future of coronary stenting.”

The ION stent was evaluated as part of the company’s 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 trial compared ION 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, the company reported.

“The positive clinical data from our PtCr Series trials support the acute performance benefits provided by our new platinum chromium stent platform,” said Keith D. Dawkins, M.D., chief medical officer for Boston Scientific’s Cardiology, Rhythm and Vascular Group. “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.”