Valtech Cardio Ltd. announced that it has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 1 approval for the Cardioband Mitral Reconstruction System, its flagship device for addressing mitral regurgitation in heart failure patients.

Mount Sinai Heart is undertaking a three-year study to determine whether a workplace-based lifestyle intervention, accompanied by imaging data, will reduce the prevalence of cardiovascular (CV) disease risk factors related to lifestyle.

Columbia Engineering researchers have shown, for the first time, that electrical stimulation of human heart muscle cells (cardiomyocytes) engineered from human stem cells aids their development and function.

The following are the late-breaking clinical trial presentations presented at the 2016 American College of Cardiology (ACC) meeting April 2-4 in Chicago. The trials below were chosen based on the importance of their contribution to cardiovascular science. Click on the highlighted text to see the articles related to each presentation.

Joint ACC/JACC Late-Breaking Clinical Trials
April 2, 2016, 9 a.m., Main Tent (North Hall B1)

February 9, 2016 — Boston Scientific Corp. announced the Centers for Medicare and Medicaid Services (CMS) will cover percutaneous left atrial appendage (LAA) closure therapy under specific criteria, as outlined in the agency's final National Coverage Determination (NCD). This decision, effective immediately, provides consistent and uniform access to the Watchman LAA closure Device as a non-pharmacological treatment option for stroke risk reduction for appropriate Medicare beneficiaries. 

European Society for Vascular Surgery XXX Annual Meeting

transcatheter repair of a mitral valve paravalvular leak. Transcatheter repair of a surgical mitral replacement paravalvular leak with an Amplatzer Vascular Plug II.
paravalvular leak. This 3-D TEE image shows a paravalvular leak in the 2 o'clock position on the surgical valve implant. Friable cardiac tissue in the elderly and patients with certain conditions can result in sutures pulling out of the tissue, opening gaps around the valve. If the regurgitation of these openings is severe enough, it can cause heart failure or hemolysis.
Paravalvular leak. Paravalvular leaks marked in white around a surgical valve replacement.
Paravalvular leak seen on cardiac ultrasound.
Paravalvular leak repair using eight Amplatzer II devices around a mechanical valve replacement. The large Amplatzer device to the right is a an earlier repair for a septal defect.
The Amplatzer Vascular Plug II illustrated in its intended use as a vacular occluder device.
Amplatzer Vascular Plug, II, III, IV. The Amplatzer Vascular Plug II (left to right), Amplatzer Vascular Plug III and the Amplatzer Vascular Plug IV devices.

Off-label use of the St. Jude Amplatzer vascular plug devices offers a new solution for the minimally invasive repair of paravalvular leaks. Paravalvular leaks around surgical valve implants can result in poor outcomes, and the heart needing to work harder to pump can lead to heart failure. The small holes that cause paravalvular leak also form a Venturi effect, causing fast-moving jets that can lead to red blood cell destruction (hemolysis), causing anemia and fatigue. 

February 8, 2016 — A parent’s incarceration has immediate, devastating effects on a family. Now, Virginia Tech and University of Toronto researchers say there may be a longer term risk: Men who as children experienced a family member’s incarceration are approximately twice as likely to have a heart attack in later adulthood in comparison with men who were not exposed to such a childhood trauma.

MedStar Heart & Vascular Institute at MedStar Washington Hospital Center is one of two hospitals in the nation selected to partner with the American College of Cardiology (ACC) on the Find Your Heart a Home pilot program.

St. Jude Medical Inc. announced the launch of the company’s Optis Mobile System in Japan and Europe. The diagnostic system is designed to couple state-of-the-art optical coherence tomography (OCT) and angiography co-registration with fractional flow reserve (FFR) technology into one portable system for hospitals with multiple catheterization labs.

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