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May 4, 2012 - SMT Research & Development Ltd. (SMT) announced the addition of three key executives to its management team, including a new CEO, CFO and chief medical officer, plus two additions to its board of directors. The company also announced that its shareholders and board of directors have approved the company's name change to Keystone Heart Ltd.

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May 4, 2012 - The U.S. Food and Drug Administration (FDA) has approved the premarket approval application (PMA) for the Medinol Ltd. Presillion plus cobalt chromium (CoCr) coronary stent on a rapid exchange delivery system. This device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease associated with stenotic lesions in de novo native coronary arteries (length < 30 mm) with a reference vessel diameter of 2.5 to 4 mm.

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May 4, 2012 - Medtronic Inc. announced six-month pooled outcomes from randomized and crossover patients in the Symplicity HTN-2 clinical trial following renal denervation with the Symplicity renal denervation system showing significant, sustained blood pressure reduction in patients with treatment-resistant hypertension. These data presented at the European Society of Hypertension annual meeting showed patients (n=84) who received renal denervation treatment with Symplicity experienced a mean blood pressure reduction of -28/-10 mm Hg (p<0.001) at six months following treatment compared with baseline. No evidence of renal impairment was observed and renal function measures remained unchanged.

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May 2, 2012 — The Spectranetics Corp. announced U.S. Food and Drug Administration (FDA) approval of the new advanced GlideLight Laser Sheath for removal of cardiac leads.

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May 2, 2012 — St. Jude Medical Inc. yesterday released its biannual product performance report (PPR) on its website, updating the performance of all the company’s cardiac rhythm management devices, including actively-monitored registry data that supports the safety and reliability of the current-generation Durata lead with Optim insulation. The report also provides a new, expanded analysis specifically addressing the performance of the company’s high-voltage leads.

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May 2, 2012 — Vessix Vascular Inc. announced this week that it has received CE mark approval for its V2 Renal Denervation System for the treatment of hypertension. Renal denervation is a percutaneous catheter-based therapy that uses RF energy to disrupt renal sympathetic nerves whose hyperactivity leads to uncontrolled high blood pressure.

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Feature

May 1, 2012 – The Centers for Medicare and Medicaid Services (CMS) announced today it will now cover transcatheter aortic valve replacement (TAVR) for Medicare patients under certain conditions. The coverage decision announced by CMS Acting Administrator Marilyn Tavenner offers important new technology to some of Medicare’s sickest patients.

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May 1, 2012 — Theragenics Corp. announced that Galt Medical, a wholly-owned subsidiary of Theragenics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Galt VTI valved tearaway introducer.

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May 1, 2012 — Cameron Health Inc. announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel voted 7-1 that sufficient data exists demonstrating the efficacy and safety of the S-ICD (subcutaneous-implantable cardioverter defibrillator) system for the treatment of sudden cardiac arrest (SCA).

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May 1, 2012 - The use of a dedicated pediatric imaging department, with dedicated pediatric computed tomography (CT) technologists, for pediatric CT scans significantly reduces the radiation dose delivered to the patient, according to a study in the May issue of the Journal of the American College of Radiology.

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Videos | ACC

One of the most interesting educational exhibits at the recent American College of Cardiology (ACC) 2012 Scientific ...

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April 27, 2012 — Amidst growing concerns over healthcare costs, the Society of Nuclear Medicine (SNM) is offering a solution to help cut back on federal spending in its new report, “Imaging with CARE.” According to the report, an estimated $1.32 billion could be saved on nuclear and molecular imaging procedures over the next 10 years by taking steps to reduce the number of repeated scans due to poor quality images.

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Technology

April 27, 2012 – Toshiba America Medical Systems Inc. announced the FDA clearance of Adaptive Iterative Dose Reduction 3D (AIDR 3D), the company’s newest dose-reduction technology. Toshiba will offer the AIDR 3D software upgrade and related training, complimentary, to all existing Aquilion ONE, Aquilion Premium and Aquilion PRIME CT customers.

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April 27, 2012 - More than 150 molecular imaging professionals gathered last week at the Society of Nuclear Medicine’s third Multimodality Cardiovascular Molecular Imaging Symposium held at the National Institutes of Health. The two and a half day symposium brought together individuals from multiple scientific disciplines—including chemistry, engineering, physics, molecular biology, cardiovascular physiology and imaging sciences—with the goal of promoting the emerging field of cardiovascular molecular imaging.

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April 26, 2012 — Interventional cardiologists can and should lead efforts to improve quality, cut costs and ensure appropriate use of procedures. Elliott Fisher, M.D., MPH, professor of medicine at Dartmouth, an internationally recognized expert on variations in health system performance and one of the originators of the concept of accountable care organizations, will challenge the interventional cardiology community to accomplish these and other goals at a town hall meeting during the 2012 Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI) in Las Vegas. His keynote address, “Why Interventional Cardiology Needs to be a Change Leader,” will set the stage for an interactive discussion with cardiologists attending the conference.

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