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...

Thoratec, HeartMate II, ROADMAP
Thoratec Corp. announced results from the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management...
Protek Duo, VV ECLS, CE mark, CardiacAssist, veno-venous cannula
CardiacAssist Inc. announced that it received a Class 3 CE-mark for its Protek Duo veno-venous cannula. The Protek Duo is licensed for use as a single...
intraaortic balloon pumps, IABP, ventricular assist devices, VAD, cost effective
Maquet Cardiovascular USA announced publication of a manuscript comparing the clinical and economic impact of percutaneous ventricular assist devices (pVAD)...
expert consensus, SCAI, ACC, HFSA, STS, heart pumps, MCS devices
An expert consensus statement released by four leading cardiovascular societies provides new guidance on percutaneous mechanical circulatory support (MCS)...
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

expert consensus, SCAI, ACC, HFSA, STS, heart pumps, MCS devices
An expert consensus statement released by four leading cardiovascular societies provides new guidance on percutaneous mechanical circulatory support (MCS)...
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...

Video Center

There were several technology takeaway messages for the future of electrophysiology (EP) at the...
3 days 9 hours ago
The Heart Rhythm Society’s 36th Annual Scientific Sessions, May 13-16, 2015 in Boston, will offer...
2 weeks 8 hours ago
U.S. healthcare reform is largely being driven through adoption of new information technology (IT...
4 weeks 4 days ago
The webinar Maximize Your Clinical Imaging With a VNA Strategy will explain the changing face of medical imaging and data, and the challenges to...
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...