The Latest Cardiac and Vascular News
Expansion includes adolescent patients, as young as 12 years of age, who can benefit from cryo nerve block therapy during surgical procedures involving the chest wall. MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced that […]
CE marking allows the company to market its total artificial heart in the EU as a bridge to transplant Virtual press conference scheduled on January 6, 2021 PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an […]
DRIVEWIRE™ provides efficient access in difficult neuro and peripheral vascular procedures YOKNEAM, Israel & MIAMI–(BUSINESS WIRE)–Rapid Medical, a company focused on the development of the first class of responsive, adjustable neurovascular devices, announces the FDA clearance of DRIVEWIRE, a novel guidewire with a steerable distal tip that handles complex anatomical […]
TricValve® made in Europe VIENNA, Dec. 22, 2020 /PRNewswire/ — P+F Products + Features GmbH has been granted designation as a Breakthrough Device for the company’s lead product, the TricValve® Transcatheter Bicval Valves System by the U.S. Food & Drug Administration on December 15th 2020. The TricValve® is a system of two self-expanding biological valves for […]
New Software Version for Vantage Orian 1.5T Also Offers Solution to Help Clinicians Image and Quantify Fatty Liver Disease TUSTIN, Calif.–(BUSINESS WIRE)–Hospitals and institutions are continually looking for ways to improve diagnostic imaging throughput, especially in today’s environment where disinfection of systems and rooms in between patients is crucial. Now, […]
– Abbott’s HeartMate 3™ heart pump approved for use for pediatric patients battling advanced heart failure – This life-saving technology provides new treatment option for underserved population ABBOTT PARK, Ill., Dec. 17, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved updated labeling for the […]
SCHAFFHAUSEN, Switzerland, Dec. 18, 2020 /PRNewswire/ — Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH). PAH affects hundreds of thousands in the U.S. and globally and […]
TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed […]
– Large, Randomized Controlled ADVENT Trial Designed to Establish New Gold Standard for AF Ablation – MENLO PARK, Calif., Dec. 17, 2020 /PRNewswire/ – FARAPULSE Inc. (“FARAPULSE” or “the Company”) today announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT […]
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF) Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of […]
