Introduction of Orbital Atherectomy Expands Treatment Options for Patients with Peripheral Artery Disease ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patient in the United […]
Author: Ken Dropiewski
Medtronic Receives FDA Breakthrough Device Designation for Developing Stent Graft System to Treat Thoracoabdominal Aortic Aneurysm
News Follows Medtronic Receiving FDA Breakthrough Device Designation for its Valiant Navion™ LSA Branch Thoracic Stent Graft System DUBLIN, Oct. 08, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Valiant® TAAA Stent Graft System […]
PQ Bypass Announces Unconditional IDE Approval From U.S. FDA to Start TORUS SFA Stent Graft Pivotal Study (TORUS-2)
TORUS-2 marks second Investigational Device Exemption approved for company in less than two years. MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass, Inc., a clinical-stage medical device company, today announced it has received full approval of its investigational device exemption (IDE) trial of the company’s TORUS stent graft, a novel stent graft platform designed […]
BioVentrix Enrolls and Treats First Patient in REVIVE-HF European RCT for Ischemic Heart Failure Patients
SAN RAMON, Calif., Oct. 8, 2019 /PRNewswire/ — BioVentrix, Inc. announced the first patient was enrolled and treated in the REVIVE-HF European study, a prospective multi-center, dual-arm randomized controlled study evaluating the treatment of ischemic cardiomyopathy induced heart failure with the Revivent TCTM System compared to Guideline-Directed Medical Therapy (GDMT) or drug treatment. The patient […]
BioCardia Receives CE Mark Renewal For Helix Biotherapeutic Delivery Catheter And Morph Guide Catheter Through May 2024
SAN CARLOS, Calif., Oct. 08, 2019 (GLOBE NEWSWIRE) — BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced renewal of the CE Mark for the Helix™ Biotherapeutic Delivery Catheter and Morph® Universal Deflectable Guide Catheter, both used in the delivery of biotherapeutics to the heart. CE Mark renewal enables […]
Kardium® announces successful results from the GLOBAL-AF study
VANCOUVER, British Columbia–(BUSINESS WIRE)–Kardium Inc. today announced that the Globe® mapping and ablation system has successfully demonstrated safety and efficacy in the GLOBAL-AF study. The results of the study were published in the Journal of Cardiovascular Electrophysiology. The study demonstrated a 76% percent freedom from atrial fibrillation at 12 months after a […]
Medtronic Initiates Worldwide Pivotal Study of a New Approach to Treating Dangerously Fast Heart Rhythms
Study to Evaluate Novel Implantable Defibrillator System with a Lead Placed Outside the Heart and Veins DUBLIN, Oct. 07, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced the start of a worldwide pivotal study evaluating its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system to treat dangerously fast heart rhythms. The […]
Abiomed Announces 1,000th Patient Treated with Impella in Japan
TOKYO–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, announces the 1,000th patient has been treated with the Impella heart pump in Japan. The Impella 2.5 and Impella 5.0 heart pumps are approved for the treatment of drug-resistant acute heart failure and are the first and only percutaneous temporary […]
Diagnomics Releases Cardiovascular Health Panel on Clinical Microarray Platform
SAN DIEGO, Oct. 7, 2019 /PRNewswire/ — Diagnomics Inc., a San Diego-based genetic testing company, is releasing a cardiovascular-focused genetic report through the Illumina Global Screening Array platform. The new clinical report, Cardiac Care, is now added to the company’s established clinical portfolio, Gene Impetus, that emphasizes medically actionable panels generated from genomic data […]
Accelmed Launches Accelmed Ventures II, a New $100 Million Venture HealthTech Fund
The new fund has already received a commitment from an anchor investor, Vincent Tchenguiz Recent exits of Accelmed’s ventures portfolio companies include the acquisition of Eximo Medical by AngioDynamics for $66 million and Endospan, that entered into an option agreement to be acquired by CryoLife for a total of up […]



