Thoratec Announces First European HeartMate(R) II Implant in Germany

Apr 05, 2001, 01:00 ET from Thoratec Corporation

    PLEASANTON, Calif., April 5 /PRNewswire/ -- Thoratec Corporation
 (Nasdaq: THOR), a medical device company, said today that a 61-year-old German
 man suffering from ischemic cardiomyopathy has become the first patient in
 Europe implanted with the HeartMate II, a second generation left
 ventricular-assist system (LVAS).
     The company will be seeking approval to market and sell the device as a
 long-term cardiac support system for critically ill heart failure patients,
 including those not eligible for a heart transplant. The first implant of a
 HeartMate II occurred last year in Israel.
     The procedure, which took just two-and-half hours, was performed at the
 Heart Center of North Rhine-Westphalia, Bad Oeynhausen, in Germany on
 March 28, 2001. The clinical team included Professor Reiner Korfer and
 Drs. Aly El-Banayosy and Latif Arusolglu.
     "This is an important and exciting milestone in our international clinical
 trial program for the device and our plans to file an Investigational Device
 Exemption to begin clinical trials in the U.S.," noted D. Keith Grossman,
 president and chief executive officer of Thoratec. "The HeartMate II is a key
 element of our strategy to offer a full spectrum of cardiac assist products,
 and to dramatically expand our markets over time with smaller, improved
 technologies, as well as expanded patient applications. Thus far, we are
 delighted with this patient's experience with the device, as well as the
 enthusiastic response of the clinical team. We intend to use our newly
 expanded resources to accelerate the evaluation of the HeartMate II as quickly
 as possible in Europe, as well as in the U.S.," he added.
     The HeartMate II is an implantable LVAS consisting of a miniature rotary
 blood pump that is designed to provide long-term support. The device weighs
 approximately 12 ounces and is approximately 1.5 inches in diameter and
 2.5 inches long. Because of its small size, the device can accommodate a broad
 range of patients, including small adults and children. Its design is intended
 to be not only smaller, but also simpler, quieter, and longer-lasting than
 current generation assist devices.
     The HeartMate II is based on some of the technology and features of the
 highly successful HeartMate LVAS device that has been implanted in more than
 2,400 patients, ranging in age from 11 to 72 years old. The device is
 implanted alongside the natural heart and takes over the pumping function of
 the left ventricle for patients whose hearts are too damaged or diseased to
 produce adequate blood flow. Both a pneumatic (air-driven) and an electric
 system are approved by the FDA and are widely used in the U.S., Europe and
 Asia. In the U.S., the device is used as a bridge to transplant, while in
 Europe it is used both as a bridge to transplant and for long-term cardiac
 support, or "destination therapy."
     Formerly known as Thoratec Laboratories, the company is engaged in the
 research, development, manufacturing and marketing of medical devices for
 circulatory support and vascular graft applications. The Thoratec(R)
 Ventricular Assist Device (VAD) System is the only ventricular assist device
 that is approved for use both as a bridge-to-transplant and for recovery from
 open-heart surgery and has been used in the treatment of more than
 1,500 patients. The company is also a leader in the research, development and
 manufacture of LVAS devices.
     The company's other products include the Vectra(TM) vascular access graft,
 which is used in patients undergoing hemodialysis, and is approved for sale in
 the U.S., Europe and Japan and a number of other foreign countries. Its
 Aria(TM) coronary artery bypass graft, which is designed for use by patients
 having too few suitable native blood vessels, is currently in clinical trials
 in the U.S. The company's International Technidyne division supplies
 whole-blood coagulation testing equipment and related disposable, as well as
 single-use skin-incision devices. Headquartered in Pleasanton, California, the
 company also has facilities in Woburn and Chelmsford, Massachusetts,
 Rancho Cordova, California, and Edison, New Jersey. For more information,
 visit the company's web sites at http://www.thoratec.com or
 http://www.itcmed.com .
     The portions of this news release that relate to future plans, events or
 performance are forward-looking statements. Investors are cautioned that all
 such statements involve risks and uncertainties, including risks related to
 the merger and benefits thereof, government regulatory approval processes and
 market acceptance of new products. These factors, and others, are discussed
 more fully under the heading of "Risk Factors" in Thoratec's 10-K for the
 fiscal year ended December 30, 2000, and other filings with the Securities and
 Exchange Commission. Actual results, events or performance may differ
 materially. These forward-looking statements speak only as of the date hereof.
 Thoratec undertakes to 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
    PLEASANTON, Calif., April 5 /PRNewswire/ -- Thoratec Corporation
 (Nasdaq: THOR), a medical device company, said today that a 61-year-old German
 man suffering from ischemic cardiomyopathy has become the first patient in
 Europe implanted with the HeartMate II, a second generation left
 ventricular-assist system (LVAS).
     The company will be seeking approval to market and sell the device as a
 long-term cardiac support system for critically ill heart failure patients,
 including those not eligible for a heart transplant. The first implant of a
 HeartMate II occurred last year in Israel.
     The procedure, which took just two-and-half hours, was performed at the
 Heart Center of North Rhine-Westphalia, Bad Oeynhausen, in Germany on
 March 28, 2001. The clinical team included Professor Reiner Korfer and
 Drs. Aly El-Banayosy and Latif Arusolglu.
     "This is an important and exciting milestone in our international clinical
 trial program for the device and our plans to file an Investigational Device
 Exemption to begin clinical trials in the U.S.," noted D. Keith Grossman,
 president and chief executive officer of Thoratec. "The HeartMate II is a key
 element of our strategy to offer a full spectrum of cardiac assist products,
 and to dramatically expand our markets over time with smaller, improved
 technologies, as well as expanded patient applications. Thus far, we are
 delighted with this patient's experience with the device, as well as the
 enthusiastic response of the clinical team. We intend to use our newly
 expanded resources to accelerate the evaluation of the HeartMate II as quickly
 as possible in Europe, as well as in the U.S.," he added.
     The HeartMate II is an implantable LVAS consisting of a miniature rotary
 blood pump that is designed to provide long-term support. The device weighs
 approximately 12 ounces and is approximately 1.5 inches in diameter and
 2.5 inches long. Because of its small size, the device can accommodate a broad
 range of patients, including small adults and children. Its design is intended
 to be not only smaller, but also simpler, quieter, and longer-lasting than
 current generation assist devices.
     The HeartMate II is based on some of the technology and features of the
 highly successful HeartMate LVAS device that has been implanted in more than
 2,400 patients, ranging in age from 11 to 72 years old. The device is
 implanted alongside the natural heart and takes over the pumping function of
 the left ventricle for patients whose hearts are too damaged or diseased to
 produce adequate blood flow. Both a pneumatic (air-driven) and an electric
 system are approved by the FDA and are widely used in the U.S., Europe and
 Asia. In the U.S., the device is used as a bridge to transplant, while in
 Europe it is used both as a bridge to transplant and for long-term cardiac
 support, or "destination therapy."
     Formerly known as Thoratec Laboratories, the company is engaged in the
 research, development, manufacturing and marketing of medical devices for
 circulatory support and vascular graft applications. The Thoratec(R)
 Ventricular Assist Device (VAD) System is the only ventricular assist device
 that is approved for use both as a bridge-to-transplant and for recovery from
 open-heart surgery and has been used in the treatment of more than
 1,500 patients. The company is also a leader in the research, development and
 manufacture of LVAS devices.
     The company's other products include the Vectra(TM) vascular access graft,
 which is used in patients undergoing hemodialysis, and is approved for sale in
 the U.S., Europe and Japan and a number of other foreign countries. Its
 Aria(TM) coronary artery bypass graft, which is designed for use by patients
 having too few suitable native blood vessels, is currently in clinical trials
 in the U.S. The company's International Technidyne division supplies
 whole-blood coagulation testing equipment and related disposable, as well as
 single-use skin-incision devices. Headquartered in Pleasanton, California, the
 company also has facilities in Woburn and Chelmsford, Massachusetts,
 Rancho Cordova, California, and Edison, New Jersey. For more information,
 visit the company's web sites at http://www.thoratec.com or
 http://www.itcmed.com .
     The portions of this news release that relate to future plans, events or
 performance are forward-looking statements. Investors are cautioned that all
 such statements involve risks and uncertainties, including risks related to
 the merger and benefits thereof, government regulatory approval processes and
 market acceptance of new products. These factors, and others, are discussed
 more fully under the heading of "Risk Factors" in Thoratec's 10-K for the
 fiscal year ended December 30, 2000, and other filings with the Securities and
 Exchange Commission. Actual results, events or performance may differ
 materially. These forward-looking statements speak only as of the date hereof.
 Thoratec undertakes to 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