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Philips’ DEFINE GPS Trial Will Assess Outcomes of PCI Guided by an Integrated Platform of iFR and Angiogram
February 11, 2020—Royal Philips announced a new randomized controlled trial to assess patient outcomes after receiving percutaneous coronary intervention (PCI) guided by Philips’ coregistration platform (which combines data of instant wave-free ratio (iFR) measurement and angiography) compared with the standard of care treatment guided by angiography alone.
Study Demonstrates Relationship Between Hospital SAVR Volume and TAVR Outcomes
February 10, 2020—Sameer A. Hirji, MD, et al conducted a study that examined whether hospital surgical aortic valve replacement (SAVR) volume was associated with corresponding transcatheter aortic valve replacement (TAVR) outcomes. The investigators published the findings from the study in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2020;13:335–343).
JenaValve Technology Closes $50 Million Financing Equity Round
February 5, 2020—JenaValve Technology, Inc. announced that it has raised $50 million in equity financing to support an ongoing clinical program for the company’s JenaValve pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease.
CardioFocus Makes PMA Supplement Submission to FDA for the HeartLight X3 Endoscopic Ablation System
February 4, 2020—CardioFocus, Inc. announced that it has submitted a premarket approval (PMA) supplement to the FDA for the company’s HeartLight X3 endoscopic ablation system to treat atrial fibrillation (AF).
Medtronic Begins SPYRAL DYSTAL Pilot Study of Renal Denervation in Hypertensive Patients
February 4, 2020—Medtronic announced it will begin enrollment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation (RDN) system using a targeted procedural approach with a reduced number of radiofrequency (RF) ablations.
Expansion of Ancora Heart’s CorCinch HFrEF Early Feasibility Study Approved by FDA
February 3, 2020—Ancora Heart, Inc. announced that the FDA has approved an expansion of enrollment in the company's early feasibility study (EFS) evaluating the AccuCinch ventricular repair system in patients with reduced ejection fraction heart failure (HFrEF).
FDA Approves CATALYST Trial Comparing Abbott’s Amplatzer Amulet LAA Occluder Versus NOACs
February 3, 2020—Abbott announced that the FDA has approved the CATALYST trial, which is designed to assess the company’s Amplatzer Amulet left atrial appendage (LAA) occluder for patients with atrial fibrillation (AF) who are at risk of stroke.
US Device Guide
This Device Guides offers a searchable, comprehensive listing of the available interventional cardiology devices in the United States.
European Device Guide
This Device Guides offers a searchable, comprehensive listing of the available interventional cardiology devices in Europe.
TAVR Trials Guide
A summary of the study data for all of the TAVR devices available in the United States market.
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