News | Population Health

Tens of thousands of people across North Carolina are at high risk of developing cardiovascular disease that had not been identified previously, according to a new study published in Journal of the American Medical Informatics Association. The study team, composed of researchers at the University of North Carolina (UNC) School of Medicine and the UNC Gillings School of Global Public Health, created a statewide network of healthcare professionals in urban, suburban, and rural areas who work in small primary care practices and used existing electronic health records to identify at-risk individuals. Primary care doctors across the state then used this analysis to proactively engage patients to reduce their risk.

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Technology | FFR Technologies

CathWorks announced that its FFRangio System received U.S. Food and Drug Administration (FDA) 510(k) clearance. The FFRangio system demonstrated accuracy versus the invasive fraction flow reserve (FFR) wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish substantial equivalence of the FFRangio system.

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Videos | Structural Heart

John Carroll, M.D., FACC, FSCAI, director of interventional cardiology at the Cardiac and Vascular Center at the ...

Home December 20, 2018
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Videos | Heart Failure

Andreas Brieke, M.D., director of mechanical circulatory support, heart failure physician and site principal ...

Home December 20, 2018
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Technology | Vascular Closure Devices

Cardiva Medical Inc. announced the company has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the Vascade MVP Venous Vascular Closure System. Vascade MVP is the first and only vascular closure system, according to Cardiva, designed and labeled specifically for multi-site venous closure – for 6-12 French inner diameter sheaths. This access site approach and size range is the standard in electrophysiology procedures such as cardiac ablation and left atrial appendage closure.

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News | Stem Cell Therapies

December 20, 2018 — The U.S. Food and Drug Administration (FDA) has warned Genetech Inc. and its president, Edwin N ...

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News | Peripheral Artery Disease (PAD)

A new set of appropriate use criteria (AUC) released Dec. 17 by a group of cardiovascular professional societies provide guidelines for peripheral artery interventions. The purpose of the AUC is to provide guidance to clinicians who may refer patients for revascularization treatments and to interventionalists and surgeons themselves. With the field of peripheral artery disease constantly evolving, it is imperative to offer tools and resources that physicians can utilize to provide the best care for their patients.

Home December 19, 2018
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News | Cardiovascular Business

As part of its plans to spin off its healthcare division into a separate company, GE reportedly submitted the paperwork Dec. 19 for an initial public offering (IPO) of the standalone company. Inside sources familiar with the situation told Bloomberg that the public filing will likely happen in spring 2019. Numerous sources reported that the news caused a significant jump in the parent company’s stock price.

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News | Atrial Fibrillation

Irish medical device company AuriGen Medical won the prestigious Global Innovation Award at the International Conference for Innovations in Cardiovascular Systems (ICI), Dec. 2-4 in Tel Aviv, Israel. AuriGen Medical, which specializes in the treatment of atrial fibrillation, is developing the first heart implant to treat both the stroke and heart failure risk associated with this often fatal condition.The Global Innovation award attracted entries from the best medical device and pharmaceutical start-ups from around the world.

Home December 18, 2018
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News | Catheters

Merit Medical Systems Inc. announced that it has acquired substantially all of the assets of Vascular Insights LLC, based in Quincy, Mass. Vascular Insights’ primary assets are the ClariVein IC and ClariVein OC specialty infusion and occlusion catheter systems, which have been utilized in more than 120,000 cases to treat superficial venous disease, particularly below the knee (BTK), and venous leg ulcers (VLU). The ClariVein systems address a $700 million global market. The ClariVein IC system has 510(k) clearance from the U.S. Food and Drug Administration (FDA), the ClariVein OC system is CE-marked, and the systems are covered by 43 patents issued worldwide.

Home December 18, 2018
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News | Cardiovascular Business

A judge of the Federal District Court for the Northern District of Texas ruled the Affordable Care Act (ACA) unconstitutional in a shocking decision that could impact the health insurance coverage of millions of Americans. A group of Democratic state attorneys general plans to bring the case to the 5th Circuit U.S. Court of Appeals, and the Trump administration said the law will remain in place until the appeal process is complete.

Home December 17, 2018
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News | Antiplatelet and Anticoagulation Therapies

Among otherwise healthy people, a daily dose of aspirin does not save lives and causes additional bleeding, a new analysis has found. The meta-analysis of 11 aspirin therapy clinical trials involving more than 157,000 healthy individuals since the 1980s found the drug does not reduce deaths, heart attacks and strokes. Low-dose aspirin users were also about 50 percent more likely to have major bleeding compared with those who did not use aspirin, the researchers concluded. The findings were published Dec. 17 in the European Heart Journal.

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News | Cath Lab

Shockwave Medical announced a new investment and collaboration agreement with Abiomed Inc. As outlined by the agreement, Abiomed will invest $15 million in Shockwave and the two companies will collaborate on a training and education program in the United States and Germany focused on the benefits of complementary use of their respective technologies.

Home December 14, 2018
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News | Hypertension

Digital health company Analytics 4 Life and Actelion Pharmaceuticals Ltd. announced a collaborative agreement to investigate the use of Analytics 4 Life’s diagnostic imaging technology in pulmonary hypertension. The first 500-person clinical study has been initiated for this serious, life-threatening condition affecting millions of people worldwide.

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News | EP Lab

The Department of Health and Human Services (HHS) recently entered into an interagency agreement with the National Aeronautics and Space Administration (NASA) to coordinate scientific research efforts on healthcare. Eric D. Hargan, deputy HHS secretary, wrote the following column about the implications of the agreement.

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