Boston Scientific Launches Promus Element DES In China

October 17, 2011—Boston Scientific Corporation (Natick, MA) announced that it has begun a phased launch of its Promus Element everolimus-eluting platinum chromium coronary stent system in China. The launch will be expanded within the country based upon receipt of subsequent provincial reimbursement approvals. Boston Scientific previously received registration approval for the Promus Element stent system from the State Food and Drug Administration (SFDA) of the People's Republic of China.

According to Boston Scientific, the Promus Element is the company's third-generation drug-eluting stent (DES) technology. It incorporates a platinum chromium alloy and is designed for improved conformability, minimal recoil, and uniform lesion coverage and drug distribution. A low-profile delivery system facilitates precise delivery of the stent across challenging lesions. In the United States, the Promus Element stent is an investigational device, limited by applicable law to investigational use and not available for sale, advised the company.

"The Promus Element stent represents a true next-generation DES technology and its unique platinum chromium alloy addresses many of the limitations found in older stent alloys," commented Runlin Gao, MD, Principal Investigator of the PLATINUM trial. "In my clinical experience, I have found it to offer performance advantages in flexibility, visibility, and deliverability. It will be an important additional treatment option for the growing incidence of coronary artery disease in China."

Boston Scientific stated that the PLATINUM China post-SFDA approval clinical trial is comparing the Promus Element stent to the company's Taxus Liberté paclitaxel-eluting coronary stent in the treatment of patients with a single de novo atherosclerotic lesion. The prospective, randomized trial will enroll 500 patients at 15 sites in China.

The company noted that China represents one of the world's fastest-growing DES markets, estimating that approximately 560,000 coronary DES will be implanted there in 2011, with an annual increase of 20%. Also, the Chinese government has announced its intention to spend $125 billion on its health care system in the next 5 years.

In July, Boston Scientific's Board of Directors approved a 5-year, $150 million investment in China to establish a local, wholly owned manufacturing facility focused on serving Chinese market needs and developing a world-class training center for Chinese health care providers.