Leading medical devices player Boston Scientific (BSX) received approval from the US Food and Drug Administration (FDA) for its Ion paclitaxel-eluting platinum chromium coronary stent system.
Along with approval, the company also announced the launch of the product in the US. This will be a major boost for Boston Scientific’s biggest segment, Cardiovascular, which has been recording lower sales in the last few quarters.
Outside the US, the Ion stent is commercialized as the Taxus Element stent. In March 2010, Boston Scientific presented encouraging 12-month data from the Perseus trial. The trial compared the safety and effectiveness of the Ion stent compared to the prior-generation Taxus Express stent in more than 1,600 patients.
Moreover, 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 demonstrated that the Ion stent resulted in lower rates of major adverse cardiac events, target lesion failure and myocardial infarction compared to the Taxus Liberte stent. While the US launch of Ion is quite inspiring, the company is working towards its launch in Japan, which is expected in late 2011 or early 2012.
Boston Scientific has an agreement with Abbott Laboratories (ABT) through which it markets Abbott’s everolimus eluting stent, Xience, up to the second quarter of 2012 under the brand name Promus in the US and Japan. The company launched the internally-developed Promus Element stent system in the EMEA region and certain Inter-Continental countries in the fourth quarter of 2009.
In September 2010, the company received CE Mark approval for expanded use of the Promus Element stent system in diabetic and heart attack patients. Promus Element is expected to be launched in the US and Japan in mid-2012.
Boston Scientific’s Cardiovascular segment recorded a 5% year-over-year decline in sales to $811 million in the first quarter of fiscal 2011. While sales from Interventional Cardiology declined 8% to $635 million, Peripheral Interventions increased 7% to $176 million.
Global sales of coronary stent systems (within Interventional Cardiology) at $409 million declined 7.9%, driven by lower sales of both drug-eluting stents (DES, 6.9% to $379 million) and bare-metal stents (18.9% to $30 million). We believe the US launch of Ion should provide some cushion to the declining sales of DES. Moreover, the company maintained its leadership position in the DES market with a 36% share globally and 46% in the US.
We are currently ‘Neutral’ on Boston Scientific.
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