The Latest Cardiac and Vascular News
PALO ALTO, Calif., Sept. 22, 2022 /PRNewswire/ — DyAnsys, Inc., has announced that Primary Relief, a percutaneous electrical neurostimulation device, has been approved to treat pain following a cardiac surgery. The percutaneous electrical nerve stimulator (PENS) system can be used for up to three days for symptomatic relief of post-operative pain following […]
The LINQ II ICM is the first continuous, long-term cardiac monitor cleared by FDA for the pediatric patient population DUBLIN, Sept. 20, 2022 /PRNewswire/ — Medtronic plc ( NYSE:MDT), a global leader in healthcare technology, today announced the LINQ II™ Insertable Cardiac Monitor (ICM) system is the first-and-only ICM to receive 510(k) clearance by […]
Breakthrough Designation Reinforces Significant Unmet Need in Treatment of Small Vessel Coronary Arteries LOS GATOS, Calif., Sept. 19, 2022 /PRNewswire/ — Advanced NanoTherapies, Inc., a privately-held medical device company committed to solving vascular disease’s most significant challenges through the creative applications of nanotechnology, today announced the U.S. Food and Drug Administration (FDA) has […]
TAMPA, Fla., Sept. 17, 2022 /PRNewswire/ — The US FDA has granted an Investigational Device Exemption (IDE) approval for MagicTouch Sirolimus Coated Balloon (SCB) indicated for In-Stent Restenosis (ISR). US FDA’s IDE approval allows the MagicTouch SCB to be used in a pivotal clinical study to support safety and effectiveness of this combination product. The data generated […]
FDA Also Approves and Closes RECOVER III Post-Approval Study DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces two approvals from the U.S. Food and Drug Administration (FDA) related to clinical research of Impella heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients. The FDA has approved the on-label RECOVER IV randomized controlled […]
IRVINE, Calif., Sept. 15, 2022 /PRNewswire/ — Edwards Lifesciences Corporation ( NYSE: EW), today announced the company’s PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) has received FDA approval for the treatment of patients with degenerative mitral regurgitation (DMR). “Patients suffering with debilitating symptoms as a result of degenerative mitral regurgitation represent a […]
HALIFAX, Nova Scotia, Sept 12, 2022 – ABK Biomedical, Inc., an innovative medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces FDA 510(k) clearance of Easi-Vue embolic microspheres for the treatment of patients suffering from arteriovenous malformations and hypervascular tumors. Arteriovenous malformations (AVMs) […]
IRVINE, Calif., Sept. 12, 2022 /PRNewswire/ — Edwards Lifesciences ( NYSE: EW) today announced the launch of the SAPIEN 3 Ultra RESILIA valve, which incorporates Edwards’ breakthrough RESILIA tissue technology with the industry-leading SAPIEN 3 Ultra transcatheter aortic heart valve. The launch follows recent U.S. Food and Drug Administration (FDA) approval. RESILIA tissue is […]
This is the second Fast Track designation issued by the FDA for abelacimab Abelacimab is a dual-acting, once-monthly, fully human monoclonal antibody targeting both Factor XI and Factor XIa with high affinity and selectivity CAMBRIDGE, Mass., Sept. 08, 2022 (GLOBE NEWSWIRE) — Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for […]
US Arm of IMPACT II Study Will Ascertain Reduction of Esophageal Thermal Injury During Cardiac RF Ablation Procedures CHICAGO–(BUSINESS WIRE)–The US Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to Attune Medical to evaluate the company’s ensoETM in the reduction of esophageal thermal injury during cardiac radiofrequency ablation […]
