Based on the banter on that Board, there are some very unhappy...

Based on the banter on that Board, there are some very unhappy reps working at Integra. As well as growing recognition of BTM…

I notice that, in late 2018, one of the reps defended Integra’s products against BTM, arguing that BTM was unproven

.......how can anyone implant a fully synthetic device such as this while knowing 0 about the response it will elicit from the human body in 10 yrs? Heck, 5 yrs??......these types of sythentic wound care 510k cleared products are not evaluated based on their OWN long term, scientific, objective, RCT’s

The rep’s argument against use of BTM would seem to be based on valid concerns and one would imagine that, in the field, these arguments have been used by Integra reps to attempt to dissuade doctors from ditching Integra’s product in favour of Novosorb BTM.

However, the argument that BTM shouldn’t be used because it is 510(k)-, rather than PMA- approved, doesn’t quite stack up if one considers the fact that Integra also promotes and sells PriMatrix dermal repair scaffold products; yet these products are 510(k) approved.

Also, the expressed concern that there is zero evidence about the response that the BTM device will elicit from the body in 10, or even 5 years’ time also seems somewhat disingenuous to me.

Firstly, BTM is not a permanent synthetic mesh: it’s fully resorbable and gone without trace in less than 5 years.

The claim that there is zero knowledge of the body’s response to BTM after 5 years is also inaccurate. BTM has now been in use in humans since 2012 and several human trials have already been completed. A free flap donor site trial was commenced in 2012 and results have been published. In addition, the CE Mark trial, a prospective study of BTM in deep burns which was commenced in 2015 and completed last year will have results published later this month. Also due this month are published results from the initial feasibility (assessment of safety and effectiveness) study of BTM in deep burns, which was commenced by BARDA in 2016.

A study to assess the long-term safety and performance of patients previously treated with NovoSorb BTM is registered and due to commence shortly in Australia, while a further US study to assess the safety and effectiveness of NovoSorb BTM in the treatment of severe burn skin injuries is due to commence in May. If successful, this pivotal study, which is fully funded by BARDA, should lead to PMA approval by the FDA for use of BTM in third degree burns.

It will take many years to accumulate the quantity of data on BTM which is available for Integra’s Dermal Regeneration template – its application for PMA approval for treatment of deep burns was first submitted to the FDA 30 years ago and was finally approved in 1996. But, the evidence for the safety and efficacy of Novosorb BTM is slowly building.