Alloy Improves Coronary Stent's Acute Performance

This past April the U.S. Food and Drug Administration (FDA) approved the ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Boston Scientifics’ third-generation drug-eluting stent technology. The ION Stent System incorporates a platinum chromium (PtCr) alloy designed specifically for coronary stenting, and intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease.

With the PtCr alloy and the new stent design, the ION Stent System delivers greater strength, enhanced deliverability, and exceptional visibility. The thin-strut stent delivers a design for improved conformability, minimal recoil, and uniform lesion coverage and drug distribution. In addition, the advanced, low-profile delivery system facilitates precise delivery of the stent across challenging lesions.

Properties of platinum chromium that enhance the stent’s function are the fact that:

• Platinum has more than two times the density of iron or cobalt, resulting in exceptional radiopacity characteristics;
• Platinum is evenly distributed throughout the alloy resulting in appropriate visibility; and
• When platinum is combined with stainless steel, the overall strength of the alloy is increased, enabling thinner struts without compromise to strength, flexibility, or visibility.

“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,” says 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 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. 

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 program compared the ION Stent 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 System.

“The positive clinical data from our PtCr Series trials support the acute performance benefits provided by our new platinum chromium stent platform,” says Keith D. Dawkins, M.D., 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, Boston Scientific received CE Mark approval for the PROMUS Element Everolimus-Eluting Stent System. Boston Scientific anticipates FDA approval for the PROMUS Element Stent System 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 United States, the PROMUS Element Stent System is an investigational device, limited by applicable law to investigational use only and not available for sale.


Boston Scientific
Natick, MA
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