Conformal Medical Secures Financing to Support Pivotal Trial of CLAAS Technology
August 6, 2020—Conformal Medical, Inc., announced it has secured $85 million in Series C financing, which will be used to support the company’s United States pivotal trial of its next-generation Conformal left atrial appendage seal (CLAAS) technology in patients with atrial fibrillation (AFib).
Keystone Heart Launches TriGuard 3 Cerebral Embolic Protection Device in Europe
July 29, 2020—Keystone Heart, Ltd., a Venus Medtech company, announced the completion of the first commercial case using the TriGuard 3 cerebral embolic protection (CEP) device, which is designed to minimize the risk of cerebral damage during transcatheter heart procedures.
Canon Medical Introduces New Configuration of Aquilion One/Genesis Edition Cardiac CT Solution
July 17, 2020—Canon Medical Systems USA, Inc. announced the introduction of a new configuration of the Aquilion One/Genesis Edition, an artificial intelligence–powered wide-area CT system for structural and coronary imaging.
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.
Protaryx Receives Funding to Develop Technology for Left Atrial Access in Transcatheter Cardiac Procedures
June 30, 2020—Protaryx Medical announced that it has raised $8.3 million in funding to develop the company’s first-in-class device for precision transseptal access to the left atrium during structural heart and catheter ablation procedures.
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.
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).
PreCardia’s System to Treat Acute Decompensated Heart Failure Granted FDA Breakthrough Device Designation
June 23, 2020—PreCardia, Inc. announced that the company’s catheter-based system for treating volume overload in patients with acute decompensated heart failure (ADHF) has been designated for the FDA Breakthrough Devices program.
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).
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.
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.
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.
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.
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.