FDA OKs Teleflex’s AC3 Range Intra-Aortic Balloon Pump

Teleflex has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its AC3 Range intra-aortic balloon pump (IABP).

The AC3 Range IABP merges the interface and proprietary algorithms of the AC3 Optimus IABP to deliver precisely timed support, with features designed for challenges unique to transport. These include a full-size helium tank, dual power options, a metal-reinforced extendable handle, and four 360-degree swivel wheels.

The new IABP is designed for reliable, ongoing IABP support across patient transport modes, including ambulances and both fixed- and rotary-wing aircrafts.

“Cardiac patients with life-threatening hemodynamic instability often present to smaller hospitals yet benefit from care at shock centers,” said Dr. Christopher Buller, MD, Medical Director, Teleflex. “Stabilization 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.”

Given the FDA nod, the AC3 Range IABP will begin full U.S. market release and start shipping to customers in Q2 2025.

“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.”

In February, the company announced that it plans to separate its Urology, Acute Care, and OEM businesses in to a new, independent, publicly traded company.