Teleflex Receives FDA Clearance for the Arrow AC3 Optimus Intra-Aortic Balloon Pump

May 5, 2017—Teleflex Incorporated announced that it has received 510(k) clearance from the US Food and Drug Administration for the company's Arrow AC3 Optimus intra-aortic balloon pump (IABP).

According to Teleflex, the AC3 device can deliver IABP therapy to a broad range of patients, even those not previously considered candidates for IABP therapy. Clinicians may use the pump for patients with the most severe arrhythmias or with heart rates as high as 200 beats per minute.

The AC3 Optimus IABP features a third-generation AutoPilot mode, which uses the company's algorithms to address key clinical challenges and to simplify the delivery of IABP therapy. In AutoPilot mode, the device automatically adjusts timing and triggering parameters, freeing clinicians to focus on the patient rather than the pump. The system also features other algorithms such as Wave inflation timing, deflation timing management, and best signal analysis, which optimize key functions of the IABP to deliver therapy to the most challenging patients.

The AC3 Optimus IABP was introduced at the American Association for Thoracic Surgery and American Society of ExtraCorporeal Technology annual meeting, which was held April 29 to May 3 in Boston, Massachusetts.

In addition, the AC3 Optimus IABP will be on display at the EuroPCR 2017 conference being held May 16–19 in Paris, France. The device has received CE Mark approval and has launched in India and parts of Europe.