BSX Begins the Phased Rollout of New Stent in China

Boston Scientific Corp. has begun what it’s calling a “phased” launch of its Promus Element stent systems in China. The release of the device will be expanded within the country based upon receipt of subsequent provincial reimbursement approvals.

The company previously received registration approval for the device from China’s State Food and Drug Administration.

The product is BSX’s third-generation drug-eluting stent (DES) technology. It incorporates a platinum chromium alloy, innovative stent design and advanced catheter delivery system. According to the company, these factors combine to offer “greater strength, enhanced deliverability and exceptional visibility, and it is designed for improved conformability, minimal recoil, and uniform lesion coverage and drug distribution.”

With the world’s largest population, China represents one of the fastest-growing DES markets. Boston Scientiic estimates the number of coronary drug-eluting stents implanted there in 2011 will be approximately 560,000, with annual market growth exceeding 20 percent, making it the second-largest DES market worldwide after the United States.

“The Chinese government has announced its intention to spend $125 billion on its healthcare system in the next five years, and the launch of our advanced coronary stenting technology in China reflects our intention to tap into its expanding, promising DES market,” said Larry Neumann, senior vice president and president, emerging markets at Boston Scientific. “We are making significant investments in our sales, distribution and clinical infrastructure in China and this important launch reflects our goal to win global market share.”

In July, the company initiated a five-year, $150 million investment in China to establish a local, wholly owned manufacturing facility focused on serving Chinese market needs and developing a training center for Chinese healthcare providers. As a result of this increased investment, as well as current and anticipated initiatives, Boston Scientific expects to increase its revenues in China to more than $500 million by the end of 2016. The company also estimated that its target market in China currently exceeds $1 billion and is growing approximately 20 percent annually.

Post-approval trials of the Promus Element are ongoing in China.

The Promus Element is an investigational device in the United States. The company expects approval by mid-2012.