The Latest Cardiac and Vascular News
DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s (NASDAQ: ABMD) Impella ECP expandable percutaneous heart pump. The designation means the FDA will prioritize Impella ECP’s regulatory review processes including design iterations, clinical study protocols and pre-market approval (PMA) application. Impella ECP is the smallest […]
SELENE HF adds to existing evidence that HF decompensation starts several weeks before hospitalization BERLIN, Aug. 18, 2021 /PRNewswire/ — BIOTRONIK today announced the results from a new study published in EUROPACE this week confirming that heart failure (HF) decompensation can be predicted early when monitored using an algorithm that combines existing remote monitoring trends and baseline […]
Double-blind, randomized trial data show a clinically meaningful and statistically significant net reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure at 6 months in treated vs. control patients Very high (85%) response rate to therapy despite 81% of treated patients having isolated systolic hypertension (ISH), a more dangerous […]
TIANJIN, China, Aug. 17, 2021 /PRNewswire/ — SINOMED, a leading international medical device company, announced the first commercial implantation of the HT Supreme® Drug-Eluting Stent (DES) at University Hospital Galway in partnership with the National University of Ireland Galway (NUI Galway), marking the start of the European launch. The procedure was successfully performed by […]
VANCOUVER and MINNEAPOLIS, Aug. 17, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that it has filed a supplement to the COSIRA-II Investigational Device Exemption (IDE) Study with the U.S. Food and Drug Administration (FDA). Following multiple productive discussions with FDA over the […]
Advanced design makes sample collection simple, efficient, and safe SOUTH JORDAN, Utah, Aug. 16, 2021 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy, […]
SCHAFFHAUSEN, Switzerland, Aug. 16, 2021 /PRNewswire/ — Occlutech Holding AG (“Occlutech”), one of the world´s leading providers of minimally invasive structural heart disease devices, announces the conditional U.S. Food and Drug Administration (“FDA”) approval of its Investigational Device Exemption (“IDE”) application to conduct a pivotal study, OCCLUFLEX, comparing Patent Foramen Ovale (“PFO”) closure by […]
IRVINE, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced FDA approval for the company to initiate its Investigational Device Exemption (IDE) PMA clinical trial for the Trilogy™ Heart Valve System for severe symptomatic, high-surgical risk […]
FDA Breakthrough Designation Granted to CytoSorbents’ DrugSorb-ATR for Removal of Apixaban and Rivaroxaban to Reduce the Risk of Serious Bleeding in Urgent Cardiothoracic Surgery MONMOUTH JUNCTION, N.J., Aug. 12, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its […]
Levosimendan was shown to Reduce Stressed Blood Volume (SBV), a Novel and Highly Relevant Mechanism of Action for PH-HFpEF Patients Stressed Blood Volume Reductions Accompany Previously Reported Improvements in Important Cardiovascular Hemodynamic Measurements Reduction in Stressed Blood Volume Suggests the Effects of Levosimendan are Modulated Through K-ATP Channel Activation and […]
