The FDA has granted approval to Cook Inc. for its new 36mm Zenith FLEX AAA Endovascular Graft for the treatment of abdominal aortic aneurysms (AAA), according to Cook press release. The state-of-the-art aortic endograft is designed to provide an effective, minimally invasive treatment option for patients with large abdominal aortic neck diameters who previously may not have been candidates for endovascular aortic repair (EVAR).

A subset analysis of diabetic patients in the SPIRIT II Clinical trial of the XIENCE V Everolimus Eluting Stent System showed nearly identical rates of in-stent late loss at six months in diabetic patients as those observed in the overall study patient population, according to new results presented at TCT last week.

Abbott also presented new positive nine-month safety data from the SPIRIT II trial, which showed no additional occurrences of MACE (Major Adverse Cardiac Event) or stent thrombosis between six and nine months.

British researchers have concluded that counseling and education aimed at preventing coronary heart disease have no impact on mortality and little effect in terms of clinical events, reports “heartwire.” Dr Shah Ebrahim (London School of Tropical Medicine, UK) and colleagues report their findings in the Oct. 18, 2006 Cochrane Database of Systematic Reviews.

Cardium Therapeutics and its subsidiary InnerCool Therapies reported on preclinical data demonstrating a new and expanded benefit of early rapid cooling for the potential treatment of acute myocardial infarction (heart attack), as presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2006 Annual Meeting in Washington, DC. The companies also announced their plans for a new clinical study to further assess the safety and potential usefulness of early cooling for heart attack patients, which is expected to be co-sponsored in Sweden and to begin within the next several months.

Early clinical results from Abbott's ongoing ABSORB clinical trial, the world's first study to evaluate the safety and performance of a fully bioabsorbable drug-eluting stent platform for the treatment of coronary artery disease in humans, were presented during the 18th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.

A stent designed to dissolve after it completes its task of propping open narrowed heart arteries is being tested by scientists.

The first human experiment with the dissolving stent is being conducted with 26 patients at hospitals in New Zealand and Europe, the Associated Press reported. The study is designed to test whether the stent is safe enough to be used in larger studies.

GlaxoSmithKline and Flamel Technologies announced FDA approval of once-a-day Coreg CR (carvedilol phosphate) extended-release capsules for the treatment of high blood pressure; a heart attack that has reduced how well the heart pumps (known medically as post-myocardial infarction left ventricular dysfunction); and mild to severe heart failure.

ev3 Inc. has announced a worldwide fracture-free guarantee in support of its new EverFlex family of stents. In the event that an EverFlex stent should fracture within two years of implantation, ev3 will provide a free replacement product to the medical facility, subject to the terms and conditions of the program.

The guarantee was announced today at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.

Boston Scientific Corporation announced that an independent meta-analysis of more than 3,500 patients from five clinical trials, conducted by the Cardiovascular Research Foundation, confirmed the Company's own analysis that the TAXUS paclitaxel-eluting coronary stent is safe and effective. The new analysis was presented by Gregg W.

Radiofrequency ablation is more effective than treatment with amiodarone for the prevention of atrial flutter recurrence in patients who experienced a first symptomatic episode, according to the results of a new study. In addition to the superiority of ablation over amiodarone, there was no increased risk of atrial fibrillation, even in this cohort of older patients, report investigators.

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