Sydney, Feb 18, 2009 AEST (ABN Newswire) - Ventracor Limited (ASX:VCR)(PINK:VTCRY) is responding to an article that appeared in "The Australian" newspaper on February 18, which in the Company's view makes incorrect and misleading allegations regarding the Company and its product the VentrAssist(R) Left Ventricular Assist Device (LVAD).
As stated in the Company's announcement of 10 February 2009, the Company has issued an Urgent Field Safety Notice regarding the Model LVA4 VentrAssist LVAD, catalogue number VA166. This voluntary and precautionary action advised physicians not to implant the VA166 until further analysis had been undertaken.
The Company took this action as the Company always has, and always will, put the safety of patients first. The Company denies the allegation made in the article that 11 cases of conductor fracture involved 'product faults'. Conductor fracture has been caused in three cases by accidental trauma (such as cutting implements).
In all the other eight cases, it has now been confirmed that the patients did not wear a lead support belt in accordance with instructions for use. The lead support belt is provided to support and protect the lead. The Company has received no reports of conductor fracture in cases where it is established that patients have fully complied with instructions, including the use of the lead support belt.
The Company is continuing its investigation in close consultation with the Australian Therapeutic Goods Administration. The Company confirms that it is in full compliance with its obligation to make continuous disclosure pursuant to ASX Listing Rule 3.1. The Company takes its obligations under ASX requirements very seriously and requested a trading halt immediately upon the decision to issue the Field Safety Notice.
The Company maintains that it did not have any such obligation to disclose the three deaths mentioned in its announcement on 10 February 2009 at the time of those individual deaths. After informing medical device regulatory authorities, there was no requirement to suspend implants or its clinical trials and, consequently, the Company considers that there was no material announcement to be made at the time.
Patients may ultimately die from diverse causes, including their general medical condition. Although the Company recognises that such events are distressing for those involved, it does not consider individual deaths disclosable unless they have a material impact on the Company's clinical trials or sales of its product.
The VentrAssist LVAD is used as a therapy for the treatment of seriously ill patients with end stage heart failure with the purpose of prolonging and improving their quality of life. The Company's clinical trial results to date have been outstanding, and met the performance goal specified in the US BTT Clinical Trial. The article also incorrectly states that no VentrAssist devices may be used in Australia.
The Field Safety Notice on the VA166 has not affected the Company's other products such as the LVA3 VentrAssist LVAD, catalogue number VA016, which has been implanted in more than 220 patients worldwide, and remains available for sale in Australia and overseas. Physicians worldwide are continuing to implant the VentrAssist LVAD.