The Latest Cardiac and Vascular News
TAMPA, Fla., Sept. 17, 2022 /PRNewswire/ — The US FDA has granted an Investigational Device Exemption (IDE) approval for MagicTouch Sirolimus Coated Balloon (SCB) indicated for In-Stent Restenosis (ISR). US FDA’s IDE approval allows the MagicTouch SCB to be used in a pivotal clinical study to support safety and effectiveness of this combination product. The data generated […]
BOSTON, Sept. 17, 2022 /PRNewswire/ — Edwards Lifesciences Corporation ( NYSE: EW) announced results from CLASP IID, the first randomized controlled trial that directly compares two contemporary transcatheter edge-to-edge repair (TEER) therapies. The study confirms TEER as a safe and effective therapy in patients with degenerative mitral regurgitation (DMR). Results from the CLASP IID […]
EMPOWER CAD is the First Prospective, Female-Only Study of Coronary Interventions Study Seeks to Confirm Benefits of Shockwave’s Coronary IVL in Females Who Historically Have Suffered Less Favorable Clinical Outcomes than Male Patients with Traditional Therapies SANTA CLARA, Calif., Sept. 19, 2022 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in […]
FEops HEARTguide significantly improves efficiency and outcomes of LAAO procedures in the PREDICT-LAA Randomized Clinical Trial GENT, Belgium–(BUSINESS WIRE)–Data from the PREDICT-LAA trial, presented at the Late-Breaking Innovation session at the TCT 2022 convention in Boston shows that Left Atrial Appendage occlusion (LAAO) procedures planned by means of FEops HEARTguideTM result […]
BOSTON–(BUSINESS WIRE)–Results of a three-year, investigator-led study of all Impella-supported patients treated at 109 hospitals in Japan (n=1,344) show 30-day survival rates of 81% for AMI cardiogenic shock (AMICS) patients. The study is an update to a 2020 interim analysis and was presented at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) conference taking […]
FDA Also Approves and Closes RECOVER III Post-Approval Study DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces two approvals from the U.S. Food and Drug Administration (FDA) related to clinical research of Impella heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients. The FDA has approved the on-label RECOVER IV randomized controlled […]
Interim data from the cardiomyopathy arm of the Phase 1 study of NTLA-2001 showed deep and sustained mean serum transthyretin (TTR) reductions of 93% and 92% at 0.7 mg/kg and 1.0 mg/kg doses, respectively, at day 28 NTLA-2001 was generally well-tolerated at both dose levels Intellia to discuss data at […]
New Heart Valve Durability tester with Automatic Dual Control technology debuts at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. “Introducing a New Generation of Durability Testers” VICTORIA, BC, Sept. 16, 2022 /PRNewswire/ — ViVitro Labs, the industry-leading provider of cardiovascular device test equipment and related […]
Three leading U.S. interventional cardiologists attend initial cases as company prepares to expand its clinical program LOS GATOS, Calif., Sept. 16, 2022 /PRNewswire/ — Supira Medical, Inc., a Shifamed portfolio company focused on developing the next-generation solution for mechanical circulatory support, announced today it has initiated its first-in-human clinical study performed by principal […]
IRVINE, Calif., Sept. 15, 2022 /PRNewswire/ — Edwards Lifesciences Corporation ( NYSE: EW), today announced the company’s PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) has received FDA approval for the treatment of patients with degenerative mitral regurgitation (DMR). “Patients suffering with debilitating symptoms as a result of degenerative mitral regurgitation represent a […]
