Navigation Links
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 company's PMA (PreMarket Approval) allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) as a bridge-to-transplantation (BTT).

The HeartMate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure.

"We are delighted with the panel's recommendation indicating their belief that the data demonstrate the safety and efficacy of the device. This represents a major step in our program to make this state-of-the-art circulatory support technology commercially available in the U.S. for patients suffering from advanced-stage heart failure," said Gary F. Burbach, president and chief executive officer of Thoratec. "We believe the data reflect the positive experience of patients in the trial and that the HeartMate II represents a significant breakthrough in the treatment of heart failure and look forward to continuing what has been to date a positive dialogue with the FDA around this submission and achieving approval," he added.

The leading clinical presenters were Dr. Leslie Miller, Walters Chair of Cardiovascular Medicine and Director of Cardiology Programs at Washington Hospital Center & Georgetown University Hospital, and Dr. Francis Pagani, Director, Heart Transplant Program, University of Michigan Hospital.

The conditions outlined in the panel's recommendations related to clarifications on labeling for the device regarding small patients and those unable to be treated with anti-coagulation therapy, and elements of the post-approval study.

An implantable LVAS powered by a rotary pumping mechanism, the HeartMate II is significantly smaller than currently approved devices, enabling an easier implantation in a broader population of patients. The HeartMate II is designed to have a much longer functional life than other approved devices and to operate more simply and quietly. The device provides blood flow through the circulatory system on a continuous basis with only one moving part.

Thoratec Corporation is a world leader in hemodynamic restoration therapy-developing products to treat cardiovascular disease. The company's product line includes the Thoratec(R) VAD (Ventricular Assist Device) and HeartMate II LVAS with more than 11,000 devices implanted in patients suffering from heart failure. Additionally, its International Technidyne Corporation (ITC) division supplies blood testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's web sites at or

Many of the preceding paragraphs, particularly but not excluding those addressing future performance, contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words "expects," "believes," "could," "will," and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond Thoratec's control. Therefore, readers are cautioned not to put undue reliance on these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to the results of enrollment in and timing of clinical trials, including the HeartMate II, regulatory approval processes, the development of new markets, including Destination Therapy, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, and the effects of healthcare reimbursement and coverage policies. Forward-looking statements contained in this press release should be considered in light of these factors and those factors discussed from time to time in Thoratec's public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, "Risk Factors," in Thoratec's most recent annual report on Form 10-K, and as may be updated in subsequent SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

SOURCE Thoratec Corporation
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Thoratec Schedules Third Quarter Conference Call, Webcast
2. Thoratecs ITC Division Receives FDA Warning Letter
3. URGENT Thoratec Corporation Worldwide Recall of Implantable Ventricular Assist Device
4. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
5. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
6. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
7. HEI, Inc. Announces Sale of RFID Division Assets
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
9. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
10. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
11. Brooke Franchise Corporation Announces Selected July Results
Post Your Comments:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal ... Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. ... Cut Pro X users can now reveal the media of their split screens ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... strategic partnership with Connance, a healthcare industry leader providing predictive analytics to ... technology combine to provide health systems, hospitals and ambulatory surgical centers with ...
(Date:6/27/2016)... Park, KS (PRWEB) , ... June 27, 2016 , ... ... in retailers of Eyeglasses . , Millions of individuals in the United States ... eyeglasses have become a way to both correct vision and make a fashion statement. ...
(Date:6/26/2016)... Michigan (PRWEB) , ... June 26, 2016 , ... On ... as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle ... honor of the city’s history as home to some of the world’s leading providers ...
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Consumers have taken ... regulators/payers have placed more emphasis on patient outcomes. ... support programs in the pharmaceutical industry have evolved ... Consequently, pharmaceutical companies are focusing on becoming more ... providing products and services that improve health. ...
(Date:6/24/2016)... , June 24, 2016 ... Markets has announced the addition of the " ... offering. This ... and provides an updated review, including its applications in ... the total market, which includes three main industries: pharmaceutical ...
(Date:6/24/2016)... , June 24, 2016  American Respiratory Labs (ARL), a ... now able to perform sophisticated lung assessments in patients, homes, thanks ... Inc. Patients are no longer limited to having ... PRO ® , ARL patients like Jeanne R. of ... the comfort of her own home. ...
Breaking Medicine Technology: