Technology

Positron Corp. announced the release of the PosiRx 3000-Series, its latest pharmacy automation systems. The PosiRx 3000-Series are the first systems to automate and encompass the complete compounding process, from generator elution to dose distribution, of multiple diagnostic SPECT agents in an environment engineered to be ISO Class 5 and USP 797 compliant. Designed for facilities dispensing as many as 300 patient-specific doses per day, the PosiRx 3000-Series will benefit providers and patients by enabling unit dose radiopharmaceuticals to be prepared more cost effectively and accurately than previously possible.

Home May 16, 2013
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Elixer bioresorbable stent
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Elixir Medical Corp. announced it received CE (Conformité Européenne) mark approval for its DESolve Novolimus-eluting bioresorbable coronary stent scaffold system. The scaffold is designed to degrade in about one year returning the patients’ coronary vessel ultimately to its normal de novo state.

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Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved Liptruzet (ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. Liptruzet (pronounced LIP-true-zett) contains ezetimibe, an efficacious LDL cholesterol lowering therapy, and atorvastatin, currently one of the most widely prescribed statins in the United States. Once-daily Liptruzet treats two sources of cholesterol by inhibiting both the absorption of cholesterol in the digestive tract — through ezetimibe — and the production of cholesterol in the liver — through atorvastatin.

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bioresorbable stent, zinc stent
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University of Michigan researchers said the preliminary results of using biresorbable zinc stents were amazing, with corrosion rates exactly where they need to be for a stent successful platform.

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Boston Scientific Corporation completed a first-in-human clinical trial utilizing the IntellaTip MiFi XP Ablation Catheter for the treatment of type 1 atrial flutter, an arrhythmia originating in the right atrium of the heart that affects nearly 1 million people in the United States. This single center feasibility trial enrolled 10 patients and was led by Prash Sanders, MBBS, Ph.D., FHRS, director of the Centre for Heart Rhythm Disorders at the University of Adelaide and the Royal Adelaide Hospital in Australia.

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Sorin Group has received U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application and clinical trial protocol to begin evaluating its Perceval S sutureless aortic tissue valve.

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St. Jude Medical Inc. has received CE Mark approval of its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new portfolio is designed to lower the risk for lead abrasion and to ensure high-voltage therapy delivery.

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Vascular Solutions Inc. announced that it has re-launched the Venture catheter, a deflectable-tip catheter used to provide guidewire directional control in challenging coronary and peripheral interventional procedures. The device is available immediately in the United States and expected to become available in select international markets over the next few months.

Home May 15, 2013
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The Spectranetics Corporation announced the U.S. Food and Drug Administration's (FDA) approval of its adjunct analysis plan associated with the EXCITE ISR clinical trial, studying the treatment of in-stent restenosis (ISR) in the legs. The goal of the adjunct analysis plan is to demonstrate statistically significant clinical superiority of laser atherectomy plus balloon angioplasty (PTA) compared with PTA alone, prior to full enrollment of the EXCITE ISR study.

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ScottCare unveiled new advances for importing, monitoring and reviewing cardiac implantable electronic device (CIED) data at this year’s Heart Rhythm Society’s scientific session last week.

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New study data released at the Heart Rhythm Society (HRS) meeting last week validates the importance of contact force technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias. Unveiled in HRS abstracts, the data also demonstrated the ability of the Endosense TactiCath ablation catheter to detect excessive contact force during robotic catheter navigation.

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Heart IT has released its WebPaxUniversal Viewer as an addition to its product portfolio. The new system allows hospitals and clinics to add Web-based, fully diagnostic image viewing to their existing infrastructure for both radiology as well as complex moving cardiology images. The WebPax Universal Viewer offers the same Web-based, zero-footprint image viewing technology that was first developed and patented by Heart Imaging Technologies.

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nContact Inc. said it received conditional approval for an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin enrollment in the CONVERGE trial, a multicenter, prospective, randomized study evaluating patients with symptomatic persistent atrial fibrillation (AF). AF is the most common cardiac arrhythmia, a condition that disrupts the ability of the atria (upper chambers of the heart) to beat regularly and pump blood efficiently. The CONVERGE study, designed to investigate the epicardial/endocardial Convergent Procedure, combines the cardiac ablation expertise, techniques, and technologies of both electrophysiologists and cardiothoracic surgeons.

Home May 14, 2013
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Biosense Webster Inc. announced the 12-month safety and effectiveness results of the Thermocool Smarttouch catheter and software module in the treatment of symptomatic, drug refractory, paroxysmal atrial fibrillation (AF) from the SMART-AF investigational device exemption (IDE) clinical trial. The results were presented at the Heart Rhythm Society’s 34th Annual Scientific Sessions by Andrea Natale, M.D., a member of the study advisory committee and executive medical director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas.

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CardioPET
Feature | Thijs Spoor

The next generation of positron emission tomography (PET) imaging agents will herald an age when PET will eclipse single photon emission computed tomography (SPECT) as the “go to” modality for molecular imaging. It will do so by enabling personalized medicine through precision diagnostics, the ability to be delivered cost-effectively in a manner with less radiation to patients, by leveraging hardware advances already being commercialized, and by taking advantage of the extra throughput capacity present in the U.S. installed base of PET/CT scanners.

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