The Latest Cardiac and Vascular News
RIDGEFIELD, Conn. and INDIANAPOLIS, Jan. 11, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) which is being investigated as a potential new treatment to reduce the risk of cardiovascular death and hospitalization for heart […]
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 […]
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 […]
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. […]
– 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 […]
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 […]
LAKE OSWEGO, Ore., Dec. 16, 2020 /PRNewswire/ — BIOTRONIK today announced FDA clearance and availability of the Vital Data Sensor, which identifies body temperature increases potentially associated with fever, in the new BIOMONITOR IIIm injectable cardiac monitor (ICM), as shown in a published case […]
MASON, Ohio–(BUSINESS WIRE)–Genetesis, Inc. announced today that its flagship product, CardioFlux®, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute […]
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria™ biopolymer mitral surgical heart valve. The company anticipates the […]
– SoniVie Acquires New Intellectual Property and Other Assets from Cardiosonic Moving TIVUS into New Therapeutic Areas Beyond Pulmonary Hypertension – TEL AVIV, Israel, Dec. 09, 2020 (GLOBE NEWSWIRE) — SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular […]
