Teleflex: Teleflex announces US FDA clearance for AC3 Range intra-aortic balloon pump

Teleflex has announced US Food and Drug Administration (FDA) 510(k) clearance of the AC3 Range intra-aortic balloon pump (IABP). Leveraging the patented technology of the AC3 Optimus IABP, the AC3 Range IABP is designed to provide reliable, ongoing IABP support across various patient transport modes, including ambulances and both fixed- and rotary-wing aircrafts, Teleflex says in a press release. The AC3 Range IABP combines the simple interface and proprietary algorithms of the AC3 Optimus IABP to deliver the same support with features designed specifically for challenges unique to transport, including a full-size helium tank, dual power options, a metal-reinforced extendable handle, and four 360-degree swivel wheels for manoeuvrability. "Cardiac patients with life-threatening haemodynamic instability often present to smaller hospitals yet benefit from care at shock centres," said Christopher Buller, medical director, Teleflex. "Stabilisation prior to and during transport is critical, and the AC3 Range intra-aortic balloon pump helps address this need with a compact pump compatible with commonly used ground and air ambulance vehicles." "For nearly 40 years, Teleflex has been committed to advancing intra-aortic balloon pumping, delivering cardiac support for critically ill patients," said Roger Graham, president and general manager, Teleflex Interventional. "With the AC3 Range IABP, we extend this commitment across care settings, serving patients throughout their care journey and supporting the health care providers who depend on this technology in the field." With the 510(k) clearance, the AC3 Range IABP will enter full market release in the USA and will begin shipping to customers in the second quarter of 2025.