As promised. This is cut and paste of the substantive email. Minor deletions for privacy. You are directed more specifically to Item 3 of the reply.
29/10/08
"...can I please ask for an explanation as to why Ventracor is not openly positioning themselves against Thoratec’s recent design issues with their percutaneous lead? It would appear that this is an excellent opportunity to capitalise on superior design while protecting against lower confidence in LVADs. If not for the investors, is this not an opportunity to stimulate more interest in Ventracor’s device for the current US trials?"
*REPLY*
Thank you for your email.
1. Recalls are an unfortunate fact of life in the medical device industry. Ventracor had a recall as a result of a lead problem in 2005. 2. It is not possible to identify all causes of failure in a small clinical trial, and with about 200 patients in the PMA trial, it would have been very difficult for Thoratec to identify 1.3% at 12 months as a trend. 3. Although indications are that the VentrAssist LVAD is safe and effective, we cannot guarantee that there will not be a recall at some time in the future. Thus setting ourselves up as “superior” to the Heartmate II is a risky strategy, and we would rather focus on the stand alone strengths of our product, and let the customers draw their own conclusions. 4. All the reports from US investment analysts over the weekend would indicate that this is, at most, a “speed bump” for Thoratec, and the growth of the market will not be affected. 5. There may be more interest in the VentrAssist in the US trials arising from this situation, but we are not sure yet. Physicians are very risk averse, and one of the biggest risks in their minds is the risk of a single supplier in a monopoly position. Therefore, the clinical community will want to see two major players in the LVAD market. At the moment, that is Thoratec and Ventracor.
As we have consistently stated in the past, we want Thoratec to be very successful, as their pioneering work will pave the way for us, as the most significant competitor to Thoratec.
Thank you for your continuing support. The team at Ventracor is dedicated and working very hard to make our company successful. Please let me know if you have any further queries.
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