January 12, 2017 — Bayer Healthcare has initiated a recall of all its Medrad Intego PET Infusion System Source Administration Sets used in nuclear imaging. The company said particulates can form inside the vials. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. The FDA said use of these devices may cause serious injuries or death.

The company is recalling all product distributed between Oct. 9, 2008 to Oct. 11, 2016. This includes 86,172 products in the U.S. 

According to a recent study by the Harvey L. Neiman Health Policy Institute, the last two decades have seen a substantial decline in new enteral access procedures in the Medicare population. The study, published online in November in the Journal of Vascular and Interventional Radiology (JVIR), also found that maintenance services have increased, with radiologists and emergency physicians surpassing gastroenterologists and surgeons as the leading providers of those procedures.

January 11, 2017 — Lombard Medical Inc. recently announced approval from the Japanese Ministry of Health, Labour and Welfare for its IntelliFlex Low Profile (LP) Delivery System for the Aorfix Endovascular Stent Graft. Commercial launch will follow reimbursement approval, which is anticipated in February 2017.

For patients with atrial fibrillation, the most common form of heart arrhythmia, a main goal of treatment is stroke prevention. As a result, most Afib patients are prescribed a blood thinner such as warfarin, also known by the brand name Coumadin, to combat the potential for blood clots that could lead to stroke. But warfarin is tough to manage, and some patients have trouble adhering to any medication. A new research letter published in JAMA Cardiology finds Afib patients are even more likely to discontinue warfarin therapy if they’ve had a recent procedure done to address their arrhythmia.

January 11, 2017 — Avinger Inc. recently announced the U.S. launch of an enhanced version of the company’s Lightbox imaging console. The Lightbox provides a dual display of images to physicians using Avinger’s Lumivascular system, the first-ever image-guided atherectomy and chronic total occlusion (CTO) recanalization devices for the treatment of peripheral artery disease (PAD), providing physicians with a view inside diseased arteries.

BioVentrix Inc. announced in December the first closed-chest Revivent TC TransCatheter Ventricular Enhancement System procedure in Germany since receiving CE mark certification. The Less Invasive Ventricular Enhancement (LIVE) procedure was performed by interventional cardiologists Christian Frerker, M.D. and Tobias Schmidt, M.D., and by cardiothoracic surgeon Ralf Bader, M.D., at Asklepios Klinik St. Georg in Hamburg, Germany.  The St. Georg Heart team is led by Prof. Dr. Karl-Heinz Kuck, who is also the chairman of the Department of Cardiology and Electrophysiology.

Medinol announced in December positive twelve-month clinical results from the BIONICS study. The study was conducted to evaluate EluNIR, Medinol's novel coronary stent system and the first ever elastomer-coated drug eluting stent (eDES), according to the company.

Ischemic heart failure from previous heart attacks and coronary artery disease is the leading cause of death in the world, affecting more than 12 percent of the world’s population, according to the World Health Organization. Stem cell therapy has been conducted to try to repair heart damage from ischemic heart failure, but in previous studies, the two types of stem cells (autologous bone marrow derived mesenchymal  cells [MSCs] and endomyocardial biopsy derived c-kit+ Cardiac Stem Cells [CSCs]) have been used in separate trials. In a first-in-the-world study, the Minneapolis Heart Institute Foundation (MHIF) is about to begin the CONCERT study, led by Principal Investigator Jay Traverse, M.D. The study will use MSCs and CSCs together to learn if the combination would be more successful than using either alone based on pre-clinical studies in swine demonstrating an enhanced synergistic effect of the combination.

January 10, 2017 — Teleflex Inc. announced that its Arrow VPS Rhythm Device with optional TipTracker technology has been issued U.S. Food and Drug Administration (FDA) 510(k) clearance to commercialize the device in the United States.

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