Abiomed's Latest Regulatory Progress Boosts Impella Line

Abiomed Inc.’s (NASDAQ:ABMD) flagship Impella product line shines bright on the receipt of pre-market approval from the FDA for its Impella RP heart pump. Notably, Impella RP is the only FDA-cleared percutaneous temporary ventricular support device available in the market.

The Impella RP System has been exclusively formulated to provide temporary right ventricular support to patients with acute right heart failure or decompensation. Its important to note that, the device does not involve any sort of surgical procedure for insertion. In fact, Impella RP provides more than four liters of blood per minute to provide hemodynamic support to patients.

Per management, the latest regulatory go ahead eradicates the risks associated with Right Ventricular Failure (RVF). These risks include increased mortality, longer lengths of stay in the intensive care unit and end-organ dysfunction.

We believe that robust demand for Impella products will continue to drive Abiomed’s top line over the long term. Notably, Impella line has other FDA-approved products like Impella 2.5, Impella CP and Impella 5.0. This business line is exclusively designed to treat patients in cardiogenic shock or undergoing elective and urgent percutaneous coronary interventions (PCI). Evidently, Impella heart pump’s global revenues grew a strong 30% in the last quarter.

Bottom Line

Lately, management at Abiomed has made significant investments in training and data collection procedures from Impella platform. The Impella line has been gaining prominence in the international ventricular-assist devices markets as well. The company’s continued progress in countries like Germany and Japan, leveraging on the Impella line, is worth a mention.

Data from Research And Markets suggests that the ventricular-assist devices global market is set to reach a worth of $2.8 billion by 2023. Meanwhile, the company faces stiff competition from organizations developing permanent heart assist products like Teleflex Inc. (NYSE:TFX) , Abbott Laboratories (NYSE:ABT) and Fresenius Medical Care (NYSE:FMS) .

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