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...
CircuLite Inc. announced that it has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE mark ...
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...
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.
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...
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-...
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 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 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...
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...
July 3, 2012 — Patients unable to breathe because of acute lung failure or an obstructed airway need another way to get oxygen to their blood—and fast—to avoid cardiac arrest and brain injury. A...
May 21, 2012 — Minnetronix announced the exclusive licensing rights of Penn State Research Foundation’s wireless energy transmission technology to power circulatory assist...
May 16, 2012 — Maquet Cardiovascular LLC announced this week that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Mega 7.5 Fr. 30 cc and 40 cc...
April 23, 2012 - CircuLite Inc. announced that updated clinical data related to the Synergy miniature ventricular support system was presented in two oral presentations and one poster session at...
April 17, 2012 – SynCardia Systems Inc., manufacturer of the world’s first and only FDA-, Health Canada- and CE-approved Total Artificial Heart, announced that the U.S. Food and Drug...
April 12, 2012 - Abiomed Inc., a provider of heart support technologies, announced it has received CE marking approval in the European Union to market the Impella cVAD device, a new...
April 9, 2012 — Thoratec and the U.S. Food and Drug Adminstration (FDA) announced a recent Class 1 recall of the HeartMate II left ventricular assist device (LVAD) because detachment of the bend...
March 26, 2012 — Maquet announced positive long-term mortality results from the Balloon Pump-Assisted Coronary Intervention Study (BCIS-1), which evaluated the effect on major complications and...
Jack Miller, 62, is probably the only politician in America who smiles when people call him “heartless.” Four months ago, doctors at Virginia Commonwealth University (VCU) Medical Center in...
March 5, 2012 — SynCardia Systems Inc., manufacturer of the world’s first and only U.S. Food and Drug Administration (FDA), Health Canada and Conformité Européenne (CE) approved Total Artificial...
Jarvik Heart Inc. announced conditional U.S. Food and Drug Administration (FDA) approval of its pivotal trial for evaluation of the Jarvik 2000 heart for destination therapy (DT). Use of the...
Teleflex Inc. announced a new agreement with HealthTrust Purchasing Group L.P. (HealthTrust), for its Arrow Intra-Aortic Balloon Pump and Catheter products. The new agreement begins March 1, 2012...
February 22, 2012 — HeartWare International Inc. announced that a U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel will review the premarket approval (PMA) application for...
February 16, 2012 — Few hospitals have as much experience with the Berlin Heart pediatric ventricular assist device (VAD) as DMC Children's Hospital of Michigan. This is why the U.S. Food and Drug...
February 2, 2012 — Abiomed Inc. announced that initial clinical data from the safety study for Symphony was presented by Renzo Cecere, M.D., FRCSC, FACS, associate professor of surgery at McGill...
January 27, 2012 — A miniature, battery-free, wireless, cardiac implant being developed by a University of Michigan researcher and the Ann Arbor, Mich., company Integrated Sensing Systems, Inc. (...
January 11, 2012 — HeartWare International, Inc. and Dualis MedTech GmbH, a subsidiary of AVRA Surgical, Inc., announced an agreement to develop ventricular assist devices with wireless,...
December 19, 2011— Newborns, toddlers and teens who suffer from heart failure and need heart transplantation to survive just got a life-saving pediatric heart pump that buys time and allows them...
November 18, 2011 —The Berlin Heart Group announced today that clinical trial data were presented this morning at the “Scientific Sessions 2011” annual meeting of the ...
November 11, 2011 — Maquet Cardiovascular announced U.S. Food and Drug Administration (FDA) 510(k) clearance and CE mark for its new Cardiosave intra-aortic balloon pump (IABP). The announcement...
November 9, 2011 – Abiomed, a provider of heart support technologies, announced results of an economic study at the annual 2011 Transcatheter Cardiovascular Therapeutics (TCT) conference. The...
November 8, 2011 – Abiomed, a provider of heart support technologies, announced results of an economic study at the annual 2011 Transcatheter Cardiovascular Therapeutics (TCT) conference. The...
October 17, 2011 — Maquet Cardiovascular announced it has signed a three-year, dual-source contract with Premier Healthcare Alliance to provide intra-aortic balloon pumps (IABP) to the Premier...
October 3, 2011 – Maquet Cardiovascular has signed a definitive agreement to acquire Atrium Medical Corp. for $680 million. Atrium is a medical device technologies developer for...
September 20, 2011 — Maquet Cardiovascular announced it has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Sensation Plus 50 cc 8 French intra-aortic...
September 8, 2011 – SynCardia Systems, manufacturer of the SynCardia temporary Total Artificial Heart, announced that Texas Children's Hospital in Houston has discharged its first pediatric Total...
September 1, 2011 – Mechanical pumps to give failing hearts a boost were originally developed as temporary measures for patients awaiting a heart transplant. But as the technology has improved,...
August 29, 2011 — Recent data suggest post-operative outcomes of severe heart failure patients bridged short-term ventricular assist devices (VADs) to urgent heart transplantation are...
August 12, 2011 — SynCardia Systems Inc., manufacturer of the temporary Total Artificial Heart (TAH). said Aug. 2, Papworth Hospital in Cambridge discharged the United Kingdom's first TAH patient...
August 3, 2011 — Texas Children's Hospital (TCH) is the nation's first pediatric hospital to both surgically implant and later explant a mechanical ventricular assist device (VAD) inside the chest...
August 2, 2011 – WorldHeart, which is developing ventricular assist devices designed for adults, children and infants suffering from heart failure, announced that it will cease its efforts to...
July 27, 2011 – A special panel convened July 21 in Gaithersburg, Md., to review the results of the Excor pediatric ventricular assist device (VAD) investigational device exemption (IDE) clinical...
July 19, 2011 — Terumo Heart Inc., a wholly owned subsidiary of Terumo Corp., today announced that a patient implanted with the DuraHeart left ventricular assist system (LVAS) has surpassed five...
July 19, 2011 — An article published in the July issue of the Journal of Heart and Lung Transplantation reports the first use of the Freedom portable driver with a Total Artificial Heart...
July 13, 2011 – The TandemHeart circulatory support system has been granted expanded reimbursement coverage by NHIC Corp., the medicare administrative contractor (MAC) serving over 1.3 million...
June 30, 2011 — Results of a clinical research study at Sharp Memorial Hospital indicate that patients 70 years of age or older have good functional recovery, survival and quality of life at two...
June 15, 2011 – The U.S. Food and Drug Administration (FDA) said Maquet Datascope Corp. has issued a class I recall for its System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs)...
June 14, 2011 – An initial animal study of a next-generation transcutaneous C-Pulse Heart Assist System has been completed. The system is made by Sunshine Heart Inc., a global medical device company...
May 10, 2011 – The Impella percutaneously deployed ventricular assist device showed an overall average hospital charge savings when compared to the standard-of-care intra-aortic balloon pump (IABP)....
May 3, 2011 – The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to Maquet Cardiovascular’s Cardiohelp system as a cardiac and/or respiratory assist device for up to six hours....
April 19, 2011 – Promising new devices for mechanical circulatory support of children with heart defects or heart failure, and related research, will be revealed this week at the International...
April 13, 2011 – The American College of Cardiology Foundation (ACCF), American Heart Association (AHA) and the Heart Failure Society of America (HFSA) have released results of a recent survey to...
A transcatheter ventricular assist device performed better than intra-aortic balloon pumps (IABP), with a 21 percent reduction in major adverse events at 90 days.
March 28, 2011 – The Therapeutic Goods Administration (TGA) of Australia has approved the HeartWare Ventricular Assist System for listing on the Australian Register of Therapeutic Goods (ARTG).
March 11, 2011 – Texas Children's has become the world's first pediatric hospital to complete the first phase of certification to implant the SynCardia temporary Total Artificial Heart. The...
February 17, 2011 – On Jan. 15, after 864 days of life with an artificial heart, Charles Okeke received a dual heart and kidney transplant at the Mayo Clinic Hospital in Phoenix. Okeke had been...
January 27, 2011 – The U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) Supplement allowing more patients to participate in the ADVANCE trial. The...
January 26, 2011 - The University of Michigan Cardiovascular Center and the University of Pittsburgh have been awarded $13.3 million to explore the potential benefits of heart devices for the...
January 13, 2011 – HeartWare International has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration for its ventricular assist system. The system acts as a...
January 3, 2011 – Arrow International, a division of Teleflex Medical, issued a class I recall, advising customers to immediately discontinue use of its Ultra 8 French intra-aortic balloon pump (...
December 7, 2010 – A study comparing a transcatheter ventricular assist device (VAD) to intra-aortic balloon pumps (IABP) has been completed after interim analysis determined the primary endpoint...
