News

ECRI Institute, review, Impella RP, Abiomed

ECRI Institute recently reviewed published data on Abiomed’s Impella RP (Right Percutaneous) transcatheter ventricular assist device (VAD). The institute said the device provides immediate...

UH Case Medical Center, Impella RP, first in Ohio, Abiomed, Mobile Learning Lab

University Hospitals Case Medical Center physicians in the Harrington Heart & Vascular Institute were the first in Ohio to implant a new device to treat right ventricular heart disease.

Beaumont Hospital Royal Oak, Impella RP, right-side heart failure, Abiomed

Beaumont Hospital, Royal Oak is one of the first centers in the United States to use a new minimally invasive heart pump designed to provide temporary support for patients with severe right-side...

Thoratec, HeartMate II, ROADMAP

Thoratec Corp. announced results from the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients...

Protek Duo, VV ECLS, CE mark, CardiacAssist, veno-venous cannula

CardiacAssist Inc. announced that it received a Class 3 CE-mark for its Protek Duo veno-venous cannula. The Protek Duo is licensed for use as a single cannula for both venous drainage and...

intraaortic balloon pumps, IABP, ventricular assist devices, VAD, cost effective

Maquet Cardiovascular USA announced publication of a manuscript comparing the clinical and economic impact of percutaneous ventricular assist devices (pVAD) with intra-aortic balloon pumps (IABP)...

expert consensus, SCAI, ACC, HFSA, STS, heart pumps, MCS devices

An expert consensus statement released by four leading cardiovascular societies provides new guidance on percutaneous mechanical circulatory support (MCS) devices for treatment of heart failure....

SynCardia, Total Artificial Heart, 50cc, FDA, investigational study

SynCardia Systems Inc. has received U.S. Food and Drug Administration (FDA) approval to conduct an Investigational Device Exemption (IDE) clinical study on the effective use of its 50cc SynCardia...

Impella, FDA, high risk PCI, abiomed

The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) clearance for Abiomed’s Impella 2.5 heart pump during elective and urgent high-risk percutaneous coronary...

Artificial Heart, Ventricular Assist Device, Heart failure, SynCardia

SynCardia Systems Inc. has received U.S. Food and Drug Administration (FDA) approval to conduct a clinical study of the effectiveness of the SynCardia temporary Total Artificial Heart for...

Thoratec, HeartMate III, VAD, NewYork Presbyterian, trial, ventricular assist

NewYork-Presbyterian Hospital/Columbia University Medical Center is one of a select group of medical centers participating in a clinical trial of a new device for advanced heart failure patients,...

CardiacAssist Inc. announced that the first Protek Duo veno-venous extracorporeal life support (VV ECLS) kit was utilized Sept. 24, at Memorial Hermann Hospital in Houston.

Clinical trial results by Recover Right revealed a survival rate of 73 percent in the total patient population. Recover Right was an FDA-approved, prospective, multicenter, single arm study...

St. Vincent Implant Thoratec Corp. HeartMate III VAD

St. Vincent Heart Center officials announced that the faith-based hospital is the second in the nation to implant the new investigational “heart pump.”

heartmate III, tohratec, heart failure, heart failure treatment

Thoratec Corporation announced that it has begun to enroll patients in the HeartMate III U.S. clinical trial. 

VADs Gain Popularity Artificial Hearts Remain Ideal GlobalData

Robert Littlefield, MSc, GlobalData's senior analyst covering Medical Devices, said: “Since the first implantation of the Jarvik 7 in 1982, artificial heart devices have evolved significantly...

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...