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Heart Failure Patient Supported By DuraHeart™ Left-Ventricular Assist System Receives Successful Donor Transplant After Four Years On Device
Date:12/22/2009

Terumo Heart, Inc., a wholly owned subsidiary of Terumo Corporation, today announced that one of its earliest patients to receive the DuraHeart™ Left Ventricular Assist System (LVAS) has received a donor heart transplant, nearly four years after receiving the mechanical circulatory support device. Rudolf Schmidthorst, 63, Germany, became one of the longest-living recipients of this device designed to aid the pumping action of the heart in order to circulate blood throughout his body.

(PRWEB) December 22, 2009 -- Terumo Heart, Inc., a wholly owned subsidiary of Terumo Corporation, today announced that one of its earliest patients to receive the DuraHeart™ Left Ventricular Assist System (LVAS) has received a donor heart transplant, nearly four years after receiving the mechanical circulatory support device. Rudolf Schmidthorst, 63, Germany, became one of the longest-living recipients of this device designed to aid the pumping action of the heart in order to circulate blood throughout his body.

Schmidthorst received the then investigational device in November 2005, taking part in the DuraHeart™ LVAS clinical trial. He was treated by Latif Arusoglu, MD and Michiel Morshuis, MD, and their team at the Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes center NRW, University Hospital of the Ruhr-University of Bochum in Bad Oeynhausen, Germany, as part of a clinical study that would ultimately lead to the device’s CE Mark and commercialization in Europe of the DuraHeart LVAS.

“I am so very lucky to have received a new heart, and another new opportunity to live my life,” said Rudolf Schmidthorst. “The DuraHeart made it possible for me to reach this day.”

A heart attack detected too late caused irreparable damage to the patient's myocardium (layer of the heart wall). Physicians at the Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes center NRW, University Hospital of the Ruhr-University of Botchum, Bad Oeynhausen, Germany, determined Schmidthorsts need for a heart transplant, but were fairly certain he would not survive while waiting for a donor heart without the help of an LVAS.

A heart attack detected too late caused irreparable damage to the patient's myocardium (layer of the heart wall). Physicians at the Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes center NRW, University Hospital of the Ruhr-University of Botchum, Bad Oeynhausen, Germany, determined Schmidthorsts need for a heart transplant, but were fairly certain he would not survive while waiting for a donor heart without the help of an LVAS.

“Patients suffering from late-stage heart failure, and in need of a transplant, are often at the mercy of an unpredictable timeline for a compatible donor heart,” said Professor Jan Gummert, M.D., Cardiothoracic Surgeon and Director of the Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes center NRW, University Hospital of the Ruhr-University of Bochum in Bad Oeynhausen, Germany. “Device performance and durability are critical for these patients, and the DuraHeart has consistently shown its ability to deliver long-term benefits. We have tremendous confidence in the device.”

The intent of the implant of the DuraHeart LVAS was as a bridge to transplant. 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

“I have been able to live a normal life with the DuraHeart,” said Schmidthorst. “Over the past four years, the external components of the DuraHeart became a natural extension of my body, allowing me to do most everything and go anywhere. I truly appreciate the second chance that this life-sustaining technology provided to me until a suitable donor heart became available.”

“We are grateful for the contribution we are making to the treatment of heart failure patients,” said William Pinon, President and CEO, Terumo Heart. “This is a significant milestone that further documents the importance and value of LVAS technology for its potential to improve the length and quality of patients’ lives.”

The DuraHeart LVAS is the first, third-generation rotary pump designed for long-term patient support that incorporates a centrifugal flow rotary pump with an active magnetically levitated impeller featuring three position sensors and magnetic coils that optimize blood flow, while minimizing device wear and tear. The DuraHeart LVAS is currently being studied in the U.S. in the DuraHeart Pivotal Trial for Bridge-to-Transplant, a multi-center, prospective, non-randomized study, involving 140 patients. The study will evaluate 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 left ventricular failure. The DuraHeart LVAS carries a CE Mark and is currently available for sale in European countries. Additionally, the company has completed clinical trial enrollment for this device 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 will 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 devices. Left Ventricular Assist Systems are a type of mechanical circulatory device specifically designed to improve the quality of life of the patients waiting for donor hearts, as well as those who are ineligible for a heart transplant.

About Hospital
In the Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany, all manner of cardiosurgical operating techniques are performed, including surgery on congenital and complex heart defects, with over 4300 open-heart interventions with heart-lung machine per annum and over 1500 interventions without heart-lung machine. As well as the intensive care and transplantation unit, the Clinic has at its disposal four additional wards and a VAD ward for patients with mechanical assist devices. With over 1600 heart and heart-lung transplantations and over 1500 artificial heart operations being performed, the clinic in Bad Oeynhausen is at the very forefront of its international field.

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 www.terumoheart.com.

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