October 18, 2011 — Boston Scientific Corp. has begun a phased launch of its Promus Element everolimus-eluting platinum chromium coronary stent system in China. The launch campaign will be expanded within the country based upon receipt of subsequent provincial reimbursement approvals.
The company previously received registration approval for the Promus Element from the State Food and Drug Administration (SFDA) of the People's Republic of China.
The product represents the company's third-generation drug-eluting stent (DES) technology, which incorporates a novel platinum chromium (PtCr) alloy, innovative stent design and advanced catheter delivery system. It offers greater strength, enhanced deliverability and exceptional visibility, and 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.
"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," said Runlin Gao, M.D., of the Cardiovascular Institute and Fu Wai Hospital in Beijing, and principal investigator of the PLATINUM China 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."
With the world's largest population, China represents one of the world’s fastest-growing DES markets. The company estimates the number of coronary drug-eluting stents implanted there in 2011 will be approximately 560,000. It also anticipates annual market growth exceeding 20 percent, making it the second-largest DES market worldwide after the United States.
In July, the company's board of directors approved a five-year, $150 million investment in China to establish a local, wholly owned manufacturing facility. It would focus on serving Chinese market needs and developing a training center for Chinese healthcare providers.
Because of this increased investment, as well as current and anticipated initiatives, Boston Scientific indicated it expects to increase its Chinese revenues to more than $500 million exiting 2016. The company also estimated its target market in China currently exceeds $1 billion and is growing approximately 20 percent annually.
PLATINUM clinical program
The PLATINUM China post-SFDA approval clinical trial is comparing the Promus Element to the Taxus Liberte paclitaxel-eluting coronary stent in the treatment of patients with a single de novo atherosclerotic lesion. It is a prospective, randomized trial that will enroll 500 patients at 15 sites in China.
In addition, the Promus Element is being evaluated in a separate PLATINUM clinical program, which includes five multi-center studies totaling more than 1,800 patients worldwide. Thirty-day and nine-month clinical and angiographic outcomes presented in September 2010 supported the safety and efficacy of the stent.
In April 2011, 12-month results announced from the PLATINUM Workhorse randomized, controlled trial demonstrated the clinical non-inferiority of the Promus Element in comparison to the Promus stent in treating de novo coronary artery lesions. The Promus Element also showed a procedural benefit of reduced rates of unplanned (bail-out or emergency) stenting.
In the United States, the Promus Element is an investigational device, limited by applicable law to investigational use and not available for sale.
For more information: www.bostonscientific.com