EVAHEART MEDICAL USA

    EVAHEART MEDICAL USA, INC
       
           

Frequently Asked Questions

 
Home Company Info System Info Publications News Events Contact Us FAQ Sun Medical  

Printable Version

 

General Questions

Clinical Inquiries

  1. What is the EVAHEART? How does it work?
  2. Is it noisy?
  3. What does it look like? Do I have to carry anything?
  4. What is the maintenance of the system?
  5. How long can the EVAHEART operate? How long will I be on the EVAHEART?
  6. Will I still be able to participate in physical activities?
  7. Can I go home with the EVAHEART?
  8. What is the availability of the EVAHEART? Where do I go to get an EVAHEART implanted?
  9. How much will this cost?
  10. Who should I contact if I have additional questions?

1. What is the EVAHEART? How does it work?
The EVAHEART is a type of artificial heart, called a left ventricular assist system (LVAS), which is designed to help the heart pump blood throughout the body. A tube is inserted into the left ventricle (the main pumping chamber of the heart), which allows blood to be emptied into the pump. The EVAHEART is a centrifugal pump and has a spinning impeller inside that propels the blood through another tube to the aorta and the rest of the body.

top of page

2. Is it noisy?
By design, centrifugal pumps are quiet, and do not produce any noticeable noise.

top of page

3. What does it look like? Do I have to carry anything?
The EVAHEART LVAS is about the size of a tennis ball (approximately 58mm diameter x 76mm high), and is made out of titanium. The external components consist of a Controller (240 x 308 x 82mm) and 2 batteries (each 171 x 78 x 44mm), which are carried in a specially designed case. The total weight of the carried items is approximately 5.7 kg (12.5 lbs.)

EVAHEART pump       EVAHEART Controller
EVAHEART pump                               EVAHEART Controller

top of page

4. What is the maintenance of the system?
Daily management consists of checking batteries, recording device parameters, and doing a dressing change on the driveline exit site.

top of page

5. How long can the EVAHEART operate? How long will I be on the EVAHEART?
The EVAHEART has been designed for long term (multi-year) application. Your time on the EVAHEART will depend on your specific medical condition and your status on the hospital transplant waiting list.

top of page

6. Will I still be able to participate in physical activities?
Yes, once you have recovered from the implant surgery, you will be able to resume most physical activities. For your safety and for the proper function of your EVAHEART, avoid the following activities:

  • running or jogging, or exercises that involve running
  • participation in contact exercises or sports that have a high risk of falling or injury
  • swimming or other water sports.
If in doubt, please check with your physician.

top of page

7. Can I go home with the EVAHEART?
The compact size of the EVAHEART Controller allows patients to be discharged home to await transplantation.

top of page

8. What is the availability of the EVAHEART? Where do I go to get an EVAHEART implanted?
Currently, the EVAHEART is not available for use in the United States. Clinical trials began in Japan during May, 2005. The clinical trial in the US is planned for late 2008, and will be as a bridge to transplantation. For both trials, the EVAHEART will only be available through enrollment at certain hospitals. Contact EMUSA for further details.

top of page

9. How much will this cost?
As an investigational device, prices are reduced to cover manufacturing costs. Payment will be arranged through your insurance provider.

top of page

10. Who should I contact if I have additional questions?
Please direct any additional general questions to EMUSA.
For clinical queries, contact EMUSA-Clinical for further details.

top of page

 

 

 

 

The use of pictures, descriptions, or any other information from this website may not be used in any printed, visual or audible publication without the expressed written consent of EVAHEART MEDICAL USA, Inc. or SUN MEDICAL TECHNOLOGY RESEARCH CORPORATION.

  Date lasted modified: January 21, 2008   |  Webmaster