Press Releases

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 (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 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.

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 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.

Temple University Hospital (TUH) could be among the first U.S.-based hospitals to test a new device known as a multilayer stent in patients suffering from aortic aneurysm, a condition characterized by the formation of a potentially life-threatening bulge in the aorta. Approved in Europe in 2010, the device has already been used to help hundreds of European patients with the condition, and Grayson H. Wheatley III, MD, FACS, Associate Professor of Surgery at Temple University School of Medicine, and Director of Aortic & Endovascular Surgery at TUH, thinks thousands more could benefit in the United States.

Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received CE Mark in Europe and is initiating the launch of its most advanced transcatheter aortic valve, the Edwards SAPIEN 3 valve.

Amgen (NASDAQ:AMGN) today announced that the Phase 3 GAUSS-2 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2) trial evaluating evolocumab in patients with high cholesterol who cannot tolerate statins 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, compared to ezetimibe were consistent with results observed in the Phase 2 GAUSS study.

Medtronic, Inc. (NYSE: MDT), today announced that the Medtronic SureScan(r) pacing systems - the first and only pacing systems in the United States that have been approved by the U.S. Food and Drug Administration (FDA) for use with magnetic resonance imaging (MRI) - are now approved for MRI scans positioned on any region of the body. Patients implanted with the Advisa DR MRI(r) or Revo MRI(r) SureScan pacing systems now can have MRI scans without positioning restrictions, including the chest area, which previously had been restricted.

Dr. Laxmi Mehta, clinical director of the women’s cardiovascular health program and associate director of education at the Center for Women’s Health at The Ohio State University Wexner Medical Center, has been elected to serve on the Board of Governors of the American College of Cardiology (ACC) as the first female ACC Governor for Ohio. Mehta's term will run March 2015-2018. She will concurrently serve as the president of the Ohio Chapter of the American College of Cardiology. She will serve as Governor-Elect beginning March 2014.

The Arizona Heart Foundation enhanced its School of Cardiac & Vascular Ultrasound by installing eight Toshiba AplioTM 500 ultrasound systems and one ViamoTM ultrasound to educate students with the most advanced technology. The school will use Toshiba’s ultrasound systems for its 18-month cardiovascular ultrasound program. The potential for research remains priority for the foundation as well as the school.

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the New Drug Application (NDA) for its investigational, oral, once-daily direct factor Xa-inhibitor SAVAYSATM (edoxaban) Tablets has been submitted to the U.S. Food and Drug Administration (FDA). In the U.S., Daiichi Sankyo is seeking approval for edoxaban for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF), as well as for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for the prevention of recurrence of symptomatic venous thromboembolism (VTE). SAVAYSA is the proposed brand name for edoxaban if approved for marketing in the U.S.

Three of the region’s leading medical institutions – Baylor College of Medicine, CHI St. Luke’s Health and the Texas Heart® Institute – have significantly expanded and enhanced their long-standing educational, clinical and research affiliations in conjunction with Englewood, Colo.-based Catholic Health Initiatives, which sponsors and operates the newly named CHI St. Luke’s Health.

CSL Behring today announced that Kcentra® (Prothrombin Complex Concentrate [Human]) has received U.S. Food and Drug Administration (FDA) approval for an expanded indication -- urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients needing an urgent surgery or other invasive procedure. Kcentra, approved by the FDA in April 2013 for the urgent reversal of warfarin therapy in adult patients with acute major bleeding, is the only non-activated 4-factor prothrombin complex concentrate (4F-PCC) indicated in the U.S. for these uses.

The interventional cardiology team led by Ehtisham Mahmud, MD, FACC, at UC San Diego Sulpizio Cardiovascular Center (SCVC) has successfully completed the first two robotically-assisted coronary angioplasty/stent procedures in California. Patients with coronary artery disease (CAD) now have access to this new technology that puts the precision of a robot in the hands of interventional cardiologists during procedures to open clogged heart arteries.

The Icahn School of Medicine at Mount Sinai joins a top-flight network of 25 regional stroke centers announced by the National Institute of Health that will focus on prevention, treatment, and recovery from stroke. As part of the NIH Stroke Trials Network (NIHStrokeNet), the medical school will receive a 5-year, $1.3 million grant to build a collaborative research infrastructure for a regional coordinating stroke center.

A series of High Value Care case studies are available online for free from the American College of Physicians (ACP) to help clinicians understand the benefits, harms, and costs of tests and treatment options for common clinical issues so they can pursue care that improves health and eliminates wasteful practices.

Boston Scientific Corporation (NYSE: BSX) announces the appointment of Craig Thompson, M.D., as senior vice president and chief medical officer, Interventional Cardiology, effective immediately.  Dr. Thompson, a global leader in complex cardiac interventions, will play a key role in driving the development of innovative medical solutions within the Boston Scientific Interventional Cardiology business.

Results for a pilot registry on the management and treatment of atrial fibrillation (AF) in Europe were presented yesterday by the European Society of Cardiology (ESC). AF is the commonest cardiac rhythm disorder and each of us have a one-in-four lifetime risk of developing it. Statistics show that oral anticoagulant use has increased, but new oral anticoagulant (NOAC) use is still low. Authors also concluded that compliance with treatment guidelines for patients with the lowest and higher stroke risk scores remains suboptimal.

Digisonics and Medis are proud to announce a partnership to provide a comprehensive single system solution for image analysis and structured reporting of pediatric and adult CV MR studies. The integrated system solution between Digisonics and Medis will result in a seamless, efficient MR workflow.

Texas Children's Hospital is proud to be named the first Accredited Pediatric Heart Failure Institute in Texas by The Healthcare Accreditation Colloquium.