Neovasc Inc. has received conditional Investigational Device Exemption (IDE) approval from the U.S. FDA to initiate the U.S. arm of its Tiara-I Early Feasibility Trial for the company's Tiara transcatheter mitral valve. The Tiara-I Early Feasibility Trial is a multinational, multicenter trial being conducted to assess the safety and performance of Neovasc's Tiara mitral valve system and implantation procedure in high-risk surgical patients suffering from severe mitral regurgitation (MR).


Imricor Medical Systems Inc. announced that it has entered into a license agreement with Sorin Group to develop magnetic resonance imaging (MRI) compatible leads for use with Sorin implantable cardiac rhythm management devices.

Using stents to keep neck arteries open is just as effective as invasive neck surgery for long-term prevention of fatal and disabling strokes, reports an international trial led by UCL (University College London) funded by the Medical Research Council and Stroke Assn.

 

Imricor Medical Systems, Inc. announced the first three cardiac ablation procedures were completed in the first clinical study that is evaluating the feasibility of their magnetic resonance (MR)-enabled products to treat atrial flutter. Prof. Reza Razavi, head of the Division of Imaging Sciences and Biomedical Engineering, King's College London, is the principal investigator for the study and performed the procedures along with Mark O'Neill, professor of cardiac electrophysiology and consultant cardiologist, Guy's and St. Thomas' NHS Trust in the United Kingdom, The prospective pilot study will enroll up to 15 patients at this center.


October 15, 2014 — AtriCure, Inc. today announced enrollment in the ABLATE Post Approval Study (PAS) is complete.

October 15, 2014 — Novartis Pharmaceuticals Canada Inc. revealed, in the largest heart failure study to date, that its investigational heart failure medicine, LCZ696, was superior to the ACE-inhibitor enalapril on key endpoints. The results were released at the 2014 European Society of Cardiology (ESC) Congress and published simultaneously in the New England Journal of Medicine.

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