FDA approves ION Platinum Chromium stent system


Boston Scientific announced on 25 April 2011 the FDA approval and launch of its third-generation ION Paclitaxel-Eluting Platinum Chromium coronary stent system. The system incorporates a unique platinum chromium (PtCr) alloy designed specifically for coronary stenting and is intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease.

This stent system features an innovative PtCr alloy and new stent design to offer greater strength, enhanced deliverability and exceptional visibility. The thin-strut stent is designed for improved conformability, minimal recoil, and uniform lesion coverage and drug distribution. The advanced low-profile delivery system facilitates precise delivery of the stent across challenging lesions.


“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, Heart and Vascular Institute Programme director at Northern Michigan Regional Hospital in Petoskey, USA. “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.”


“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, executive vice president and group president, Cardiology, Rhythm and Vascular for Boston Scientific. “We believe the PtCr platform sets a new standard for drug-eluting stent performance and represents the future of coronary stenting.”


The ION stent offers physicians and their patients the broadest size matrix on the market, and includes both monorail and over-the-wire versions, with sizes ranging in diameter from 2.25mm to 4.00mm and lengths of 8mm to 38mm.


Outside the US, including CE mark countries where it was approved in May 2010, the ION stent system is commercialised as the Taxus Element Paclitaxel-Eluting coronary stent system. The ION stent is backed by the proven safety and efficacy of the TAXUS clinical programme, which spans 10 years of research in nearly 50,000 patients in 28 pre- and post-market studies.


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 programme compared the ION stent to prior-generation Boston Scientific stents in more than 1,600 patients in two parallel trials at 90 centres 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.


“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, senior vice president and 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.”


In October 2009, the company received CE mark approval for the Promus Element Everolimus-Eluting stent system. The company anticipates FDA approval for the Promus in mid 2012. The product incorporates the same platinum chromium alloy, innovative stent design and advanced catheter delivery system of the ION stent system. In the US, the Promus Element stent system is an investigational device, limited by applicable law.