The Latest Cardiac and Vascular News
MARLBOROUGH, Mass., May 6, 2019 /PRNewswire/ — Boston Scientific (NYSE: BSX) announced today that the U.S Food and Drug Administration (FDA) has approved the VICI VENOUS STENT™ System for the treatment of iliofemoral venous obstructive disease, which occurs when the flow of blood through the veins located deep in the pelvic region becomes blocked […]
SILVER SPRING, Md., May 6, 2019 /PRNewswire/ — On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin‑mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the […]
TAMPA, Florida, May 2, 2019 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR). In-stent restenosis (ISR) is the gradual re-narrowing of a stented coronary artery lesion, due to […]
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial. The prospective, multi-center, two-arm trial plans to enroll 668 patients undergoing treatment for a STEMI heart attack. Half the patients will be randomized to receive […]
DUBLIN – May 2, 2019 – Medtronic plc (NYSE:MDT) today announced that the company has received U.S. Food and Drug Administration (FDA) approval for the CareLink SmartSync(TM) Device Manager. With the introduction of SmartSync, physicians will now be able to use an Apple® iPad® to program and manage data from Medtronic’s BlueSync-enabled […]
BOSTON, April 30, 2019 /PRNewswire/ — Biofourmis announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its RhythmAnalyticsTM platform, a cloud-based software for automated interpretation of cardiac arrhythmias. It uses an enhanced deep-learning technique to detect over 15 types of cardiac arrhythmias along with beat-by-beat morphology computation which […]
DUBLIN – May 1, 2019 – Medtronic plc (NYSE:MDT) announced it has received U.S. Food and Drug Administration (FDA) approval for the Attain Stability(TM) Quad MRI SureScan(TM) left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead is the only active-fixation left […]
ST. PAUL, Minn.–(BUSINESS WIRE)–VivaQuant, a digital health company with powerful technology to accurately and efficiently identify and report cardiac arrhythmias, has received FDA clearance for its RX-1 wearable device. RX-1 continuously monitors a patient’s ECG as they go about their normal daily activities, identifies arrhythmias, and communicates the information to […]
NEW HOPE, Pa., April 24, 2019 (GLOBE NEWSWIRE) — Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing advanced therapeutic solutions to address major unmet healthcare needs, announced today that it has secured Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its Virtue® Sirolimus-Eluting […]
MARLBOROUGH, Mass., April 23, 2019 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the LOTUS Edge™ Aortic Valve System. Delivered via a minimally-invasive procedure, this transcatheter aortic valve replacement (TAVR) technology is approved for patients with severe aortic stenosis who are considered at […]
