News

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-...

Synergy Circulatory Support System CircuLite Inc. Ventricular Assist Device

October 1, 2012 — CircuLite Inc. announced that the latest data from patients enrolled in the company’s CE mark trial of the Synergy Circulatory Support System strengthened prior findings...

September 18, 2012 — Abiomed Inc. announced it received confirmation from the American Medical Association (AMA) of three new Category I Current Procedure Terminology (CPT) codes for Impella...

CircuLite Synenery Circulatory Support System VAD

CircuLite Inc. announced that it has received CE marking approval for the Synergy Circulatory Support System, a micro-pump designed to halt the progression of heart failure. By working with the...

Abiomed Impella CP VAD

Abiomed Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new percutaneous, catheter-based Impella ventricular assist device (VAD) providing...

September 11, 2012 — Primary results from an ongoing trial by Maquet Cardiovascular using intra-aortic balloon pumps (IABP...

September 10, 2012 — Maquet Cardiovascular LLC announced 30-day results from the large, randomized, multicenter intra-aortic...

August 17, 2012 — Jarvik Heart Inc., a privately held company that develops and manufactures cardiac assist devices, announced U.S. Food and Drug Administration (FDA) approval of its pivotal trial...

August 14, 2012 — Berlin Heart announced that a study recently published in the New England Journal of Medicine (NEJM) concluded that survival using the Excor pediatric...

Aug. 8, 2012 — The Berlin Heart Group said the U.S. Food and Drug Administration (FDA) has granted approval for its post approval study, a condition of the humanitarian device...