Teleflex receives FDA 510(k) Clearance for its Arrow AC3 Optimus intra-aortic balloon pump


Teleflex has announced 510(k) clearance from the FDA for its AC3 Optimus intra-aortic balloon pump (IABP). A press release reports that device helps a weakened heart pump blood and can deliver IABP therapy to a broad range of patients, even those not previously considered candidates for IABP therapy. Clinicians may use the pump on patients with the most severe arrhythmias or with heart rates as high as 200 beats per minute.

The AC3 Optimus IABP has a third-generation AutoPilot Mode, which uses proprietary algorithms to address key clinical challenges and to simplify the delivery of IABP therapy. In AutoPilot Mode, the AC3 Optimus IABP automatically adjusts timing and triggering parameters, freeing clinicians to focus on the patient rather than the pump. In addition, the AC3 Optimus IABP includes several exclusive algorithms, such as WAVE Inflation Timing, Deflation Timing Management, and Best Signal Analysis, which optimise key functions of the IABP to deliver therapy to the most challenging patients.

“The AC3 Optimus IABP global launch marks a major milestone for Teleflex. This highly anticipated launch will enable the Company to become a more significant player with a product that can enhance patient outcomes and make it easier for clinicians to deliver IABP therapy,” said Liam Kelly, president and chief operating officer at Teleflex.

The AC3 Optimus IABP will be on display at EuroPCR (16–19 May, Paris, France). The device has received its CE Mark and has launched in India and parts of Europe.