Both Element Systems incorporate the same novel platinum chromium (PtCr) alloy, innovative stent design and advanced catheter delivery system, and represent the company’s third-generation drug-eluting stent technology.
India is one of the fastest-growing drug-eluting stent markets in the world, with the number of coronary drug-eluting stents implanted annually estimated at more than 150,000. In 2010, the company received approval from the Drugs Controller General of India to market these systems.
“The new platinum chromium alloy and stent design of the PtCr Element Stent series represent significant innovations in drug-eluting stent technology,” said Ashok Seth, Fortis Escort Heart Institute, New Delhi, India. “I believe the Element platform offers performance improvements that could simplify procedures and allow treatment of a broader range of patients.”
The Promus Element Stent is being evaluated in the PLATINUM clinical trial, which completed enrolment of 1,532 patients in September 2009 at more than 140 sites worldwide. PLATINUM is a randomised, controlled, pivotal trial designed to support the US FDA and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of this stent system. In September 2010, data were presented on 30-day and nine-month clinical outcomes and nine-month quantitative coronary angiography and intravascular ultrasound supporting the safety and efficacy of Promus.
On the other hand, the Taxus Element Stent is being evaluated in the PERSEUS trial, which reported 12-month results in March 2009, demonstrating positive safety and efficacy outcomes in workhorse lesions for the Taxus Element Stent System compared to the Taxus Express2 Stent System. The PERSEUS clinical programme compared the Taxus Element Stent to prior-generation Boston Scientific stents in more than 1,600 patients in two parallel trials at 90 centres worldwide.
The Promus Element Everolimus-Eluting Stent System received CE mark in October 2009 and the Taxus Element Paclitaxel-Eluting Stent System in May 2010.
The Taxus Element Stent will be commercialised in the USA as the Ion Paclitaxel-Eluting Platinum Chromium Coronary Stent System; the Proums Element Stent will be marketed as the Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System. In USA, these systems are limited by applicable law to investigational use only and are not available for sale.
