the product is already licenced in the usa., page-3

syringe...

You have mentioned two different devices in your post and you seem to have mixed up the story of the two devices:

HeartMate II - similar to VCR device and currently undergoing pilot trials in US (7 patient trial approved in May 2003 and 2 implants so far). But as I understand it has mechanical bearings that means additional moving parts and the added complexity to ensure mechnical reliability.

HeartMate XVE - was approved in April 2003
(In April 2003, the HeartMate XVE LVAS, an enhanced version of the HeartMate SNAP-VE, was approved for use as Destination Therapy.)

Since we are really only interested in the HeartMate II for comparison with the VCR device, can you clarify the status of the pilot testing of that device?

If you know of any other approvals for the HeartMate II device, please also clarify that for us.

Thanks