Um, me think ya putting the wind up ya selves unnecessarily so. Refer back to the announcement on the 12 March ‘ 09…
EXTRACT
The Data and Safety Monitoring Board (DSMB) met to review the clinical data, and
concluded that the VentrAssist LVAD has met the performance goal in the BTT Trial.
Furthermore, adverse event rates were reviewed by the DSMB, and were felt to be
consistent with the published rates for similar populations and devices, and markedly
improved over first generation pulsatile LVADs.
The key here is the Data and Safety Monitoring Board (DSMB), an independent body evaluating the safety of the product -
DSMB
and a couple of others to read in union…
ICSSC
PRESENTATIONS
A quack would definitely not be receptive to using a product that is not up to standard knowing their liabilities would be out of this world if they knowingly and deliberately use a defective product e.g. struck off the medical register, IDE exemption or not; left penniless and the worst scenario slammed in the jammer for manslaughter.
Thus, the issue with the leads is one of many components within the Adverse Event Rate assessment. Like all manufacturers they have a risk tolerance assessment with so call quality control. Bottom line their risk-based assessment didn’t come up to scratch. They forgot how fickle the human element is, unpredictable; the variable. So it’s go back to the drawing board and re-assess the risk-based percentile, in other words better materials/configuration; in conjunction with better instruction and training for receiptants.
At the end of the day FDA is allowing DT & BTT under CAP to continue, for them it’s not an issue. For the board a convenience with TGA?
VCR
ventracor limited
