Ventricular Assist Devices (VAD)

Impella, FDA, high risk PCI

The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) clearance for Abiomed’s Impella 2.5 heart pump during elective and urgent high-risk percutaneous coronary intervention (PCI) procedures.

July 18, 2014 — The Freedom portable driver has received U.S. Food and Drug Administration (FDA) approval for use with the SynCardia temporary total artificial heart as a bridge to transplantation in cardiac transplant candidates who are clinicall...

IABP, recall, datascope, maquet

Datascope Corp./Maquet initiated a voluntary worldwide field correction of some of its intra-aortic balloon pumps (IABPs) due to a potential mechanical failure of the fan assembly associated with the power supply. All customers that may have an IA...

CardiacAssist launched the Protek17 Arterial Cannula, a key component of the TandemHeart temporary circulatory support platform used to rest the heart and circulate blood for patients with severe cardiac dysfunction. Protek17 is designed for impro...

Impella, FDA, high risk PCI, abiomed
The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) clearance for Abiomed’s Impella 2.5 heart pump during elective and urgent...
Artificial Heart, Ventricular Assist Device, Heart failure, SynCardia
SynCardia Systems Inc. has received U.S. Food and Drug Administration (FDA) approval to conduct a clinical study of the effectiveness of the SynCardia...
Thoratec, HeartMate III, VAD, NewYork Presbyterian, trial, ventricular assist
NewYork-Presbyterian Hospital/Columbia University Medical Center is one of a select group of medical centers participating in a clinical trial of a new device...
CardiacAssist Inc. announced that the first Protek Duo veno-venous extracorporeal life support (VV ECLS) kit was utilized Sept. 24, at Memorial Hermann...
Impella, FDA, high risk PCI, abiomed
Abiomed’s Impella 2.5 heart pump has gained an additional FDA vindication for use during elective and urgent high-risk percutaneous
CardiacAssist's Protek Duo veno‐venous cannula is intended for use as a single cannula for both venous drainage and reinfusion of...
SynCardia SynHall valves, use in the SynCardia Heart, are of the same design, materials and nearly identical manufacturing processes as the...
The Freedom portable driver is U.S. Food and Drug Administration (FDA)-approved for use with the SynCardia temporary total artificial heart...

Articles

Impella, FDA, high risk PCI, abiomed
The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) clearance for Abiomed’s Impella 2.5 heart pump during elective and urgent...
Clinical trial results by Recover Right revealed a survival rate of 73 percent in the total patient population. Recover Right was an FDA-approved, prospective...
VADs Gain Popularity Artificial Hearts Remain Ideal GlobalData
Robert Littlefield, MSc, GlobalData's senior analyst covering Medical Devices, said: “Since the first implantation of the Jarvik 7 in 1982, artificial...
Syncardiac, driver, artificial heart
July 18, 2014 — The Freedom portable driver has received U.S. Food and Drug Administration (FDA) approval for use with the SynCardia temporary total artificial...

Video Center

The biggest technology news coming out of the 2015 American College of Cardiology (ACC) annual...
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It’s been no secret that the American healthcare system needed to change to survive economically...
6 weeks 3 days ago
The silence is deafening. And since radiology associations, physician groups and vendors have yet...
8 weeks 3 days ago
Centricity, webinar, ZFV, ZFP, viewer, remote viewing system, enterprise
Healthcare organizations are demanding more capabilities for image viewers accessed by clinicians. Zero footprint (ZFP) viewers provide imaging tools from...
The webinar "State of the Art in MRI Pediatric Brain Perfusion Imaging" educates participants about the state of the art clinical and emerging translational...
This webinar discusses why contemporary adult cardiac interventions require significant ionizing radiation with potential health risks to both the patient and...