https://www.mddionline.com/fda-says-patient-selection-key-ab…
As per below excerpt, the size of the patient trial group is rather small. Stock getting a welcome little lift from these current lows in response to this news.
"FDA Says Patient Selection is Key to Abiomed Impella RP Safety
FDA urged doctors on Tuesday to read and follow the revised labeling for Abiomed’s Impella RP System, which includes a patient selection checklist to understand which patients may benefit most from treatment with the device. The benefits Abiomed’s Impella RP System outweigh the risks of the device, but only if it is used for the currently approved indication in appropriately selected patients, according to FDA’s latest letter about the device.
FDA said the latest interim results indicate a lower survival rate for the subgroup of post-approval study patients who would not have qualified for the premarket clinical studies compared to the premarket clinical study survival rate.
The agency reported that the most recent post-approval study report shows 12 out of the 42 patients (28.6%) survived to 30 days post device explant or hospital discharge, or to the start of longer-term therapy. In the premarket studies, the survival rate was 73.3% "