Clinical

This channel newsfeed includes clinical content on treating patients or the clinical implications in a variety of cardiac subspecialties and disease states. The channel includes news on cardiac surgery, interventional cardiologyheart failure, electrophysiologyhypertension, structural heart disease, use of pharmaceuticals, and COVID-19.   

Valiant Captivia Thoracic Stent Graft System from Medtronic receives FDA approval for treating aortic dissections

Continuing to expand the role of endovascular aortic repair, Medtronic, Inc. (NYSE: MDT) has received approval from the U.S. Food and Drug Administration (FDA) for the Valiant Captivia Thoracic Stent Graft System to be used in the treatment of type B aortic dissections, a serious cardiovascular condition associated with high morbidity and mortality in which the upper segment of the body's main artery has become torn along the innermost layer of the vessel wall.

Baptist Foundation awards grant to AMGA's Measure Up/Pressure Down(TM) campaign

The American Medical Group Association announced today that the Baptist Memorial Health Care Foundation has awarded a grant to the Measure Up/Pressure Down(TM) campaign to help improve the rates of high blood pressure control among patients in the health system's region.

St. Jude Medical gains CE Mark for 25 mm Portico Transcatheter Aortic Heart Valve

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, has received European CE Mark approval for its 25 mm Portico™ Transcatheter Aortic Heart Valve Implantation System. The approval expands the number of patients who can be treated using the Portico heart valve during transcatheter aortic valve replacement (TAVR) procedures. TAVR is an option for patients with symptomatic severe aortic stenosis (a narrowing of the aortic heart valve that obstructs blood flow from the heart). These patients are considered high-risk for conventional open-heart valve replacement surgery.

Amgen announces positive top-line results from Phase 3 RUTHERFORD-2 Trial Of Evolocumab (AMG 145) in patients with heterozygous familial hypercholesterolemia

Amgen (NASDAQ:AMGN) today announced that the Phase 3 RUTHERFORD-2 (RedUction of LDL-C with PCSK9 InhibiTion in HEteRozygous Familial HyperchOlesteRolemia Disorder Study-2) trial evaluating evolocumab in combination with statins and other lipid-lowering therapies in patients with heterozygous familial hypercholesterolemia (HeFH) met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12.

Amgen announces positive top-line results from Phase 3 LAPLACE-2 Trial Of Evolocumab (AMG 145) in combination with statins in patients with high cholesterol

Amgen (NASDAQ:AMGN) today announced that the Phase 3 LAPLACE-2 (LDL-C Assessment with PCSK9 MonoclonaL Antibody Inhibition Combined with Statin ThErapy-2) trial evaluating evolocumab in combination with statin therapy in patients with high cholesterol met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The mean percent reductions in LDL-C, or "bad" cholesterol, were consistent with the published results observed for the same doses in the Phase 2 LAPLACE-TIMI 57 (LAPLACE-Thrombolysis In Myocardial Infarction-57) trial for evolocumab compared to placebo; and in the Phase 2 MENDEL (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not Receiving Drug Therapy For Easing Lipid Levels) study for evolocumab compared to ezetimibe.

iRhythm announces that ZIO(r) Service included under new Aetna policy covering long-term continuous monitoring of patients with suspected heart arrhythmias

iRhythm Technologies, a healthcare information services company, today announced that Aetna, the third largest health plan in the United States, has issued a positive coverage policy for long-term continuous monitoring of patients with suspected heart arrhythmias, which includes use of the ZIO Service. The new policy now makes iRhythm's solution - comprised of the ZIO Patch, proprietary algorithms and the ZIO report - available as a potential covered service for the insurer's medical members.

Israel Ministry of Health approves clinical trials for BioControl Medical's CardioFit(r) System in heart failure

BioControl Medical, a medical device company headquartered in Yehud, Israel, has received approval from the Israel Ministry of Health to conduct clinical trial of its CardioFit(r) system in patients with chronic heart failure (HF) as part of INOVATE-HF. With the approval, Israel will join European countries and the United States to participate in the company's third phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a U.S. Food and Drug Administration-approved investigational device exemption (IDE) study of CardioFit being conducted in 80 centers worldwide.

Beaumont Health System first outside of Japan to test new atrial fibrillation technology

Beaumont Health System is the first center outside of Japan to use a new balloon ablation technology to treat atrial fibrillation, the most common heart rhythm disorder that affects about 3 million people in the U.S.

Around the web

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.