WAYNE, PA — Teleflex Incorporated (NYSE: TFX) has announced that its AC3 Range™ Intra-Aortic Balloon Pump (IABP) has received FDA 510(k) clearance. Designed for seamless intra-aortic balloon pumping across various modes of patient transport, including ambulances and both fixed- and rotary-wing aircraft, the AC3 Range™ IABP represents a significant advancement in critical care technology.
The AC3 Range™ IABP builds on the foundation of Teleflex’s patented AC3 Optimus™ IABP technology. It incorporates a simple interface and proprietary algorithms to deliver precisely timed support while introducing transport-specific features. The device includes a full-size helium tank, dual power options to ensure continuous operation, a metal-reinforced extendable handle for durability, and 360-degree swivel wheels to enhance mobility in demanding environments.
“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.”
Revolutionizing Cardiac Crisis Solutions
With nearly four decades of experience in advancing intra-aortic balloon pump technology, Teleflex is addressing gaps in critical cardiac care. The AC3 Range™ IABP is specifically tailored to provide support throughout a patient’s care pathway, particularly during transport between facilities. This innovation is expected to benefit both rural hospitals and specialized shock centers that depend on stabilization technologies during critical cardiac episodes.
Roger Graham, President and General Manager of Teleflex Interventional, emphasized the company’s dedication to supporting healthcare professionals in diverse settings. “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,” said Graham.
Preparing for Market Rollout
Now cleared for market release, the AC3 Range™ IABP will begin shipping to U.S. customers in the second quarter of 2025, further expanding access to life-saving cardiac technology. The approval positions Teleflex to continue its mission of delivering innovative cardiac support solutions to meet the evolving needs of patients and healthcare providers.
Spotlight at ISHLT 2025
The AC3 Range™ IABP will also take center stage at the 45th Annual Meeting & Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT) from April 27-30 in Boston, MA. Teleflex will host a dedicated lunch symposium exploring the role of IABP therapy in cardiac transplant patients. Visitors to Teleflex’s booth (#623) will have an opportunity to see both the AC3 Optimus™ and AC3 Range™ IABPs on display, showcasing the latest innovations in cardiac care.
A New Standard in Cardiac Transport
The introduction of the AC3 Range™ IABP underscores Teleflex’s leadership in cardiovascular technology, with a focus on enhancing outcomes for critically ill patients during every stage of care. Its compact design, easy maneuverability, and compatibility with ground and air transportation make it a vital tool for addressing the demands of modern cardiac transport.
With the backing of FDA clearance and a strong history of innovation, Teleflex is poised to elevate the standard of critical care for cardiac patients, reinforcing its commitment to advancing life-saving technologies in complex healthcare environments.
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