After learning of the new material on this forum, I contacted the developers in late 2002. The following are the emails I recieved:
Date: 10/22/2002
The valve is not yet available commercially. The clinical trials are planned for next year.
I have forwarded your message to Dr Ian Griffiths of AorTech Biomaterials, the company doing the development work to commercialise this valve. You can follow the progress from their web site :
www.aortechbio.com
Thank you for your interest in our work.
Regards
Thilak Gunatillake
Date: 10/25/2002
Hello
My name is Ian Griffiths and I am the business unit manager for AorTech Biomaterials. I was passed your e-mail by Thilak and as such I thought I would give you a quick update on the valve situation.
The new tri-leaflet heart valve program is ongoing and in the end stages of the pre-clinical work. The last round of testing revealed a minor issue that needs to be addressed prior to the final stage of pre-clinical work. At this stage I envisage a small delay to the timelines for clinical studies. Due to the differences in the device registration process in different parts of the world the full commercial launch will be staged between 2005 and 2007.
All relevant data at this time indicates that no anticoagulation regime will be required for this valve. However we will not be absolutely certain of this until we have sufficient human data. The current design will address replacement in the aortic position, but may be broadened for other valve replacement in the future.
I hope that this answers your points and thank you for the interest.
Best Regards
Ian
Dr Ian Griffiths
Business Unit Manager
AorTech Biomaterials
Dr. Griffiths also indicated the valve is effectively silent in operation.
