News

Direct Flow Medical, Transcatheter Aortic Valve System, DISCOVER, EuroPCR

Direct Flow Medical Inc. announced positive two-year data from the DISCOVER CE Mark Trial studying its Direct Flow Medical Transcatheter Aortic Valve System at the EuroPCR conference in...

Greatbatch Medical, Myopore Sutureless Myocardial Pacing Lead

A new epicardial pacing lead has been cleared by the U.S. Food and Drug Adminitysration (FDA) as an option for the implant of a pacemaker, defibrillator, or cardiac resynchronization therapy (CRT...

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...

CardiAQ, TMVI, FDA, IDE, feasibility study, mitral valve, Beth Israel Deaconess

CardiAQ Valve Technologies announced U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for a feasibility study of its second generation transfemoral (TF) and...

Boston Scientific, investors, cardiology, growth, expansion

Boston Scientific Corp. presented an overview of its continued business momentum and long-term growth strategies at a meeting with the investment community May 1.

Pie Medical Imaging, 3mensio Structural Heart, mitral, septal crossing, workflow

Pie Medical Imaging announces its new release of 3mensio Structural Heart, dedicated to planning of structural heart interventions. This new release contains an optimized Mitral workflow and a new...

pulmonary valve replacement, congenital, re-intervention, age, PVR

A retrospective review of 633 adults and children who underwent bioprosthetic pulmonary valve replacement (PVR) for congenital heart disease between 1996 and 2014 indicated that the risk of re-...

Watchman, LAA, left atrial appendage

The long awaited U.S. Food and Drug Administration (FDA) approval of the first transcatheter left atrial appendage (LAA) occluder in March is seen by many cardiologists as a disruptive technology...

Minneapolis Heart Institute Foundation, TMVR, Tendyne, FDA, first implant, U.S.

Minneapolis Heart Institute Foundation (MHIF) physicians are conducting a research study using the first transcatheter mitral valve replacement in the United States at Minneapolis Heart Institute...

Comparing mechanical prosthetic and bioprosthetic mitral valves, a study in the April 14 issue of the Journal of the American Medical Association (JAMA) found no significant difference in...

3D Systems announced that a 20-month-old toddler is breathing and swallowing easier thanks to a team of cardiologists and cardiothoracic surgeons at Washington University School of Medicine in St...

Although ultrasound remains the primary imaging modality used in prenatal imaging, fetal magnetic resonance imaging (MRI) is playing an increasing role in further evaluation of fetuses suspected...

Medtronic, CoreValve, Japan, approval, trial

Medtronic announced Japanese regulatory approval for the self-expanding transcatheter CoreValve system for patients with severe aortic stenosis (AS). Japanese regulatory authorities granted...

Corevalve, VIV, valve in valve, FDA

The U.S. Food and Drug Administration (FDA) expanded the approved use of the CoreValve self-expanding transcatheter aortic valve replacement (TAVR) system to treat certain patients who have...

fetal pacemaker, CHLA, USC, first, fully implantable, FDA

A team of investigators at Children’s Hospital Los Angeles and the University of Southern California have developed the first fully implantable micropacemaker designed for use in a fetus with...

Edwards Lifesciences Corp. announced that chairman and CEO Michael A. Mussallem served as an invited expert panelist on behalf of the Advanced Medical Technology Association (AdvaMed) at the...

TAVR, transcatheter heart valves, GlobalData, TMVR

Research and consulting firm GlobalData reported that the global market value for transcatheter heart valves will expand at a Compound Annual Growth Rate (CAGR) of 19.7 percent through 2020,...

congenital heart disease, CHD, tPVR, consensus paper, minimally invasive

A new expert consensus paper released by a coalition of cardiovascular organizations provides guidance on transcatheter pulmonic valve replacement (tPVR) for children and adults who were...

Watchman, Mount Sinai, first, eastern United States, implant

Mount Sinai experts were the first in the eastern United States on March 23 to implant the Watchman device, a newly U.S. Food and Drug Administration (FDA)-approved device that prevents stroke in...

Edwards Lifesciences, Sapien 3, Partner, ACC.15, acc 2015

he Sapien 3 heart valve (Edwards Lifesciences) demonstrated lower death, stroke and paravalvular leak rates than earlier generation devices in patients at high risk for surgery and showed...