W. L. Gore & Associates Inc. (Gore) announced the U.S. Food and Drug Administration (FDA) has granted regulatory approval for commercial distribution of the Gore Tag Conformable Thoracic Stent Graft with Active Control System. The device is a thoracic endovascular aortic repair (TEVAR) solution combining new levels of control with the performance of the Conformable Gore Tag Device. The device and delivery system provide new precision and predictable patient outcomes in the endovascular repair of aneurysms, transections and Type B dissections of the descending thoracic aorta. A smaller-diameter primary delivery sleeve gives the device and system a lower profile across 10 device sizes.

Cordis, a Cardinal Health company, recently announced the full U.S. launch of its Radial 360 portfolio, offering a complete range of products to facilitate the transradial approach (TRA) for interventional cardiology procedures.


May 15, 2019 — The Heart Rhythm Society (HRS) had 21 late-breaking study presentations at the 2019 Heart Rhythm Scientific Sessions. Here is a completed list of the studies presented with links to more information. This includes the latest in clinical research, techniques and technologies in cardiac electrophysiology (EP). For more details on HRS 2019, visit www.hrssessions.org.

 


Artificial intelligence (AI) solutions provider Aidoc has been granted U.S. Food and Drug Administration (FDA) clearance for an additional product in its expanding suite of AI-based workflow orchestration solutions. The clearance is for Aidoc's Pulmonary Embolism (PE) solution that works with radiologists to flag and triage PE cases in chest computed tomography (CT) scans. The approval comes just weeks after Aidoc closed a $27 million funding round, bringing its total funding to $40 million.


May 15, 2019 — A new study shows electromechanical wave imaging is capable of localizing arrhythmias including atrial tachycardia (AT), atrial flutter (AFL), premature ventricular complexes (PVC), and accessory pathways (AP) in Wolff-Parkinson-White syndrome prior to catheter ablation. The double-blinded study for this new technology was presented as a late-breaking session at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions.


May 15, 2019 — A new infection risk scoring system has been developed based on data from the large PADIT Trial.[1] The new scoring system was presented as a follow up to that study during a late-breaking session at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions.

May 15, 2019 — Renal artery denervation (RDN) was found to be safe when employed with pulmonary vein isolation (PVI) to patients with paroxysmal atrial fibrillation (AF) and hypertension and significantly increased the likelihood of freedom from AF in a single-blind, randomized clinical trial.

May 15, 2019 - Three new studies show that patients who are medically indicated for implantable heart devices, including implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT), often do not receive needed therapy. The findings underscore gender and race treatment disparities, as well as a lack of referrals to physicians to implant the devices.

May 15, 2019 — A pilot trial has shown His pacing in cardiac resynchronization therapy (CRT) has been shown to circumvent proximal left bundle branch block (LBBB) and restore electrical resynchronization in patients with heart failure. Results from the study were presented during a late-breaking session at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions.

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