News

CardiacAssist Protek17 Arterial Cannula for TandemHeart pVAD

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...

Vascular closure devices have a definite niche in areas where they were not originally intended but have found frequent off-label use because of their utility.

Cardiac surgeons and cardiologists at the University of Maryland Heart Center are part of a multi-center clinical trial evaluating the efficacy of powering heart pumps through a skull-based...

Sorin Group has received 510(k) clearance for commercialization of Sorin Connect, Sorin Group’s perfusion electronic charting system. The new Sorin Connect perfusion electronic charting system...

Impella CP Abiomed 15,000 Patients United States 1,000 Global Patients

Abiomed Inc. reported that physicians have implanted more than 15,000 Impella pumps in U.S. patients requiring hemodynamic support. The 15,000th Impella procedure took place at Mercy General...

July 19, 2013 — The Mount Sinai Medical Center is the first medical center in New York City to offer the HeartMate II pocket controller, newly approved by the U.S. Food and Drug...

Abiomed’s Impella percutaneous left ventricular assist device (pLVAD) was recently deployed at Baylor Medical Center in McKinney, Texas, to treat country music singer Randy Travis.

Extracorporeal membrane oxygenation (ECMO), a procedure traditionally used during cardiac surgeries and in the intensive care unit (ICU) that functions as an artificial replacement for a patient's...

Synergy IC Circulatory Support System Circulite CE mark Trial

CircuLite Inc. announced that it has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE mark ...

VAD wireless power transfer system

Leviticus Cardio performed a successful animal surgical trial using its wireless coplanar energy transfer system (CET) for ventricular assist devices (VAD). The surgery was performed at Assaf...

There is a growing trend in the use of small, portable extracorporeal membrane oxygenation (ECMO) systems for hemodynamic support. In years past, ECMO systems were a tool of the operating room,...

Since the 1970s, intra-aortic balloon pumps (IABPs) have been the gold standard of minimally invasive hemodynamic support, but more recently developed percutaneous ventricular assist devices (pVAD...

March 13, 2013 — CircuLite Inc. announced it has received conditional approval from the U.S. Food and Drug Administration (FDA) for an investigational device exemption (IDE) for its lead product,...

My job as editor of DAIC is to help readers keep tabs on the latest in cardiovascular technology and trends. With collaboration from my Editorial Advisory Board, we developed a 2013...

December 19, 2012 — CardiacAssist Inc. announced it has received investigational device exemption (IDE) approval from the U.S. Food & Drug Administration (FDA) for a pivotal clinical study of...

Abiomed Inc. announced the U.S. Food and Drug Administration's (FDA) Circulatory System Devices Panel voted to retain Class III status for the temporary ventricular support devices within the non-...

 The U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the HeartWare Ventricular Assist System (VAS) designed as a bridge to cardiac transplantation.

FDA Intra-Aortic Balloon Pumps

November 8, 2012 — A U.S. Food and Drug Administration (FDA) advisory committee is meeting Dec. 5 to discuss how to classify and regulate...

Maquet Sensational Plus IABP

Maquet Cardiovascular received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE mark approval for its new Sensation Plus 7.5 French 40 cc...

Clinical Trial NIH NCI PET/CT Systems Standardization

The National Institutes of Health (NIH)/National Cancer Institute (NCI) has awarded a five-year research project grant (R01) to identify harmonized reconstruction parameters for each currently-...