In short
Late last week, an expert panel voted to classify non-roller type cardiopulmonary pumps as Class III high risk devices. This means one particular product, Abiomed’s Impella, previously allowed through under 510(k) special controls rules, will need to be resubmitted for a PMA. The company will be allowed to continue marketing the product in the interim.
Backgound
The rules according to which the FDA approves or clears products for marketing are under constant review, as devices emerge which don’t sit comfortably in the current classification framework. The review process is a formal affair involving expert panels and the FDA in what is called a 515(i), referring to this particular provision in the legislature.
In this case, 515(i) was instigated in order to correct an old amendment from 1976, under which devices such as Abiomed’s Impella device had gained market access by being allowed to go down the 510(k) route. The deliberation was provoked by the curious distinction that had existed between pump types, FDA having made a regulatory distinction between conventional roller pumps and the non-roller-type cardiopulmonary bypass pumps (NRPs) such as Impella. While both were Class III, high risk devices, the NRP type had retained the right to go down the 510(k) route because of the old amendment.
Despite Abiomed making its representations in support of its device, which included reference to its PROTECT II study data, the FDA confirmed its briefing guidance, issued earlier in the week. This now means Abiomed will have to embark on a PMA for its product. Luckily, it seems the company is confident it has already amassed a fair old pile of clinical support for its Impella family, which it will now need to put in front of the FDA as the parties establish what needs to happen next. The company’s share price took a tumble on the news, dropping a dollar to $12 at one point, before recovering to $12.6o by the end of play.
Quite why any heart pump would not be allowed through without the stype of scrutiny required by a PMA is an interesting question in itself. In the case of Impella, while it may not be logical to consider it as identical in function to a roller type pump, this sort of pump does have a bunch of risks all of its own as identified by the FDA. Operating as it does within the blood flow, the device introduces the risk that it could provoke alteration in blood composition, inadequate tissue perfusion, embolism, problems related to duration of use, fluid leakage, adverse tissue reaction and infection. For the temporary ventricular support indication, the risks also include structural/tissue damage to the heart, local heat generation and problems with flow dynamics. All of which sound like it might be hard to argue that these albeit clever devices truly represent a lower risk.
Company comments
Abiomed’s Chairman and Chief Executive, Michael Minogue said; “We welcome the opportunity for a PMA to strengthen our existing marketing clearances and expand the indications for Impella patients.”
Said through gritted teeth perhaps, but at least it’s all clear now.
Abiomed’s press release on the 515(i) can be found here.
Source: Abiomed
published: December 10, 2012 in: Cardio, Regulatory