The State Food and Drug Administration (SFDA) of the People’s Republic of China has given registration approval to Boston Scientific to market its Promus Element everolimus-eluting platinum chromium coronary stent system. The company has begun a phased launch of this stent that will be expanded within the country based upon receipt of subsequent provincial reimbursement approvals.
The Promus Element 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. 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, 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, with annual market growth exceeding 20%, making it the second-largest DES market worldwide after the United States.
“The Chinese government has announced its intention to spend US$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.
In the USA, the Promus Element stent is an investigational device, limited by applicable law to investigational use and not available for sale.
PLATINUM clinical programme
The PLATINUM China post-SFDA approval clinical trial is comparing the Promus Element stent to the Taxus Liberte paclitaxel-eluting coronary stent (Boston Scientific) in the treatment of patients with a single de novo atherosclerotic lesion. It is a prospective, randomised trial that will enrol 500 patients at 15 sites in China.
In addition, the Promus Element stent is being evaluated in a separate PLATINUM clinical programme, which includes five multicentre 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 Promus Element stent. In April 2011, 12-month results announced from the PLATINUM workhorse randomised, controlled trial demonstrated the clinical non-inferiority of the Promus Element stent in comparison to the Promus stent in treating de novo coronary artery lesions while also showing a procedural benefit of reduced rates of unplanned (bail-out or emergency) stenting.