News | 02.03.20
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).
News | 02.03.20
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.
News | 12.04.19
One-Year Outcomes Published for BioVentrix's Revivent TC System
December 4, 2019—BioVentrix, Inc., developer of a less invasive system for left ventricular remodeling, announced the publication of positive 1-year results from its CE Mark approval study of the Revivent TC transcatheter ventricular enhancement system.
News | 12.02.19
Long-Term Data Reported From Continued Access Registries of Boston Scientific's Watchman LAAC Device
December 2, 2019—Findings from continued access registries on the long-term safety and efficacy of the Watchman left atrial appendage closure (LAAC) device (Boston Scientific Corporation) for stroke prevention in patients with nonvalvular atrial registries were published by David R. Holmes Jr, MD, et al in Journal of the American College of Cardiology (JACC; 2019;74:2878–2889). The investigators sought to evaluate 4.5- to 5-year data in two FDA-mandated registries for safety and efficacy of LAAC with the Watchman device: CAP (Continued Access to PROTECT-AF) and CAP2 (Continued Access to PREVAIL).
News | 10.31.19
Abiomed Begins Controlled Rollout of Impella 5.5 With SmartAssist in the United States
October 31, 2019—Abiomed, Inc. announced that the Impella 5.5 with SmartAssist, a forward flow heart pump, is being introduced in the United States through a controlled rollout at hospitals with established heart recovery protocols.
News | 10.25.19
Abiomed Presents Real-World Postapproval Data for Impella RP
October 25, 2019—Abiomed, Inc. announced that real-world outcomes data at approximately 2 years show that when physicians followed the FDA’s approved protocol for the company’s Impella RP device, they achieved 72% patient survival and 88% native heart recovery.
News | 09.26.19
FDA Grants Premarket Approval for Abiomed's Impella 5.5 With SmartAssist
September 25, 2019—Abiomed, Inc. announced it has received FDA premarket approval (PMA) for its newest heart pump, the Impella 5.5 with SmartAssist, for safety and efficacy in the therapy of cardiogenic shock for up to 14 days.
News | 08.15.19
PreCardia Initiates VENUS-HF Early Feasibility Study in Patients With Acute Decompensated Heart Failure
August 15, 2019—PreCardia, Inc., which is developing technologies for the treatment of acute decompensated heart failure (ADHF), announced the enrollment of the first patient in the VENUS-HF Early Feasibility Study.
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.