1. What is the Arrow LionHeartTM left ventricular assist system?
    The Arrow LionHeart™ LVAS is designed as destination therapy for patients and represents a significant advance in mechanical circulatory assist technology. The device has no lines or cables protruding through the skin to power the system, thus eliminating a potential source of patient infection. It is fully implanted in the body and does not replace the heart, but assists in the pumping function of the heart's left ventricle. The device operates with an energy transmission system that does not require puncturing the skin.
  2. What is meant by "destination therapy?"
    Destination therapy" indicates that a device is intended to be the primary therapy that is applied over an extended period of time. It is not planned to be replaced by an alternate therapy. In this case, the Arrow LionHeart™ LVAS is an implanted destination therapy system that is intended to assist severe congestive heart failure patients who are unresponsive to medical therapy and who are considered ineligible to receive a heart transplant. Importantly, the Arrow LionHeart™ LVAS is not a temporarily-implanted device for patients awaiting a heart transplant.
  3. What is unique about the Arrow LionHeartTM LVAS as compared to other LVAS devices?
    The Arrow LionHeart™ LVAS is the first fully-implantable left ventricular assist system with no lines or cables coming through the skin to power the device in clinical use. It is also the first fully implantable "alternative" for patients ineligible for heart transplantation. The unique features of the Arrow LionHeart™ LVAS are expected to significantly reduce the incidence of infections, an adverse event that frequently results with currently available implantable systems with drive and vent lines. The Arrow LionHeart™ LVAS uses a transcutaneous energy transfer system to charge internal batteries and power the blood pump. Internal batteries allow the patient to "de-couple" from all external components of the system, allowing "tether free" mobility for a specified amount of time. The Arrow LionHeart™ LVAS utilizes a compliance chamber to accommodate gas volume fluctuations with each "beat" of the pump, thus eliminating the need for a percutaneous, through-the-skin, vent tube. The Arrow LionHeart™ LVAS is the first device to combine implantable features successfully in a mechanical assist system in humans. These features are expected to significantly reduce the incidence of adverse events and improve the quality of life for the patient.
  4. How is the Arrow LionHeartTM system different from other heart-assist devices?
    The main distinction between the Arrow LionHeart™ LVAS and other heart-assist devices is that the Arrow LionHeart™ operates with no lines or cables protruding through the patient's skin. This feature eliminates a source of potentially life-threatening infections, which may be experienced by patients who receive other heart-assist devices.
    By operating with no lines or cables protruding through the patient's skin, Arrow LionHeart™ recipients can de-couple their external power sources for periods of time allowing them to engage in normal activities, such as taking showers and baths, without requiring special preparations for the device.
    The Arrow LionHeart™ LVAS provides a pulsatile supplement to the patient's natural cardiac activity, as compared to several other heart-assist devices, which only provide relatively pulseless support.
    The modular design of the Arrow LionHeart™ LVAS allows for the customized placement and exchange of implanted sub-systems in each patient.
    A fully automatic control algorithm in the Arrow LionHeart™ responds automatically to a patient's changing demands for circulatory support, as opposed to other heart-assist systems that are just entering the clinical arena, which require manual adjustment of the pump speed.
  5. How is the Arrow LionHeartTM LVAS different from a total artificial heart?
    The Arrow LionHeart™ is fully implanted in the body and does not replace the heart, but assists in the pumping function of the heart's left ventricle. Conversely, the heart is removed from the patient's body when replaced by a total artificial heart. Both systems provide cardiac support to the recipient. However, the Arrow LionHeart™ LVAS supplements the native heart's function by optimizing the amount of cardiac output that can be produced for an individual patient whereas a total artificial heart pumps all of the blood for a patient.
  6. What will happen if the LVAS pump stops?
    Because the patient retains his or her natural heart, it is anticipated that the residual function of the heart will be adequate to sustain circulation until the patient can be transferred to the implant center for assistance.
  7. Why was the first implant surgery performed in Germany rather than in the United States?
    Arrow has been pursuing regulatory approvals simultaneously in the United States and in Europe. The process in Europe took less time. Bad Oeynhausen, Germany was chosen as the first site to do the implant based on its extensive experience with numerous mechanical assist devices, and the expertise of not only the surgical team, but also a well established post-implant support program, which enables patients to be discharged from the hospital.
  8. When will the Arrow LionHeartTM LVAS be available in the United States?
    The Arrow LionHeart™LVAS became clinically available in the U.S on an investigational use basis when the FDA approved the Phase I clinical trial in 2001.
  9. What is the history of the Arrow LionHeartTM development and how many patients to date have received the Arrow LionHeartTM LVAS?
    Arrow began a collaborative effort with the Department of Surgery's Division of Artificial Organs at Penn State College of Medicine in 1993. Predecessors to the Arrow LionHeart™LVAS were designed, built and tested at Penn State Hershey Medical Center over the course of the last 30 years. The earliest designs were pneumatic and have been used clinically in over 1,000 patients as a short-term "bridge-to-transplant" VAD, and the current version of this pneumatic device is still used clinically today. In the early 1980s, work began on an electrical version of the pump. By 1993, the research team at Penn State College of Medicine developed a sophisticated, totally implantable left ventricular assist system capable of providing supplemental flow to a failing heart. Arrow then applied its medical device manufacturing expertise to further develop, in collaboration with Penn State Hershey Medical Center, the Arrow LionHeart™ LVAS to its present state. See our Timeline for more information.
  10. Who is sponsoring the clinical trials in Europe and the United States?
    Arrow International, Inc., headquartered in Reading, Pennsylvania.