Teleflex wins FDA nod for intra-aortic balloon pump

Teleflex (NYSE: TFX)+ announced today that it received FDA 510(k) clearance for its AC Range intra-aortic balloon pump (IABP).

The AC3 Range IABP joins the company’s expanding portfolio of IABPs, including the AC3 Optimus. Teleflex designed them to provide reliable, ongoing IABP support across various patient transport modes. That includes ambulances and fixed- and rotary- wing aircrafts.

Wayne, Pennsylvania-based Teleflex combined the simple interface and proprietary algorithms of AC3 Optimus within AC3 Range. This delivers the same precisely timed support with features designed specifically for challenges unique to transport. Those include a full-size helium tank, dual-power options, a metal-reinforced extendable handle and four 360-degree swivel wheels.

“Cardiac patients with life-threatening hemodynamic instability often present to smaller hospitals yet benefit from care at shock centers,” said Dr. Christopher Buller, medical director, Teleflex. “Stabilization prior to and during transport is critical, and the AC3 Range IABP helps address this need with a compact pump compatible with commonly used ground and air ambulance vehicles.”

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