FDA tightens indications for Abiomed Impella RP system - Mass Device

The Impella RP Flex with SmartAssist. [Image from Abiomed]

The FDA announced contiguous that it is updating the labeling connected Abiomed‘s Impella RP Flex with SmartAssist to bespeak the last post-approval survey results.

Abiomed announced successful October that FDA had approved the catheter-delivered bosom pump strategy to supply impermanent close ventricular enactment for up to 14 days. People tin make acute close bosom nonaccomplishment oregon decompensation pursuing near ventricular assistance instrumentality implantation, myocardial infarction, bosom transplant, oregon open-heart surgery.

Now, the FDA has updated the labeling (changes successful italics):

“The Impella RP System is indicated for providing impermanent close ventricular enactment for up to 14 days successful patients with a assemblage aboveground country ≥1.5 m², who make acute close bosom nonaccomplishment oregon decompensation for little than 48 hours pursuing near ventricular assistance instrumentality implantation, myocardial infarction, bosom transplant, oregon open-heart surgery, without the beingness of profound shock, extremity organ failure, oregon acute neurologic injury.”

According to the FDA, patients successful the post-approval survey who would person met the enrollment criteria for the premarket objective studies showed a akin endurance rate. The FDA said 23 retired of 33 evaluable patients (69.7%) survived to 30 days aft the instrumentality explant oregon infirmary discharge — oregon to the commencement of the adjacent longer-term therapy.

However, the endurance complaint was overmuch little — 18.6%, oregon 13 retired of 70 evaluable patients — among those who would not person qualified for the premarket study. The patients who would not person qualified were much apt to person been successful acute close bosom nonaccomplishment oregon decompensation for longer than 48 hours. In addition, they whitethorn person experienced a terrible cardiogenic shock, end-organ failure, oregon acute neurologic injury.

As a result, the FDA updated the tightened the indications successful the labeling. It said it volition proceed to enactment with Abiomed to show reports of adverse events and support wellness providers informed.

More astir Abiomed’s Impella RP Flex with SmartAssist

The Impella RP Flex features azygous venous entree done the IJ vein with an 11 French (Fr) indwelling catheter. According to Abiomed, the plan enables amended diligent mobility.

In addition, Abiomed included a flexible cannula precocious implicit an extra-support guidewire. The extremity is some easiness of insertion and pump delivery.

The SmartAssist dual-sensor exertion combines with Impella Connect to present precocious metrics for pump absorption and weaning. Abiomed besides developed a heparin-free purge to simplify diligent anticoagulant management. Sodium bicarbonate is utilized wherever heparin is of interest owed to heparin intolerance oregon bleeding.