October 4, 1994. Copyright, 1994, Graphic News. All rights reserved ANOTHER CHANCE FOR HEART TRANSPLANT PATIENTS By Julie Hacking LONDON October 4, Graphic News- An innovative medical device which keeps patients alive while waiting for a donor heart has become the first implantable cardiac-assist system to win approval from the influential U.S. Food and Drug Administration, and is now set to become widely used in Europe. The HeartMate was developed by Thermo Cardiosystems Inc. of Massachusetts to provide long term support for patients awaiting heart transplants. The company believes it is the most effective available treatment because it dramatically reduces major side-effects, particularly blood clots - associated with similar devices or artificial hearts. The essential difference between this device and that implanted into a patient at Papworth Hospital in August is the HeartMate system's unique textured blood-contacting surfaces. Clinical trials of the HeartMate show these surfaces provide an impressively low risk of blood clots, which can lead to strokes. The nine-year clinical study also proved that the HeartMate doubled the rate of survival for patients waiting for a donor heart and revealed that the success rate of natural heart transplants was over 20 per cent higher than in patients who had not used the device. This is because it allows other organs which have suffered during heart failure to begin recovery, enabling patients to be in better condition before undergoing a heart transplant. The air-driven LVAS (left ventricular-assist system) supports the patient's natural heart when the main pumping chamber, the left ventricle, is no longer strong enough to pump oxygen-rich blood from the lungs. The HeartMate allows a patient's heart to be left in place so it can still perform its natural biological functions and is surgically connected between the heart and the aorta, the main artery leaving the heart. Blood is then directed from the heart into the HeartMate, which produces the force necessary to pump blood throughout the body. The system weighs about one and a half pounds, is approximately four inches in diameter and less than two inches thick. Development of the HeartMate LVAS began in 1966 and has cost more than $50 million in research funding. During clinical trials it has been used in patients ranging from ages 14 to 66 - the average duration of support being 76 days, with several patients being supported on the device for approximately one year. The HeartMate has now been implanted in more than 250 patients in the U.S. and Europe. Sources: Thermo Cardiosystems Inc., Brunswick For more information, clinical trial data and video news releases, please call; James Garthwaite, Kevin Byram or Lesley Springall at Brunswick, London, on 071 404 5959 ( if outside UK dial (44) 71 404 5959) or Joanne Kern at Thermo Electron, Massachusetts on (1) 617 622 1252 October 4, 1994. Copyright, 1994, Graphic News. All rights reserved ANOTHER CHANCE FOR HEART TRANSPLANT PATIENTS By Julie Hacking LONDON October 4, Graphic News- An innovative medical device which keeps patients alive while waiting for a donor heart has become the first implantable cardiac-assist system to win approval from the influential U.S. Food and Drug Administration, and is now set to become widely used in Europe. The HeartMate was developed by Thermo Cardiosystems Inc. of Massachusetts to provide long term support for patients awaiting heart transplants. The company believes it is the most effective available treatment because it dramatically reduces major side-effects, particularly blood clots - associated with similar devices or artificial hearts. The essential difference between this device and that implanted into a patient at Papworth Hospital in August is the HeartMate system's unique textured blood-contacting surfaces. Clinical trials of the HeartMate show these surfaces provide an impressively low risk of blood clots, which can lead to strokes. The nine-year clinical study also proved that the HeartMate doubled the rate of survival for patients waiting for a donor heart and revealed that the success rate of natural heart transplants was over 20 per cent higher than in patients who had not used the device. This is because it allows other organs which have suffered during heart failure to begin recovery, enabling patients to be in better condition before undergoing a heart transplant. The air-driven LVAS (left ventricular-assist system) supports the patient's natural heart when the main pumping chamber, the left ventricle, is no longer strong enough to pump oxygen-rich blood from the lungs. The HeartMate allows a patient's heart to be left in place so it can still perform its natural biological functions and is surgically connected between the heart and the aorta, the main artery leaving the heart. Blood is then directed from the heart into the HeartMate, which produces the force necessary to pump blood throughout the body. The system weighs about one and a half pounds, is approximately four inches in diameter and less than two inches thick. Development of the HeartMate LVAS began in 1966 and has cost more than $50 million in research funding. During clinical trials it has been used in patients ranging from ages 14 to 66 - the average duration of support being 76 days, with several patients being supported on the device for approximately one year. The HeartMate has now been implanted in more than 250 patients in the U.S. and Europe. Sources: Thermo Cardiosystems Inc., Brunswick For more information, clinical trial data and video news releases, please call; James Garthwaite, Kevin Byram or Lesley Springall at Brunswick, London, on 071 404 5959 ( if outside UK dial (44) 71 404 5959) or Joanne Kern at Thermo Electron, Massachusetts on (1) 617 622 1252 October 4, 1994. Copyright, 1994, Graphic News. All rights reserved ANOTHER CHANCE FOR HEART TRANSPLANT PATIENTS By Julie Hacking LONDON October 4, Graphic News- An innovative medical device which keeps patients alive while waiting for a donor heart has become the first implantable cardiac-assist system to win approval from the influential U.S. Food and Drug Administration, and is now set to become widely used in Europe. The HeartMate was developed by Thermo Cardiosystems Inc. of Massachusetts to provide long term support for patients awaiting heart transplants. The company believes it is the most effective available treatment because it dramatically reduces major side-effects, particularly blood clots - associated with similar devices or artificial hearts. The essential difference between this device and that implanted into a patient at Papworth Hospital in August is the HeartMate system's unique textured blood-contacting surfaces. Clinical trials of the HeartMate show these surfaces provide an impressively low risk of blood clots, which can lead to strokes. The nine-year clinical study also proved that the HeartMate doubled the rate of survival for patients waiting for a donor heart and revealed that the success rate of natural heart transplants was over 20 per cent higher than in patients who had not used the device. This is because it allows other organs which have suffered during heart failure to begin recovery, enabling patients to be in better condition before undergoing a heart transplant. The air-driven LVAS (left ventricular-assist system) supports the patient's natural heart when the main pumping chamber, the left ventricle, is no longer strong enough to pump oxygen-rich blood from the lungs. The HeartMate allows a patient's heart to be left in place so it can still perform its natural biological functions and is surgically connected between the heart and the aorta, the main artery leaving the heart. Blood is then directed from the heart into the HeartMate, which produces the force necessary to pump blood throughout the body. The system weighs about one and a half pounds, is approximately four inches in diameter and less than two inches thick. Development of the HeartMate LVAS began in 1966 and has cost more than $50 million in research funding. During clinical trials it has been used in patients ranging from ages 14 to 66 - the average duration of support being 76 days, with several patients being supported on the device for approximately one year. The HeartMate has now been implanted in more than 250 patients in the U.S. and Europe. Sources: Thermo Cardiosystems Inc., Brunswick For more information, clinical trial data and video news releases, please call; James Garthwaite, Kevin Byram or Lesley Springall at Brunswick, London, on 071 404 5959 ( if outside UK dial (44) 71 404 5959) or Joanne Kern at Thermo Electron, Massachusetts on (1) 617 622 1252