Teleflex Gets FDA 510(k) Clearance For Arrow AC3 Optimus IABP

(RTTNews) - Teleflex Inc. (TFX), a provider of medical technologies for critical care and surgery, announced 510(k) clearance from the U.S. Food and Drug Administration for its AC3 Optimus Intra-Aortic Balloon Pump or IABP.

The 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.1, 2

In IABP therapy, a physician inserts an intra-aortic balloon catheter into an artery, and using x-ray or imaging, advances the catheter into the aorta. An IABP console, connected to the catheter, controls the inflation and deflation of the balloon.