Shares in Cytokinetics Inc. closed down 42% Oct. 8 on news that omecamtiv mecarbil, a heart failure drug which it is developing with Amgen Inc. (with funding and strategic support from Les Laboratoires Servier SAS), failed to demonstrate a survival benefit in a large-scale cardiovascular outcomes study.
Cytokinetics Inc. as a competitor for Myokardia Inc.’s cardiovascular drug, mavacamten, didn’t come up until near the end of the conference call related to the $13.1 billion buyout of the latter company by Bristol Myers Squibb Co., but the prospect is on Wall Street’s mind.
The U.S. FDA has granted breakthrough device designation status to Medtronic plc’s Tyrx absorbable antibacterial driveline wrap, a medical device aimed at reducing driveline complications in patients receiving a ventricular assist device (VAD).
Eko Devices Inc. said Tuesday that it is collaborating with British pharma giant Astrazeneca plc to speed the development of digital health tools to improve early detection of cardiovascular diseases, including heart failure. The partnership could lead to more personalized care for heart failure patients, improving long-term outcomes.
The U.S. FDA has greenlighted Ancora Heart Inc.’s IDE request to conduct the Corcinch-HF pivotal clinical trial. The study is intended to demonstrate the safety and effectiveness of the Accucinch ventricular restoration system in patients with heart failure and reduced ejection fraction (HFrEF).
TORONTO – Once he’d enrolled in an entrepreneurial engineering course, third-year medical school student Gabriel Georges’ task was deceptively simple: come up with a device to meet an unmet medical need. Before long, Georges had pulled two other students with engineering and investor relations smarts into the project, developing a minimally invasive, long-term transcatheter heart pump that this month garnered financing from Canadian and U.S. investors.
Precardia Inc. received some good news from the U.S. FDA, which has granted the company's catheter-based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) breakthrough device designation. The device is intended to quickly reduce congestion in the venous system, known as cardiac preload, with an eye toward improving overall cardio-renal function.
PARIS – Fineheart SA, of Bordeaux, France, reported the success of a seven-day preclinical study to evaluate its Implantable Cardiac Output Management System (ICOMS), the first fully Intra-Ventricular Flow Accelerator synchronized to the native heartbeat to restore natural heart pumping capacity.
The U.S. FDA has given the greenlight to Eko Devices Inc.’s electrocardiogram (ECG)-based algorithm to aid in detecting patients with heart failure during the COVID-19 pandemic. The artificial intelligence (AI)-powered algorithm, which provides a quick way to screen for low ejection fraction, won FDA breakthrough status in December of 2019.
With new a FDA approval for a years-old type 2 diabetes drug, Astrazeneca plc's Farxiga (dapagliflozin) has become the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to be approved to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure patients with reduced ejection fraction, a measure of how much blood the left ventricle pumps out with each contraction.
