Abiomed has secured pre-market approval (PMA) approval from the US Food and Drug Administration (FDA) for its Impella RP with SmartAssist device to treat acute right heart failure for up to 14 days.
The next generation Impella RP device is claimed to be the first single-access temporary percutaneous ventricular support device with dual-sensor technology.
The FDA indication allows Impella RP with SmartAssist system to offer temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2.
It is indicated for patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
Impella RP with SmartAssist is an advanced version of the Impella RP device, which received PMA approval from FDA in 2017.
Designed for a simplified setup and insertion, the Impella RP with SmartAssist offers real-time guidance and trends for efficient pump management and weaning.
The device is integrated with Impella Connect to facilitate remote monitoring from any internet-connected device via a secure and HIPAA-compliant website.
Memorial Hermann Health System Northeast Hospital and Kingwood Medical Centre interventional cardiologist Dr Robert Salazar said: “Impella RP with SmartAssist further improves an incredibly valuable tool to treat right heart dysfunction.
“The addition of SmartAssist technology to Impella RP is an important advancement to help physicians achieve even better patient outcomes with an improved design and intuitive metrics.”
Abiomed is also offering SmartAssist technology on Impella CP and Impella 5.5 for management of left heart failure and early detection of right heart failure.
In June last year, the company also secured an emergency use authorisation from the FDA for Impella RP to treat patients with Covid-19-related right heart failure or decompensation including pulmonary embolism (PE).
Earlier this month, Abiomed acquired a medical device company preCARDIA, which offers heart failure specialists a minimally invasive solution to enhance patient outcomes and reduce the cost of care.
