Edwards, Fortis, transcatheter mitral valve, trial, halts enrollment

Edwards Lifesciences announced it has temporarily halted its clinical trial of the Fortis mitral transcatheter heart valve. The company said that in consultation with trial investigators, it was decided to voluntarily implement a temporary pause on enrollment in its Fortis clinical program because of evidence of valve thrombosis. The company said the issue warrants additional investigation before restarting enrollment.

Abbott announced that it has received CE Mark for the latest advancement of its Absorb stent system, called Absorb GT1. Absorb GT1 combines a fully dissolving stent with a next-generation delivery catheter to help doctors treat people with heart disease. Built upon three generations of delivery catheter innovations, Absorb GT1 refers to the GlideTrack catheter, Abbott’s advanced stent delivery system, which is designed to make it easier for doctors to access and treat diseased vessels in people with coronary artery disease (CAD). The GlideTrack catheter incorporates several design and technology changes that have the potential to improve deliverability and performance.

Medtronic plc announced the Arctic Front Advance ST Cryoablation Catheter has received U.S. Food and Drug Administration (FDA) approval for the treatment of patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation. In Europe, where the Cryoballoon has a broader indication, Arctic Front Advance ST Cryoballoon has received CE Mark for the treatment of patients with atrial fibrillation.

A new service called MyChoiceMD is preparing to launch in Colorado that aims to revolutionize the way patients find, pay for, schedule and track their routine medical care. The service has been incubating in Northern Colorado and has completed a 10-month pilot in Cheyenne under the name Galen. It is targeted at the large population of self-pay patients that includes both insured and uninsured patients.

antiplatelet medication, prasugrel, clopidogrel, risk algorithm, SCAI

A risk assessment algorithm combining clinical risk factors and platelet function test results may help interventional cardiologists better identify patients who stand to benefit from intensive antiplatelet medication after percutaneous coronary intervention (PCI). This assessment is according to results of the TRIAGE study, presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2015 Scientific Sessions in San Diego.

New research reports significant differences between men and women with atrial fibrillation (AF) and the safety of intense physical activity. The study found that both moderate and vigorous levels of exercise are safe for women living with AF. However, vigorous levels of exercise are associated with an increased risk of AF in men. The research, analyzing data from a large-scale or robust patient population of nearly 380,000 patients, was presented at Heart Rhythm 2015, the Heart Rhythm Society’s 36th annual scientific sessions.

Patients with a high-risk paclitaxel drug-eluting stent given the shorter-acting antiplatelet drug cilostazol prior to a surgical procedure safely transitioned off of dual antiplatelet therapy (DAPT) to reduce bleeding risk during their operation. These new findings from the OUTSIDE START study were presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2015 Scientific Sessions in San Diego.

A largest-of-its kind study has found that women who experience menopause at a younger age are at a decreased risk of atrial fibrillation (AF). The study followed nearly 18,000 women and revealed that women experiencing menopause younger than 44 years had a significantly lower risk of AF than women entering menopause between the ages of 44-50. The research was presented at Heart Rhythm 2015, the Heart Rhythm Society’s 36th annual scientific sessions.

HRS, ECG, smartphones, atrial fibrillation, AF, Heart Rhythm 2015

A new, large-scale study has found adding an electrocardiogram (ECG) to the latest generation of body-worn sensors accurately detects atrial fibrillation (AF) and significantly increases awareness of heart rate and behavior. Body-worn or wearable wireless sensors are increasingly being used to help collect health-related information that can be shared with a doctor through a smartphone application. The study results show that by using ECG sensors with a smartphone application, the general adult population can efficiently track their heart rate data. The new findings were presented at Heart Rhythm 2015, the Heart Rhythm Society’s 36th annual scientific sessions.
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