Boston Scientific has presented clinical endpoint data from a prospective, randomised clinical study of its Promus Element everolimus-eluting platinum chromium (PtCr) coronary stent system, for the treatment of patients with a single de novo atherosclerotic lesion.
Featuring a platinum chromium alloy and new stent design, the Promus Element reduces stent recoil and provides greater radial strength and flexibility.
The higher density platinum chromium alloy also provides superior visibility while permitting thinner struts compared to prior-generation stents, according to the company.
The stent’s geometry helps to create consistent lesion coverage and drug distribution, while the advanced catheter delivery system improves deliverability.
The trial, Platinum China, has enrolled 500 patients from 15 sites in China, and evaluated the safety and effectiveness of the Promus Element stent compared to the Taxus Liberte paclitaxel-eluting coronary stent, which was awarded a CE mark in 2010.
The study demonstrated a low nine-month ARC definite / probable stent thrombosis rate of 0% and a 2.2% nine-month target lesion revascularisation rate, as well as showing the safety and effectiveness of the device.
The data, which was released by the China’s Ministry of Health’s cardiovascular interventional diagnosis and treatment management information network, showed that in 2011 there were more than 330,000 people receiving coronary artery intervention treatment in China.
The company said China’s operation rate in cardiovascular interventional therapy is still relatively low compared to developed countries.
Boston Scientific CEO Michael Mahoney said the company is dedicated to provide various efficient solutions for customers and patients in China.
"Under the leadership of our new management team, our sales in the Chinese market have grown significantly," Mahoney said.
"I believe our China team will become even more integrated within the Chinese market and will focus on localised research and development – building up long-term strategic relationships and providing effective and appealing products to Chinese patients."