"My expectations of the DuraHeart were more than fulfilled. I got my life back!”
Ann Arbor, MI (PRWEB) April 13, 2011
Terumo Heart, Inc., a wholly owned subsidiary of Terumo Corporation, today announced that another patient implanted with the DuraHeart™ Left Ventricular Assist System (LVAS) has surpassed four years of support on the mechanical circulatory support device. Mr. Uwe Schmidt of Germany has achieved this significant milestone and joins an exclusive group of patients that have exceeded four years of support on the DuraHeart LVAS.
Mr. Schmidt received the DuraHeart LVAS as an investigational device in February 2007 at the Heart and Diabetes Center North Rhine-Westphalia. Mr. Schmidt became part of the clinical study that ultimately lead to CE Mark and commercialization of the DuraHeart LVAS in Europe. The DuraHeart LVAS is currently part of the SUSTAIN BTT clinical trial and is available as an investigational device only in the United States. “I have much confidence in the DuraHeart and don’t feel like a man with an artificial heart,” states Mr. Schmidt. “My expectations of the DuraHeart were more than fulfilled. I got my life back!”
Early in 2006, Mr. Schmidt started having symptoms of heart failure. His condition deteriorated quickly; within 3 days he could not perform simple activities without feeling dizzy and having chest pain. In February 2006 he received an ICD, but was admitted to the hospital four times in the first year. Mr. Schuster from the Düsseldorf Heart Center transferred him to Bad Oeynhausen, where Dr. Banayosy educated him on the DuraHeart. “Before receiving the DuraHeart, I was unable to do many of the things that I love. After being implanted with the DuraHeart, I’m as active as I was before becoming sick! I am now able to camp again, and I can even ride my motorbike. Nothing slows me down!”
The DuraHeart LVAS can be used as a bridge to heart transplant in patients with end stage heart failure. Due to the scarcity of donor organs, patients can sometimes be on the waiting list for many months until a suitable donor becomes available. During that time, a patient’s condition can deteriorate dramatically until no other alternative is available to them. The left ventricular assist systems offer the patient a second chance while waiting for a suitable donor.
“Mr. Schmidt is a great example of the impact the DuraHeart LVAS can have on all types of patients; from someone who has had heart failure for years, to someone who has a rapid decline in their health,” said William Pinon, President and CEO, Terumo Heart. “It is remarkable to see the impact the DuraHeart LVAS can have as a long term solution. It is gratifying that we can help patients return to lead fulfilling lives.”
The DuraHeart LVAS, the latest-generation rotary blood pump designed for long-term patient support, will be on display at the International Society for Heart and Lung Transplantation (ISHLT) annual meeting in San Diego this month. The pump features three position sensors and electromagnetic coils that suspend the impeller inside the pump chamber without any physical contact point. The impeller’s active magnetic levitation is designed to eliminate friction by allowing a wide gap between blood contacting surfaces, enabling blood to flow through the pump unimpeded in a smooth, non-turbulent fashion.
The SUSTAIN BTT trial is a multi-center, prospective, non-randomized study involving up to 140 patients across North America. The study is currently in the process of evaluating the safety and efficacy of the device in helping to sustain patients awaiting heart transplant who are at risk of death due to end-stage heart failure. The DuraHeart LVAS carries a CE Mark and is currently available for sale in European countries. The company has completed clinical trial enrollment for this device, and has recently received regulatory approval in Japan.
About Heart Failure
More than 22 million people suffer from heart failure worldwide with approximately one million new patients diagnosed annually. In the setting of an aging global population, heart failure is the number one reason for hospitalization. The most severely ill patients need heart transplants in order to recover. More than 8,000 people worldwide are on the list of eligible candidates for heart transplants annually, but less than 3,000 receive a transplant each year. A large number of people who suffer from severe heart failure do not qualify for transplantation due to other health issues. An alternative for these patients is access to artificial mechanical assist.
About Terumo Heart, Inc.
Terumo Heart, Inc. is a U.S. subsidiary of Terumo Corporation with headquarters and manufacturing facilities in Ann Arbor, Michigan. The company’s focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients. Terumo Corporation, located in Tokyo, Japan, is a leading developer, manufacturer and global marketer of a wide array of medical products. DuraHeart is limited to investigational use only in the United States, and is CE marked in Europe. For more information visit http://www.terumoheart.com