FDA approves HeartMate II mechanical heart pump for heart-failure patients

NEW YORK (April 25, 2008) -- Heart failure patients at NewYork-Presbyterian Hospital/Columbia University Medical Center were among the first to be implanted with the HeartMate II LVAS (Left Ventricular Assist System) -- a miniature mechanical pump that helps weak hearts pump blood -- that has now ...

Thoratec Announces Unanimous FDA Advisory Panel Recommendation for Approval of HeartMate II(R) for Bridge-to-Transplantation

PLEASANTON, Calif., Nov. 30 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR ), a world leader in products to treat cardiovascular disease, said today that the FDA Circulatory System Devices Advisory Panel has recommended unanimously that the agency approve, with conditions, the c...

US Patient Implanted With HeartMate II, Leaves ICU

HearMate II is yet to gain approval from the Food and Drug Administration (FDA), but the Barnes-Jewish Hospital in Missouri has implanted it in Wilson Guthrie, a 61-year-old man from Kansas, suffering from end-stage heart failure. He has since left for home, with that experimental heart-as...

Thoratec Corporation and HeartWare International, Inc. Announce Termination of Proposed Transaction

...he Thoratec(R) VAD (Ventricular Assist Device) and heartmate LVAS, with more than 13,000 devices implanted in p....itcmed.com Thoratec, the Thoratec logo, heartmate and heartmate II are registered trademarks of Thoratec Corporati...

First heart patients implanted with next-generation mechanical heart pump

... at NewYork-Presbyterian/Columbia leading to the FDA approval of Thoratec's heartmate and heartmate II. The DuraHeart is considered a third-generation device, with unique feat...

Thoratec Announces Appointment of Paul LaViolette to Board of Directors

...w.itcmed.com . Thoratec, the Thoratec logo, heartmate and heartmate II are registered trademarks of Thoratec Corporati...nt in and timing of clinical trials, including the heartmate II, the effects of FDA regulatory requirements and...

Thoratec and HeartWare Receive Request for Additional Information From Federal Trade Commission

...thoratec.com or http://www.itcmed.com . Thoratec, the Thoratec logo, heartmate and heartmate II are registered trademarks of Thoratec Corporation, and IVAD is a tradema...

Thoratec Announces Definitive Agreement to Acquire HeartWare International For US$282 Million;

...utcomes and clinician enthusiasm realized with the heartmate II. We believe that combining the strengths of th...ally approved cardiac assist devices including the heartmate II(R) LVAS (Left Ventricular Assist System), which...he Thoratec(R) VAD (Ventricular Assist Device) and heartmate LVAS with more than 12,000 devices implanted in pa...

Thoratec Reports 34 Percent Increase in 2008 Revenues

...ed by the successful U.S. commercial launch of our heartmate II(R) LVAS (Left Ventricular Assist System) for br...continue to see positive clinical results with the heartmate II and better than expected adoption of the device...outcomes." The company said it added 12 new heartmate II centers during the fourth quarter of 2008, endi...

Thoratec Reports 44 Percent Increase in Second Quarter Revenues;

...NCE DRIVEN BY SUCCESSFUL U.S. COMMERCIAL LAUNCH OF heartmate II(R) FOR BRIDGE-TO-TRANSPLANT...nters and benefited from favorable pricing for the heartmate II. In addition, we are seeing continued strong adoption of the heartmate II in Europe," he added. Burbach said that the c...

HeartMate in Medical Technology

Thoratec Says Interim Data Analysis Demonstrates Statistical Superiority for the HeartMate II(R) in Destination Therapy Trial

PLEASANTON, Calif., Dec. 4 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR ), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that a pre-specified interim analysis of data from its HeartMate II Destinati...

Thoratec Announces FDA Approval of HeartMate II(R) for Bridge-To-Transplantation

COMPANY WILL INITIATE COMMERCIAL LAUNCH PROGRAM TO ADD NEW CENTERS AND TO INCREASE AWARENESS AMONG CARDIOLOGISTS PLEASANTON, Calif., April 21 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR ), a world leader in device-based mechanical circulatory support therapies ...

First U.S. Patient to Receive New Heart-Assist Device Doing Well After Surgery at University of Michigan

...ical trials of heart-assist devices, including the heartmate II, which in April received approval from the U.S....rgery of a heart transplant. Devices such as the heartmate II and its predecessor heartmate XVE, and potentially the DuraHeart, may become sub...

HeartMate in Medical Products

HeartMate II

Description:... The heartmate II Left Ventricular Assist System (LVAS) is a small, quiet, next-generation...and quality of life. Through the rotary action of a single-moving part, the heartmate II LVAS can achieve long-term full circulatory support by pumping blood fro...
Company:Thoratec

HeartMate LVAS

Description:... There are two versions of the heartmate Left Ventricular Assist System (LVAS): the Vented ...tives when conventional drug therapies failed. The heartmate provides a lifesaving alternative for these patien...portable design and technological advantages allow heartmate patients to be safely discharged from the hospital...
Company:Thoratec

HeartMate in Biological News

Device helps patients survive, regain function til transplant

...ologist. The experimental device is called the heartmate II® left ventricular assist device or LVAD. It...nd funded by Thoratec Corporation, which makes the heartmate II and a larger heartmate LVAD that is already on the market, but the studys...

HeartMate in Biological Technology

Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate II(R)

PLEASANTON, Calif., April 20 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR ), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has filed a PMA (Pre-Market Approval) supplement with the FDA seeki...

Thoratec Announces HeartMate II(R) PMA Will be Reviewed by FDA Advisory Panel

PLEASANTON, Calif., Aug. 15 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR ), a world leader in products to treat cardiovascular disease, said today that its PMA (PreMarket Application) seeking approval of its HeartMate II for bridge-to-transplantation will undergo review by an ...

U.S. Federal Trade Commission to Challenge Thoratec's Proposed Acquisition of HeartWare International

...he Thoratec(R) VAD (Ventricular Assist Device) and heartmate LVAS, with more than 13,000 devices implanted in p...w.itcmed.com. Thoratec, the Thoratec logo, heartmate and heartmate II are registered trademarks of Thoratec Corporati...

Thoratec Reports 44 Percent Increase in Third Quarter Revenues

...08 Based on Continuing Adoption of heartmate II(R) PLEASANTON, Calif., Oct. 30 /PRNewswire-Fi...rmance was driven by the continued adoption of the heartmate II LVAS (Left Ventricular Assist System) for bridg...ing greater implant activity, we also added 17 new heartmate II centers during the quarter. We have now added a...

Thoratec Reports 10 Percent Increase in Fiscal 2007 Revenues; Fourth Quarter Revenues Largest in Company History

...h primarily reflects the continued adoption of the heartmate II(R) LVAS (Left Ventricular Assist System) in bot...r PMA (PreMarket Approval) allowing the use of our heartmate II for Bridge to Transplant," Burbach noted. "It... not limit our ability to increase adoption of the heartmate II. We have been engaged in a productive process w...