News

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...

Procyrion Aortix Ventricular Assist Device Hemodynamic Support Heart Failure

Start-up company Procyrion Inc. is developing a catheter-deployed circulatory assist device intended for long-...

The Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) 2013 offers many new insights about the latest cardiovascular technologies and treatment techniques. These...

The National Cheng Kung University Heart Science and Medical Devices Research Center (NCKU HSDMRC) and the Division of Cardiothoracic Surgery, Department of Surgery, Duke University, Durham, NC,...

hemodynamic support systems heat failure treatments heartware circulite VAD

HeartWare International Inc. has acquired CircuLite, Inc., a developer of the Synergy Circulatory Support System, which is designed to treat less sick, ambulatory, chronic ...

ventricular assist devices vad heart failure sunshine minnetronix c-pulse VAD

Sunshine Heart Inc. announced its collaboration with Minnetronix for a transcutaneous energy transfer (TET) system to power the company's fully-implantable C-Pulse Heart Assist ...

Sunshine Heart Inc. has launched a website dedicated to providing information to patients suffering from moderate to severe heart...

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-...

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...

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...

June 14, 2012 — Abiomed Inc. said today it received Health Canada approval to market the Impella cVAD (...

May 30, 2012 — MAQUET Cardiopulmonary, a business unit of MAQUET Cardiovascular and a leader in extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems, announced...

 

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 percutaneous...

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...

Symphony.

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 5, 2011 — Heart failure circulatory support system maker Thoratec Corp. announced it acquired the medical business of ventricular assist device (VAD) maker Levitronix Medical. The company...

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...