Boston Scientific Corporation (NYSE: BSX) today announced the beginning of patient enrollment in the PLATINUM China clinical trial, which is designed to evaluate the safety and effectiveness of the Company's PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent compared to the TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent in the treatment of patients with a single de novo atherosclerotic lesion. PLATINUM China is a prospective, randomized trial that will enroll 500 patients at 15 sites in China. Clinical data from the trial will be used to support approval of the PROMUS Element Stent by the State Food and Drug Administration of the People's Republic of China.
The first patient was enrolled in the PLATINUM China trial this week at Shenyang Northern Hospital by Yaling Han, M.D., the Co-Principal Investigator of the trial. The Principal Investigator is Runlin Gao, M.D., of the Cardiovascular Institute and Fu Wai Hospital in Beijing.
"I am enthusiastic about the start of enrollment in the PLATINUM China trial and for the potential of this advanced stent platform as a treatment option for my patients with coronary artery disease," said Dr. Gao. "The new alloy and stent design of the PROMUS Element Stent promise to offer improved deliverability and visibility, even in patients with complex and challenging anatomy."
The PROMUS Element Stent features a novel platinum chromium alloy and innovative stent design, which combine to offer greater radial strength and flexibility while reducing stent recoil. The stent geometry helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density platinum chromium alloy provides superior visibility while permitting thinner struts compared to prior-generation stents.
"PLATINUM China represents the Company's first major coronary drug-eluting stent trial with enrollment exclusive to China," said Keith D. Dawkins, M.D., Senior Vice President and Chief Medical Officer, Cardiology, Rhythm and Vascular Group for Boston Scientific. "The Element Stent series has been well received by physicians in CE Mark countries, and we look forward to bringing this advanced coronary stenting technology to Chinese physicians and their patients."
The Company received CE Mark approval for the PROMUS Element Everolimus-Eluting Stent System in October 2009 and for the TAXUS® Element™ Paclitaxel-Eluting Stent System in May 2010. Both Element systems incorporate the same platinum chromium alloy, innovative stent design and advanced catheter delivery system.
"We are excited to begin evaluating the PROMUS Element Stent in China," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. "The advanced platinum chromium alloy and new balloon catheter offered in the Element Stent System represent significant improvements over prior-generation stents. We are confident that the next-generation Element platform will further extend our global drug-eluting stent leadership."
In the U.S., the Company expects Food and Drug Administration approval for the TAXUS Element Stent System in mid 2011 and for the PROMUS Element Stent System in mid 2012. In Japan, the Company expects approval for the TAXUS Element Stent System in late 2011 or early 2012 and for the PROMUS Element Stent System in mid 2012.
In the U.S., the PROMUS Element Stent System and the TAXUS Element Stent System are investigational devices and are limited by applicable law to investigational use only and are not available for sale.
AI-powered ECG model predicts heart disease risk with precision