News | 07.01.20
IDE Approved for Trial of Carag’s Transcatheter Bioresorbable Septal Occluder
July 1, 2020—Carag AG, a Switzerland-based medical device company, announced it has received FDA investigational device exemption approval for the Carag bioresorbable septal occluder (CBSO), the company’s transcatheter septal occluder with a bioresorbable, metal-free framework.
News | 06.30.20
IDE Approved for Pivotal Study of Ancora Heart's AccuCinch Ventricular Restoration System
June 30, 2020—Ancora Heart, Inc. announced FDA approval of its investigational device exemption (IDE) application for the CorCinch-HF pivotal study, which is designed to evaluate the safety and efficacy of the company's AccuCinch ventricular restoration system in patients with heart failure and reduced ejection fraction.
News | 06.25.20
Abbott Announces New Data for its Structural Heart Device Portfolio
June 25, 2020—Abbott announced the presentation of late-breaking data at the virtual PCR e-Course held online June 25 to 27, including studies of its transcatheter devices for the treatment of mitral regurgitation (MR) and tricuspid regurgitation (TR).
News | 06.01.20
FDA Issues Emergency Use Authorization for Impella RP as Therapy for COVID-19 Patients With Right Heart Failure
June 1, 2020—Abiomed announced that the FDA has issued an emergency use authorization (EUA) for the company’s Impella RP to include patients with COVID-19–related right heart failure or decompensation, including pulmonary embolism (PE).
News | 05.28.20
SMT Enters Structural Heart Market With Acquisition of Vascular Concepts
May 28, 2020—Sahajanand Medical Technologies Pvt Ltd (SMT), a global medical device company based in India, announced its entry into the structural heart segment with the acquisition of Vascular Concepts, which is also headquartered in India.
News | 05.15.20
Medtronic Presents Data on Melody and Harmony TPV Devices for Congenital Heart Disease
May 15, 2020—Medtronic announced the results from two late-breaking clinical trials presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2020 Scientific Sessions Virtual Conference held May 14–16.
News | 05.08.20
PINNACLE FLX 12-Month Data Reported for Boston Scientific's Watchman FLX LAAC Device
May 8, 2020—Boston Scientific Corporation announced that 12-month results from the PINNACLE FLX clinical trial were presented as a late-breaking clinical trial at HRS 2020 Science, the annual Heart Rhythm Society Scientific Sessions being held as a virtual conference because of the COVID-19 pandemic.
News | 05.02.20
Venus Medtech Partners With Opus Medical Therapies to Develop Transcatheter Valve Technology for the Greater China Market
May 2, 2020— Venus Medtech (Hangzhou) Inc., a Chinese transcatheter heart valve company, and Opus Medical Therapies, LLC, an Atlanta, Georgia–based medical device company focused on developing transcatheter mitral valve replacement (TMVR) and transcatheter tricuspid valve replacement (TTVR) products, announced a partnership agreement to develop, manufacture, and sell these TMVR and TTVR devices in Greater China.
News | 04.16.20
SCAI Position Statement Addresses Training for Treatment of Adult Congenital Heart Disease
April 16, 2020—The Society for Cardiovascular Angiography and Interventions (SCAI) announced it has released a position statement on adult congenital cardiac interventional training, competencies, and organizational recommendations.
News | 03.29.20
Boston Scientific’s Watchman Device Evaluated in NCDR’s Postmarket LAAO Registry
March 29, 2020—Procedures to implant the Watchman left atrial appendage occlusion device (LAAO; Boston Scientific Corporation) had a high implant success rate and a low rate of in-hospital complications in an analysis of more than 38,000 procedures.
News | 03.10.20
European Postmarket Registry Commences for Carag Bioresorbable Septal Occluder
March 10, 2020—Carag AG, a Swiss medical device development company, announced the successful first implantation of the company’s transcatheter septal occluder with bioresorbable, metal-free framework as part of a new international postmarket registry.
News | 02.25.20
Pooled Analysis Supports Long-Term Benefits of Cardiac Dimensions’ Carillon System for FMR
February 25, 2020—Cardiac Dimensions, a developer of treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), announced the findings of a post hoc analysis of pooled, prospectively collected data from three studies of the company’s Carillon mitral contour system.
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.
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.