Articles

Researchers have announced the results of a clinical study that shows a key difference in the patient’s baseline heart size and function following transcatheter valve replacement (TAVR) that may...

With recent medical device advances have come increasing concerns about the ability of the United States to remain at the forefront of research, especially in light of stringent FDA policies...

Abbott has announced publication of positive outcomes from two European post-approval studies of the catheter-based MitraClip therapy for the treatment of mitral regurgitation (MR). Results...

Direct Flow Medical Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin the SALUS feasibility...

June 3, 2013 — Medtronic Inc. announced it has received CE mark for valve-in-valve (VIV) procedures using the CoreValve and CoreValve Evolut transcatheter aortic valve implantation (TAVI) systems...

Philips, TEE, mitral valve

The development of 3-D transesophageal echo (TEE) just a few years ago has enabled a new generation of interventional procedures to be performed, which otherwise would have been...

Abbot MitraClip

Abbott announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted by majority (Yes: 5, No: 3) that the benefits...

Edwards Sapien, PARTNER, 3 year followup

The three-year results of a pivotal clinical study comparing the Edwards Sapien transcatheter heart valve and open-heart surgery demonstrated comparable outcomes. These new data from The PARTNER...

Edward Structural Heart Valve Repair Clinical Trial Sapien XT Transcatheter

Edwards Lifesciences Corporation announced that preliminary results from The PARTNER II Trial demonstrated similar one-year outcomes in mortality and major clinical events between the Edwards...

Engager TAVI valve

Medtronic Inc. announced European CE (Conformité Européenne) mark approval for its Engager Transcatheter Aortic Valve Implantation (TAVI) System with transapical delivery catheter. The system...