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May 26, 2010 – The first angioplasty balloon catheter to integrate intravascular ultrasound (IVUS) imaging has gained CE-mark clearance in Europe. Volcano Corp. also announced today it completed its first clinical cases with the Vibe RX catheter in New Zealand.

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May 26, 2010 – In the constantly evolving battle for the best coronary stent, Boston Scientific said today it initiated the PLATINUM PLUS clinical trial, comparing its next-generation Promus Element everolimus-eluting coronary stent to the Xience Prime everolimus-eluting coronary stent.

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May 26, 2010 – The 12-month study results for a drug-eluting stent that uses hundreds of tiny holes, filled with bioresorbable drug polymer to reduce tissue/polymer contact, demonstrated excellent safety and efficacy outcomes. The results from the NEVO RES-I clinical trial were presented yesterday at EuroPCR in Paris.

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May 25, 2010 – A balloon catheter technology with enhanced trackability and a redesigned tip for greater flexibility was recently cleared by the U.S. Food and Drug Administration (FDA) and received European CE mark.

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May 25, 2010 – A clinical trial will examine benefits of fractional flow reserve (FFR)-guided stenting with optimal medical treatment compared to medical treatment alone. The FAME II clinical trial, the follow-up to the landmark FAME trial, recently started enrolling patients.

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May 25, 2010 – The highly anticipated first results of the RESOLUTE All Comers study were presented today during the late-breaking clinical trial session of the 2010 EuroPCR meeting in Paris. In the 2,292-patient randomized trial, Medtronic’s Resolute zotarolimus-eluting stent was found to be as safe and effective as Abbott’s Xience V everolimus-eluting stent.

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May 25, 2010 – The first patient has been implanted with a bare metal coronary stent mounted on a drug-eluting balloon in the European Pioneer trial, which began this week.

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May 25, 2010 – A self-expanding, drug-eluting stent (DES) that just gained CE mark clearance in Europe is designed to ensure optimal apposition in the initial hours and days after an acute myocardial infarction (AMI) procedure.

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May 24, 2010 - Utilizing the iso-osmolar agent Visipaque (iodixanol) could save hospitals $54,617 per 100 patients when compared to the low osmolar nonionic agent iopamidol. This was according to results from a study presented at the American Heart Association’s Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke Scientific Sessions in Washington, D.C., held May 19-21.

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May 24, 2010 – New intravascular imaging innovations, such as registered angiography and intravascular ultrasound (IVUS), forward-looking IVUS and a combined IVUS/balloon catheter will be highlighted May 25-28 at EuroPCR in Paris. Volcano Corp. will spotlight new product launches and its works in progress at the conference. The new product introductions include:

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May 24, 2010 – The U.S. Justice Department settled a pay-to-play scheme at The Christ Hospital last week for $108 million. The hospital only allowed access to its Heart Station outpatient cardiology testing and noninvasive heart procedure unit to cardiologists who referred cardiac business to the hospital.

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Technology

May 24, 2010 – New collaborations will enable the use of Boston Scientific’s iLab Ultrasound Imaging System with the Philips’ Allura Xper and the Siemens’ Axiom Artis and Artis zee interventional X-ray systems. The iLab provides both intravascular ultrasound (IVUS) and intracardiac ultrasound (ICE).

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May 21, 2010 – A second company is hoping to gain U.S. Food and Drug Administration (FDA) clearance for an optical coherence tomography (OCT) intravascular imaging system. Volcano Corp. said its second generation OCT system is pending FDA investigational device exemption (IDE) approval so it can start its VOILA clinical trial in the United States and South America.

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May 21, 2010 – The first successful transcatheter mitral valve implantation (TMVI) for a new mitral valve technology will be highlighted at the EuroPCR 2010 scientific meeting in Paris. A proprietary transcatheter delivery system was used to successfully deliver the valve in the porcine model.

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May 21, 2010 – Results of an in vivo study of 48 porcine arteries implanted with a biodegradable stent showed biodegradation is measurable and begins at the first day of implant. However, high radial strength is maintained during biodegradation.

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