St. Jude Medical gained CE mark approval of its Ilumien Optis percutaneous coronary intervention (PCI) optimization system to better visualize stent planning and navigation. The system integrates both fractional flow reserve (FFR) technology to measure pressure inside the coronary arteries and intravascular optical coherence tomography (OCT) imaging technology, in one system.

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.

Elixer bioresorbable stent
Elixer bioresorbable stent

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.

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.

bioresorbable stent, zinc stent
bioresorbable stent, zinc stent

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.

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.

 

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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