US-based medical device company Teleflex has received the US Food and Drug Administration (FDA) 510(k) clearance for its AC3 Range Intra-Aortic Balloon Pump (IABP).
Designed based on the company’s AC3 Optimus IABP, AC3 Range IABP provides reliable support across various patient transport modes, including ambulances and aircraft.
The AC3 Range IABP integrates the AC3 Optimus IABP’s simple interface and unique algorithms, with features customised to meet the unique challenges of patient transport.
Teleflex medical director Christopher Buller said: “Cardiac patients with life-threatening hemodynamic instability often present to smaller hospitals yet benefit from care at shock centres.
“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.”
The AC3 Range IABP features a full-size helium tank, dual power options, a metal-reinforced extendable handle, and four 360-degree swivel wheels for manoeuvrability.
It offers a low cost of ownership, featuring a pneumatic drive system with no scheduled replacement parts and low component replacement costs.
With the FDA approval, Teleflex is planning for full market release of the AC3 Range IABP in the US, with shipments expected to commence in the second quarter of 2025.
Teleflex interventional president and general manager Roger Graham said: “For nearly 40 years, Teleflex has been committed to advancing intra-aortic balloon pumping, delivering cardiac support for critically ill patients.
“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.”
Earlier this year, Teleflex agreed to acquire the Vascular Intervention business of German firm BIOTRONIK for approximately €760m.
The acquisition will broaden Teleflex’s portfolio, adding drug-coated balloons, drug-eluting stents, covered stents, balloon and self-expanding stents, and balloon catheters.
Furthermore, Teleflex has announced plans to separate its urology, acute care, and OEM businesses into a new, independent, publicly traded company.
