Ann Arbor-based Terumo Heart Inc., a subsdiary of Japan’s Terumo Corp., Wednesday announced that another patient implanted with the DuraHeart Left Ventricular Assist System has surpassed four years after receiving the mechanical circulatory support device.
Helga Gieseke, 66, who lives in the south of Saxony-Anhalt, Germany, is now one of the longest-living heart failure recipients of this device designed to aid the pumping action of the heart in order to circulate blood throughout her body.
Gieseke received the DuraHeart LVAS as an investigational device in May 2006 after suffering from heart failure for many years. She was treated by the Physicians at The Deutsches Herzzentrum Berlin (DHZB, German Heart Institute Berlin) as part of the DuraHeart LVAS clinical study that ultimately lead to CE Mark and commercialization in Europe.
“I feel fortunate to have had the opportunity to continue doing many of the things I enjoy,” Gieseke said. “I am thankful to all of the people involved in my care; it gives me the opportunity to spend more time with my family and see my grandchildren grow up. I’ve grown accustomed to having the device with me as it truly has become an important part of who I am; a patient living with chronic heart disease.”
Gieseke has had a long history of heart problems; her first heart surgery was performed in 1994. Since then, Gieseke had undergone several procedures including implantation of stents, pacemakers and implantable defibrillators in an attempt to manage her condition.
Despite all these treatments, Gieseke’s condition continued to deteriorate until she found herself unable to walk or carry out simple activities around the house without getting chest pain. It was after admission to the local hospital in April of 2006 that Gieseke was told by her cardiologist, also a school friend, that she required additional treatment. It was then that she was referred to DHZB.
“When Mrs. Gieseke was admitted in our institution, she was in an advanced stage of chronic heart failure,” said DHZB director Roland Hetzer. “Only an immediate heart transplant would have solved the problem, but a suitable donor heart was not available. Instead, we explained that she would need a mechanical heart assist device and proposed that she participate in the DuraHeart LVAS clinical trial. She has done extremely well living with the DuraHeart LVAS, which has proven to be quite durable and capable of providing the critical long-term support required by our heart failure patients.”
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
“Mrs. Gieseke is yet another excellent example of the important work that leading Physicians around the world can accomplish in treating end stage heart failure, supported by the people at Terumo Heart,” said Terumo Heart president and CEO William Pinon. “It is truly gratifying to see the impact of our DuraHeart LVAS in bringing long-term quality of life back to patients who otherwise would have few options for treatment in the absence of a heart transplant.”
The DuraHeart LVAS is the latest-generation rotary blood pump designed for long-term patient support. The system incorporates a centrifugal flow rotary pump with the magnetically levitated impeller. The pump features three position sensors and electromagnetic coils that suspend the impeller inside the pump chamber without a single 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 DuraHeart LVAS is currently being studied in the DuraHeart Pivotal U.S. Trial for Bridge-to-Transplant, a multi-center, prospective, non-randomized study, involving 140 patients. The study, which was granted unconditional approval in early 2010 by the U.S. Food & Drug Administration, 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 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 in Japan. Additionally, Terumo Heart has submitted its Destination Therapy Investigational Device Exemption to the FDA, which is a first step in the process of obtaining approval to begin its DuraHeart DT Clinical Trial in the U. S.
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