Two things went wring with TMR: aggressive drug regimens took away a lot of the urgent demand, and medical division of labor delivered candidates first to physicians who were more inclined to use stents if the drugs weren't enough (and boy, did they over-use stents).
There are no such threats against RG. Best guesses at CIN prevention have failed. The potential patients are delivered first to the ones who have the choice whether to use RG. MUCH easier marketing exercise, and visibly so. It doesn't hurt that CIN is a malpractice lawyer's happy dream: nothing sways a jury like a patient able to testify about slow death in progress. The thing WILL be used if the evidence stays good.
I'm a little concerned about the solidity of the patents. No data, but these guys have messed up in the past.
There have been noises about making the device approval process more onerous. I think our legislators are focusing on other fights these days, and FDA seems unlikely to move quickly unless shoved. It's interesting that the rule of thumb is that to get a drug from the stage RG is at through to US marketing you'd need $100MM, while for a device $6MM looks about right.