Singapore, March 16, 2010: Boston Scientific Corporation received Australian Therapeutic Goods Administration (TGA) approval for its PROMUS Element and TAXUS Element Stent Systems, the Company's third-generation drug-eluting stent (DES) technology. The Element Stent Systems incorporate a novel platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. The company is now marketing the PROMUS Element and TAXUS Element Stent Systems in Australia.

 

The platinum chromium alloy used in the Element Stent Series is a generation beyond cobalt chromium, and is engineered specifically for coronary stenting. This proprietary alloy, when combined with the innovative Element Stent design, offers greater radial strength and flexibility than older alloys such as cobalt chromium, used in the Xience V and Xience Prime Stents. Platinum chromium (PtCr) also provides superior visibility and minimized recoil compared to studied cobalt chromium stents.

 

"The platinum chromium alloy and new stent design used in the Element Stent System represent significant innovations in drug-eluting stent technology," said Professor Ian Meredith of Monash Medical Centre, Melbourne. "In my experience, the Element platform offers a stenting option that provides enhanced deliverability and visibility with excellent conformability and low recoil. I believe it may offer performance improvements that could simplify procedures and allow treatment of a broader range of patients." Professor Ian Meredith performed the first implant of the PROMUS Element Stent.

 

"We are proud to introduce our third-generation drug-eluting stent to physicians and patients in Australia. The Element Stent Series is the latest example of Boston Scientific's commitment to DES market leadership and continued innovation. It gives physicians the choice of two proven drug and polymer combinations - used in millions of patients worldwide - on an entirely new stent platform. We are confident our Element Stent Series will further extend our global DES leadership," said Mark Wallwork, Managing Director, Boston Scientific Australia.

 

The release noted that the PROMUS Element Everolimus-Eluting Coronary Stent System is used in the PLATINUM clinical trial, which completed enrollment of 1,531 patients in September 2009 at 133 sites worldwide including five in Australia. PLATINUM is a randomized, controlled, pivotal trial designed to support U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the PROMUS Element Stent System.

 

The TAXUS Element Paclitaxel-Eluting Coronary Stent is used in the PERSEUS Clinical Program. The PERSEUS program includes more than 90 clinical sites, including three in Australia, four in New Zealand and one in Singapore. The trial design includes both a randomized, single-blind, non-inferiority workhorse arm (2.75 to 4.00 mm diameter stents), and a small vessel (2.25 and 2.50 mm diameter) superiority trial.

 

The PROMUS Element Stent System received CE Mark approval in October 2009. The company anticipates FDA approval for the PROMUS Element system in 2012. The TAXUS Element Stent System was launched in select international markets in May 2009. CE Mark approval for the TAXUS Element system is expected in the second quarter of 2010, and FDA approval is expected in 2011.

 

In the U.S., the PROMUS Element and TAXUS Element Stent Systems are investigational devices and are limited by applicable law to investigational use only and are not available for sale. In the EEA, the TAXUS Element Stent System is CE mark pending and not available for sale.