Svelte™ Medical Systems, Inc. has announced that it has officially received the CE Mark to market its Acrobat  Stent-on-a-Wire (SOAW) Bare Metal Coronary Stent System in the European Union. The Acrobat  SOAW stenting system has been shown in clinical trials to facilitate direct stenting and has the potential to provide substantial procedural time and cost savings. These savings are realized by eliminating the need for a coronary guidewire and balloon dilatation catheters.

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Researchers from Mount Sinai School of Medicine have for the first time developed a way to visualize coronary artery plaques vulnerable to rupture using multi-color computed tomography (CT), an innovation that will lead to better and earlier diagnosis of cardiovascular disease. The data are published in the September issue of Radiology. Ruptures of atherosclerotic plaques are the cause of nearly 70 percent of heart attacks.

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Scientists at Case Western Reserve University and Vanderbilt University found that pulsed light can pace contractions in an avian embryonic heart, with no apparent damage to the tissue. The work, “Optical pacing of the embryonic heart,” was published in the advanced online issue of Nature Photonics. According to the scientists, this non-invasive device may prove an effective tool in understanding how environmental factors that alter an embryo’s heart rate lead to congenital defects.

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Boston Scientific Corporation has announced the start of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of its fourth-generation SYNERGY™ Coronary Stent. The SYNERGY Stent uses a bioabsorbable PLGA polymer and everolimus drug formulation to create a thin, uniform coating confined to the outer surface of the stent. Once the drug has been delivered, the bioabsorbable coating resorbs into the body, leaving behind only a bare-metal stent.

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A study by Canadian physicians reported that the BioSTARTM biodegradable implant achieved comparable closure rates to the Amplatzer Septal OccluderTM (ASO) in children with atrial septal defect (ASD). The BioSTAR device displayed successful outcomes, while avoiding issues associated with implants containing metal. Results of the study, the first to compare the BioSTAR device with the ASO in children, are now available online and in the July print issue of Catheterization and Cardiovascular Interventions.

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Obstructive sleep apnea is a frequent comorbidity in patients suffering from atrial fibrillation, and polysomnography should be used to diagnose it. According to a research presented at SLEEP 2010: Associated Professional Sleep Societies 24th Annual Meeting, portable diagnostic methods underestimate the incidence of obstructive sleep apnea in these patients.
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A paper published in the June issue of IJCP, the International Journal of Clinical Practice, shows that men with ED will often develop coronary symptoms within two to three years of impotence and actually experience a cardiovascular event, such as a heart attack, within three to five years.

The authors stress that it is vital that clinicians stabilize cardiovascular function and control any symptoms before even considering initiating any ED therapy.

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A new algorithm can now detect atrial fibrillation with a 95 accuracy. This is a huge improvement over previous methods. Atrial fibrillation, which affects about three million Americans, is an independent risk factor for death and a major cause of ischemic stroke, in which blood flow is reduced to part of the brain. Atrial Fibrillation can be treated, but it is notoriously difficult to detect. The new algorithm was developed by Ki H. Chon, PhD, head of the Department of Biomedical Engineering at Worcester Polytechnic Institute (WPI), in partnership with Snehraj Merchant of The ScottCare Corporation.

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Abbott announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its XIENCE V (R) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. Japan is the second largest drug eluting stent market in the world after the United States, with approximately 200,000 stent procedures performed each year. The company plans to launch XIENCE V in Japan in the upcoming weeks, immediately following final reimbursement authorization.

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HeartWare International Inc. took another step in its chase after one-time suitor and main competitor Thoratec Corp. filing for an investigational device exemption from the Food & Drug Administration for clearance to use its miniature heart pump in patients with end-stage heart failure who aren’t eligible for a heart transplant. The Framingham, Mass.-based device maker’s left ventricular assist device is already cleared for use as a bridge to heart transplant.

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