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European DES Market Gains New Offerings From Boston Scientific, Abbott

This article was originally published in The Gray Sheet

Executive Summary

Competition is heating up in the European drug-eluting stent space, as Boston Scientific launches its third-generation Promus Element stent and Abbott offers expanded indications for Xience V and Xience Prime for diabetes patients

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Research In Brief

Boston Scientific PLATINUM program: Company said March 16 it has completed enrollment of the pivotal, randomized, controlled trials of its Promus Element everolimus-eluting stent in small vessels and long lesions. The studies compare Promus Element to historical controls of patients treated with Boston Scientific's Taxus Express2 paclitaxel-eluting stent. The small-vessel trial includes 94 patients with de novo lesions from 2.25 mm to less than 2.50 mm in diameter and up to 28 mm in length; the long-lesion trial enrolled 102 patients with de novo lesions from 24 mm to 34 mm in length and from 2.50 mm to 4.25 mm in diameter. Promus Element received CE-mark approval last fall (1"The Gray Sheet" Nov. 9, 2009). Results of the PLATINUM Workhorse trial comparing Promus Element to Promus, which will be used to support U.S. FDA approval, are expected in early 2011. The firm revealed results of the PERSEUS trial of its platinum-chromium Taxus Element stent at the American College of Cardiology meeting in Atlanta

Research In Brief

Boston Scientific PLATINUM program: Company said March 16 it has completed enrollment of the pivotal, randomized, controlled trials of its Promus Element everolimus-eluting stent in small vessels and long lesions. The studies compare Promus Element to historical controls of patients treated with Boston Scientific's Taxus Express2 paclitaxel-eluting stent. The small-vessel trial includes 94 patients with de novo lesions from 2.25 mm to less than 2.50 mm in diameter and up to 28 mm in length; the long-lesion trial enrolled 102 patients with de novo lesions from 24 mm to 34 mm in length and from 2.50 mm to 4.25 mm in diameter. Promus Element received CE-mark approval last fall (1"The Gray Sheet" Nov. 9, 2009). Results of the PLATINUM Workhorse trial comparing Promus Element to Promus, which will be used to support U.S. FDA approval, are expected in early 2011. The firm revealed results of the PERSEUS trial of its platinum-chromium Taxus Element stent at the American College of Cardiology meeting in Atlanta

Research In Brief

Medifocus: Vancouver company files a response to FDA's questions on its investigation device exemption application for a pivotal trial of its Microfocus APA 1000 system for the treatment of breast cancer. The application was submitted in Jun,e and FDA's letter was received July 13. The 238-patient pivotal clinical trial will assess the safety and efficacy of focused microwave heat energy delivered by the Microfocus APA 1000 in combination with neo-adjuvant chemotherapy on large breast cancer tumors as measured by tumor shrinkage. A Phase II multicenter randomized study of Microfocus APA 1000 showed that the median tumor shrinkage in the thermo-chemo arm was about 88% compared to about 59% for chemotherapy alone. Almost 80% of all breast tumors treated with Microfocus APA 1000 got substantially smaller versus 20% in the chemotherapy group

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