News

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 heart as a bridge to transplantation...

Surgical aortic valve replacement generally improves patients’ symptoms and prolongs survival. However, the perceived risk of surgical aortic valve replacement in patients over 80 may result in...

June 23, 2014 — Edwards Lifesciences Corp. announced that three-year clinical outcomes of its Edwards Intuity valve platform demonstrated improved cardiac and valvular performance, as well as...

June 23, 2014 — Researchers have announced the results of a four-year study that used 3-D echocardiography to examine the role of mid left atrial cross sectional area (LACSA) as a risk factor for...

ClearFlow PleuraFlow Active Clearance Technology

Distinguished physicians from leading cardiac surgery centers gathered at an educational symposium to share their experiences with a new-generation blood evacuation system for use following...

Medtronic 3f Enable Aortic Bioprosthesis Valve Repair Cardiovascular Surgery

Medtronic Inc. announced five-year follow-up data demonstrating the safety and performance of the Medtronic 3f Enable Aortic Bioprosthesis — the world's first commercially available sutureless...

Strokes kill nearly 130,000 Americans every year, according to the Centers for Disease Control and Prevention. Because approximately 30 percent of strokes are caused by blockages in the carotid...

3-d pronting, 3D printing

The FDA has recognized 3-D printing technology now exists to print medical devices and is gathering information regarding technical assessments that should be considered when it will inevitably...

IABP, Datascope, Maquet, FDA recall

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...

Advanced Visualization Artificial Hear Heart Repair Arizona State University

An Arizona State University research group and medical professionals at Phoenix Children’s Hospital are achieving some firsts in the history of artificial heart implantation.

Manny Villafana, chairman and CEO of Kips Bay Medical Inc., announced that on Jan. 14, 2014, the first commercial implant of the company's eSVS Mesh in Austria was performed at the Medical...

April 23, 2014 — The PROCEED II heart transplant U.S. Food and Drug Administration (FDA) pivotal trial results using the Organ Care System (OCS) Heart platform were announced at the International...

April 16, 2014 — Covidien announced it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline embolization device and Alligator retrieval device, where...

April 10, 2014 — The largest single-center study of patients implanted with a total artificial heart found the device may help patients in severe heart failure survive until they can receive a...

InspireMD Inc. has enrolled the first patient into the CARENET (CARotid Embolic protection study using microNET) multi-center European...

Surgeons in France have successfully replaced the aortic valve in two patients without opening the chest during surgery....

PVAD, percutaneous VAD, hemodynamic support, aortix

Percutaneous ventricular assist (pVAD) devices offer more hemodynamic support than the 40-year-old gold standard of intra-aortic balloon pumps (IABPs), but their cost and...

Cath Lab Clinical Trial Study Cardiovascular Surgery

National Institutes of Health researchers have identified a biological pathway that contributes to the high rate of vein graft failure following ...

On-X Life Technologies On-X Plus 1.5 Aortic Heart Valve Repair Cardiovascular

On-X Life Technologies Inc.  received CE marking for an expanded labeling claim of its On-X Prosthetic Heart Valve. The company may market its ...

Edwards Lifesciences Embol-X Glide Protection System Embolic Device Surgery

The U.S. Food and Drug Administration (FDA) issued a Class I Recall of Edwards Lifesciences LLC’s Embol-X Glide ...