FDA approves Abiomed Impella for treating right heart failure - Mass Device

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

Abiomed (Nasdaq:ABMD) announced contiguous that the FDA granted its Impella RP Flex with SmartAssist pre-market support (PMA).

Danvers, Massachusetts-based Abiomed designed the Impella RP Flex with SmartAssist to dainty close bosom failure. It does truthful for up to 14 days. The institution intends to present Impella RP Flex successful the U.S. done a controlled motorboat this quarter.

The FDA indicated Impella RP Flex with SmartAssist for providing impermanent close ventricular enactment for up to 14 days successful patients with a assemblage aboveground country ≥1.5 m². These patients make acute close bosom nonaccomplishment oregon decompensation pursuing near ventricular assistance instrumentality implantation, myocardial infarction, bosom transplant, oregon open-heart surgery.

Patients person the Impella RP Flex via implant into the interior jugular (IJ) vein. This enables diligent mobility, according to a quality release. The bosom pump besides features dual-sensor exertion for optimizing diligent management, Abiomed said.

Impella RP includes the world’s smallest percutaneous close bosom mechanical circulatory enactment (MCS) technologies, Abiomed said. The institution designed these technologies to assistance patients execute autochthonal bosom recovery. They don’t necessitate extracorporeal humor circulation.

Abiomed said its MCS technologies correspond the lone specified offerings with FDA PMA indications for treating close bosom failure.

“Impella RP Flex demonstrates Abiomed’s ongoing committedness to improving diligent endurance and achieving autochthonal bosom recovery,” said Dr. Mark B. Anderson, seat of the section of cardiac country and cardiothoracic surgeon astatine the Heart and Vascular Hospital astatine HUMC/Hackensack Meridian Health.

About Impella RP Flex with SmartAssist

Impella RP Flex features azygous venous entree done the IJ vein with an 11 French (Fr) indwelling catheter. This facilitates diligent mobility, Abiomed said.

Additionally, it designed the level with flexible cannula precocious implicit an extra-support guidewire. The institution said it enables 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.

Study information demonstrated importantly higher endurance complaint successful those who received Impella RP enactment compared to those who received delayed right-heart support. Within 48 hours of cardiogenic daze onset, Impella RP patients registered a 73% endurance rate. Those who received delayed enactment survived astatine conscionable a 14% clip.

“The complexity of close ventricular nonaccomplishment has resulted successful patients being underdiagnosed and undertreated,” said Dr. Robert Salazar, an interventional cardiologist and manager of cardiovascular probe astatine Kingwood Medical Center. “Impella RP Flex is simply a caller instrumentality that gives physicians the flexibility to dainty this challenging diligent population.”