News

September 5, 2014 — CardiacAssist announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Protek Duo veno‐venous cannula. The Protek Duo is...

August 29, 2014 — CardiacAssist announced it has received a Class 2 medical device license from Health Canada for its new Protek Duo veno-venous cannula. The Protek Duo is licensed for use as a...

MYDICAR Celladon Corp. Clinical Trial Heart Failure Treatments LVADs

Celladon Corp. announced that the first patient has been dosed in a clinical trial titled "Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients with Heart Failure...

SynCardia Total Artificial Heart SynHall Valves FDA approval

SynCardia Systems Inc. received approval in July from the U.S. Federal Drug Administration (FDA) for the SynCardia temporary Total Artificial Heart with SynHall valves, giving the company control...

August 7, 2014 — The Berlin Heart Group announced they have completed enrollment in their post-approval study, the only condition of the humanitarian device exemption (HDE) approval that...

SynCardia Total Artificial Heart Implant VAD Heart Failure Treatments

For the first time, cardiac surgeons, medical professionals and the public can watch the implantation of the SynCardia temporary Total Artificial Heart in a peer reviewed case report paper and...

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...

Thoratec Corp. has acquired Apica Cardiovascular Ltd. for an upfront cash payment of $35 million and potential future clinical and sales milestones of up to $40 million. 

Watchman, LAA occluder

Interventional thought leaders at the American College of Cardiology (ACC) 2014 meeting shared their predictions about the cutting-edge technologies emerging today that will become commonplace in...

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...

HeartWare Ltd. Ventricular Assist Device Correction Batteries

HeartWare Intl. Inc. issued a voluntary Urgent Medical Device Correction related to all HeartWare Ventricular Assist System batteries, product codes 1650 and 1650-DE. 

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.

heartware lvads vanderbilt heart heartmate

April 25, 2014 — Vanderbilt Heart and Vascular Institute (VHVI) was the first facility in Tennessee to implant the miniaturized HeartWare HVAD pump through a minimally invasive approach known as a...

Allison Morgan was in pretty bad shape when the medical helicopter touched down on the rooftop helipad of the University of Alabama at Birmingham Hospital (UAB).

ICD Heart Failure Treatments VAD California Boston Scientific

Three weeks after delivering her first child, Amanda began to suffer from extreme fatigue, headaches, a tight chest and stomach pain. An initial diagnosis of pneumonia changed for the worse:...

April 18, 2014 — New research presented at the 34th annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) demonstrated the CorMatrix particulate extracellular...

April 14, 2014 — CardiacAssist announced it has received a Class 4 medical device license for its TandemHeart system from Health Canada. The TandemHeart system is now licensed to provide up to 10...

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...

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...

Thoratec HeartMate II LVAS Pocket System Controller Heart Failure Devices VAD

Thoratec Corp. initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II LVAS Pocket System Controller. The following...