Teleflex has announced 510(k) clearance from the US Food and Drug Administration (FDA) for its AC3 Optimus Intra-Aortic Balloon Pump (IABP).This 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. According to the company, clinicians may use the pump on patients with the most severe arrhythmias or with heart rates as high as 200 beats per minute.
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.
“When a patient has an elevated heart rate or severe arrhythmia, his or her survival can suddenly depend on the ability of the IABP to keep pace and provide accurate therapy,” says Kyle Spear, Chief Perfusionist in USA. “The AC3 Optimus IABP does this with precision across a wide range of patient conditions.”
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 device has received its CE mark and has launched in India and parts of Europe.