Abbott announced the launch of the company's TRILUMINATE Pivotal trial evaluating the safety and effectiveness of its TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR). This is the first pivotal Investigational Device Exemption (IDE) trial in the U.S. to evaluate a catheter-based, non-surgical treatment for patients with severe TR – a condition in which the valve does not close properly, allowing blood to flow backward into the heart, which forces the heart to work harder. In severe cases, this condition can potentially lead to heart failure if left untreated.

At the European Society of Cardiology (ESC) Congress 2019 together with the World Congress of Cardiology, the World Heart Federation launched a new “roadmap” aimed at reducing the global burden of CVD in people living with diabetes. The Roadmap on the prevention of cardiovascular disease among people living with diabetes is a key reference document for anyone involved in the planning, organization, implementation and monitoring, and evaluation of approaches related to CVD prevention in people living with diabetes. It outlines a vision of an ideal pathway of care, potential roadblocks along this pathway and proposed solutions, with examples from practice.

September 4, 2019 – Novartis announced results from two new clinical trials evaluating improvement in heart structure and function and long-term safety of Entresto (sacubitril/valsartan) in patients with heart failure with reduced ejection fraction (HFrEF).

September 4, 2019 — Final data from the World Alliance Societies of Echocardiography (WASE) Normal Values Study was presented as part of the late-breaking science at the European Society of Cardiology (ESC) Congress, Aug. 31-Sept. 4 in Paris, France. The data presented focuses specifically on 2-D left ventricular dimensions, volumes and function. 

Shockwave Medical Inc. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Shockwave intravascular lithotripsy (IVL) system with the Shockwave C2 Coronary IVL Catheter. The device is currently the subject of an Investigational Device Exemption (IDE) study called DISRUPT CAD III. The Shockwave C2 IVL Catheter is a proprietary tool designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion, thereby improving blood flow to the heart muscle.

Corindus Vascular Robotics Inc. announced that EClinicalMedicine, a clinical journal published by The Lancet, has published the results from the Telerobotic Intervention Study, the world’s first percutaneous coronary intervention (PCI) procedures conducted from a remote location outside the catheterization lab. The study was conducted using Corindus’ CorPath technology platform.

New Zealand-based Adept Medical announced the launch of the Antegrade IR Platform. Clinically driven, it is placed to provide an ideal work surface for antegrade femoral approach during interventional radiology vascular procedures. The device sits within the company’s existing range of access and patient positioning devices designed for interventional radiology, cardiology and vascular procedures.

The most popular cardiac technology news in August 2019 was the FDA clearance for a new indication for both the Edwards Sapien 3 and Medtronic CoreValve transcatheter aortic valve replacement (TAVR) devices for low-risk patients. This puts the technology on equal footing with the previous standard-of-care of open heart surgery, representing a paradigm shift in cardiology.

September 3, 2019 — Here is the list of the most popular content on the Diagnostic and Interventional Cardiology (DAIC) magazine website from the month of August 2019. This is based on the website’s record 310,328 pageviews for the month:

1. FDA Approves TAVR for Low-risk Patients Creates A Paradigm Shift in Cardiology

Philips will showcase its latest cardiac care innovations at the European Society of Cardiology (ESC) Congress 2019, Aug. 31–Sept. 4 in Paris, France. At the congress, Philips is showcasing Release 5.0 of its Epiq CVx cardiology platform for the first time in Europe. The platform includes automated applications for 2-D assessment of the heart, as well as robust 3-D right ventricle volume and ejection fraction measurements, making accurate exams faster and easier to conduct. Philips also announced that it is collaborating with digital health company LindaCare to combine the latter’s OnePulse cloud-based solution for the remote monitoring of patients with cardiac implantable electronic devices (CIEDs) with the Philips IntelliSpace Cardiovascular informatics platform.

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