Industry Press Releases

Jan 9, 2020 | Industry Press Releases
FDA Grants Breakthrough Device Designation To Reflow Medical’s Temporary Spur Stent System

Reflow Medical announces that the Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA).

Jan 7, 2020 | Industry Press Releases
FDA Approves Less Invasive Surgical Approach For Abbott’s Heart Pump To Help Patients Avoid Open Heart Surgery

Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) approval of a new alternative surgical technique for Abbott’s HeartMate 3 heart pump that will allow more advanced heart failure patients to avoid open heart surgery.

Dec 23, 2019 | Industry Press Releases
FDA approves first generics of Eliquis

The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Dec 13, 2019 | Industry Press Releases
FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher.

Dec 10, 2019 | Industry Press Releases
First Patient Enrolled in PROMISE II U.S. Pivotal Study of LimFlow System to Treat Chronic Limb-Threatening Ischemia

LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the first patient has been treated in its PROMISE II U.S. pivotal trial of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System.

Dec 2, 2019 | Industry Press Releases
CryoLife Receives CE Mark for E-nya Thoracic Stent Graft

CryoLife, Inc. a leading cardiac and vascular surgery company focused on aortic disease, announced today it has received CE Mark for the E-nya thoracic stent graft system for the minimally invasive repair of lesions of the descending thoracic aorta, including thoracic aortic aneurysms and dissections.

Nov 27, 2019 | Industry Press Releases
Medtronic Drug-Coated Balloon Receives U.S. FDA Approval to Treat Arteriovenous Fistula Lesions

Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the IN.PACT™ AV drug-coated balloon (DCB), a paclitaxel-coated balloon indicated for the treatment of failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis.

Nov 19, 2019 | Industry Press Releases
Update On Device Failure Associated with Getinge’s Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i.

Nov 14, 2019 | Industry Press Releases
Clinical Review Demonstrates Cost-Effectiveness of Impella in High-Risk PCI and Cardiogenic Shock

To mark the five year anniversary of the study by Stretch, et al., on cost and outcomes trends for short-term mechanical circulatory support, Abiomed announces a comprehensive publication review of cost and comparative effectiveness of Impella in high-risk PCI and cardiogenic shock.

Nov 5, 2019 | Industry Press Releases
Opsens Announces Entry Into Structural Heart Market

Opsens Inc. announces today it is expanding its medical device business into the structural cardiology space and will accelerate development activities of products that reach beyond its current coronary and peripheral applications.