The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective Oct. 1, 2012. To assist the...
September 24, 2012 — Bio DG announced that its patent for a novel metal system, to use as biodegradable material in developing implantable medical devices, was granted by the U.S. Patent Office on...
September 21, 2012 — Endologix Inc. announced this month it received CE mark for the current version of the Nellix EndoVascular Aneurysm Sealing System for the...
September 21, 2012 — Cardionovum GmbH announced that the results of a preclinical study and a first-in-man clinical study of its Primus drug-coated balloon (DCB) will be published in the October...
September 20, 2012 — Boston Scientific Corp. has signed a definitive agreement to acquire BridgePoint Medical Inc., a privately held company based in Minneapolis. BridgePoint Medical has developed...
September 19, 2012 — In response to criticism by physicians about the restrictiveness of conditions put forth by the Center for Medicare and Medicaid Services (CMS) for reimbursement for...
September 18, 2012 — Inpatient hospital treatment accounts for the largest proportion of healthcare spending in the United States, with the use of diagnostic imaging services such as magnetic...
September 18, 2012 — Neovasc Inc. announced that acute results from preclinical studies of its Tiara valve for the transcatheter treatment of mitral regurgitation were published in the ...
Covidien announced the launch of the Viance Crossing Catheter and Enteer Re-entry System for treating chronic total occlusions (CTOs) endovascularly. The devices are now available in the United...
September 18, 2012 — Abiomed Inc. announced it received confirmation from the American Medical Association (AMA) of three new Category I Current Procedure Terminology (CPT) codes for Impella...
September 17, 2012 — The American College of Cardiology (ACC) has released the results of its 2012 Practice Census, showing that the number of physician-owned practices continues to decline,...
Cardiologists are restricting the use of transcatheter aortic valve implantation (TAVI) to very old or very sick patients at high surgical risk, according to research presented at the European...
The Cardiovascular Research Foundation (CRF) announced the late-breaking trials and first report investigations that will be presented at next month's...
Barco announced the launch of its MDSC-2226, a 26-inch surgical display providing full compatibility with Barco’s networked digital operating room. Featuring an integrated IP-to-AV decoder, an...
September 14, 2012 — Coronary revascularization appropriate use criteria (AUC) are now just a click away with the new SCAI Quality Improvement Toolkit (SCAI-QIT) AUC and Guidelines App, launched...
CircuLite Inc. announced that it has received CE marking approval for the Synergy Circulatory Support System, a micro-pump designed to halt the progression of heart failure. By working with the...
Abiomed Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new percutaneous, catheter-based Impella ventricular assist device (VAD) providing...
September 10, 2012 — In a recent clinical trial, the Solitaire Flow Restoration Device dramatically outperformed the standard mechanical treatment. Findings from the trial, called SOLITAIRE With...
September 6, 2012 — Daiichi Sankyo Co. Ltd. and Eli Lilly and Co. announced data from the TRILOGY ACS study, a phase III trial comparing prasugrel plus aspirin to clopidogrel plus aspirin in...
Medtronic has reached two clinical program milestones for its CoreValve system in the United States. It completed enrollment in its study of high-risk patients in its CoreValve U.S. Pivotal...
September 4, 2012 — Philips Heathcare announced that mVisum Inc.’s STEMI Alert smartphone app is now available to work in conjunction with Philips TraceMasterVue and IntelliSpace...
The great Japanese earthquake and consequent tsunami of March 11, 2011, which hit the northeast coast of Japan with a magnitude of 9.0 on the Richter scale, was one of the largest ocean-trench...
August 30, 2012 — Aspirin combined with the antiplatelet drug clopidogrel is no better than aspirin alone for stroke prevention in people with a history of lacunar strokes, and the combination...
August 30, 2012 — According to Millennium Research Group (MRG), an authority on the medical technology market, as significant numbers of peripheral vascular and vascular access procedures move out...
Vascular closure devices that use an active method to immediately seal the femoral access site can enable faster patient ambulation, reduce nursing time and speed discharge. However, one of...
Cardiac computed tomography (CT), magnetic resonance imaging (MRI), echocardiography and nuclear myocardial perfusion imaging each offer advantages and disadvantages, and frequently at least two...
Recently, concerns have been raised that transradial (TR) cardiac catheterization significantly increases radiation exposure when compared with the conventional...
The standard-of-care for dual antiplatelet therapy (DAPT) for more than a decade has been clopidogrel (Plavix) plus aspirin. This standard is now being challenged by new agents —...
August 28, 2012 — The International Contrast Ultrasound Society (ICUS) applauded the U.S. Food and Drug Administration’s (FDA) decision to modify the U.S. product label for several ultrasound...
August 28, 2012 — GE Healthcare announced important changes to the U.S. product label for Optison (perflutren protein-type A microspheres injectable suspension, USP), a...
The recent U.S. Supreme Court ruling upholding the 2010 Affordable Care Act (ACA) may have significant impact on healthcare providers and their cardiovascular departments. While the ruling will...
August 23, 2012 — Decision Resources, a research and advisory firm for pharmaceutical and healthcare issues, finds that the 12-month post-hospital acute coronary syndrome market will initially...
Philips Healthcare and Corindus Vascular Robotics announced a distribution agreement for Corindus’ CorPath 200 System. The system was recently cleared by the U.S. Food and Drug...
August 22, 2012 — Authors of an article in the Journal of Endovascular Therapy have evaluated the effectiveness of endovascular brachytherapy using liquid beta-emitting rhenium-...
Comedian Rosie O'Donnell’s heart attack last week is helping increase public education about how women’s myocardial infarction (MI) symptoms differ from men's. She posted a blog on Monday...
August 17, 2012 — Jarvik Heart Inc., a privately held company that develops and manufactures cardiac assist devices, announced U.S. Food and Drug Administration (FDA) approval of its pivotal trial...
August 15, 2012 — Previously unreleased three-year data from the Zilver PTX randomized controlled trial of paclitaxel-eluting stents for femoropopliteal disease indicate that Cook Medical’s...
Due to the increasing number of transcatheter aortic valve replacements (TAVR) and endovascular aneurysm repair (EVAR), a new startup company has developed a transfemoral combined access and...
August 14, 2012 — Berlin Heart announced that a study recently published in the New England Journal of Medicine (NEJM) concluded that survival using the Excor pediatric...
August 14, 2012 — The U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance to Stryker Neurovascular’s Trevo Pro Retriever, indicated for the removal of blood...
August 9, 2012 — The U.S. Food and Drug Administration (FDA) is informing healthcare providers and patients that the indications for use and labeling for the Stryker Wingspan...
Aug. 8, 2012 — The U.S. Food and Drug Administration (FDA) approved the Abbott’s Omnilink Elite Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease. This...
Aug. 8, 2012 — Vascular Solutions Inc. launched the SuperCross FT, a new flexible-tip version of its line of SuperCross microcatheters. It is designed to address the majority of complex...
Aug. 8, 2012 — The Berlin Heart Group said the U.S. Food and Drug Administration (FDA) has granted approval for its post approval study, a condition of the humanitarian device...
August 3, 2012 — GE Healthcare announced it has already received six orders for its Discovery IGS 730 system since receiving U.S. Food and Drug Administration (FDA) clearance in February 2012.
Interventional procedures are growing rapidly and becoming more specialized in diverse areas of care. In the next decade, the number of people living in the United States who have heart...
Trends and new technology for cardiac computed tomography angiography (CCTA) were highlighted during the 2012 Society of Cardiovascular CT (SCCT) annual scientific meeting in July in Baltimore, Md...
Percutaneous coronary interventional (PCI) procedures are performed throughout hundreds of US institutions every day. With the increasing frequency of these...
July 27, 2012 — Cook Medical announced general availability of the Aprima Access nonvascular introducer set, the first product in the Aprima drainage portfolio. It is a nonvascular access set used...
July 27, 2012 — C. R. Bard Inc. announced that its Lutonix technology center has completed patient enrollment into its global, multicenter LEVANT 2 randomized clinical trial.
The current Medicare payment system is irreparably flawed and a new, more permanent solution must be reached, American College of Cardiology (ACC) President...
A study using CT perfusion imaging showed patients presenting with ischemic stroke may be successfully treated with endovascular or minimally invasive therapy well beyond ...
July 26, 2012 — Any exposure to radiation, no matter how small, has the potential of leading to future health issues, including many types of cancer, medical experts agree. Doing...
July 26, 2012 — Angion Biomedica Corp. announced that the first patient was dosed in a Phase II multicenter clinical trial evaluating BB3 for the treatment of heart attack (acute myocardial...
July 23, 2012 — Medtronic Inc. announced the first patient enrollment in a clinical trial comparing the CoreValve system with surgical aortic valve replacement in patients with severe aortic...
July 20, 2012 — Ticagrelor, a blood-thinning drug approved by the U.S. Food and Drug Administration (FDA) in 2011, should be considered along with older blood thinners clopidogrel and prasugrel...
July 20, 2012 — The ability to see inside the arteries of vascular disease patients in high resolution before and during stenting procedures can offer valuable information. A new study of...
July 20, 2012 —Acusphere Inc. announced that it had completed the marketing authorization application (MAA) dossier for its lead product candidate, Imagify (perflubutane polymer microspheres) for...
