Teleflex Receives FDA 510(k) Clearance of the AC3 Range™ Intra-Aortic Balloon Pump (IABP)

By: Teleflex Incorporated via GlobeNewswire

April 01, 2025 at 06:30 AM EDT

WAYNE, Pa., April 01, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced 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.

The AC3 Range™ IABP combines the simple interface and proprietary algorithms of the AC3 Optimus™ IABP to deliver the same precisely timed support¹ 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 maneuverability.

“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.”

"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 United States and will begin shipping to customers in the second quarter of 2025.

Teleflex will be attending the 45th Annual Meeting & Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT) April 27-30 in Boston, MA. As part of the event, Teleflex will host a lunch symposium exploring the role of IABP therapy in cardiac transplant patients. Attendees can also visit Teleflex booth 623 to see both the AC3 Optimus™ and AC3 Range™ IABPs on display.

About Teleflex

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Reference

Donelli A, Jansen JRC, Hoeksel B, et al. Performance of a real-time dicrotic notch detection and prediction algorithm in arrhythmic human aortic pressure signals. J Clin Monit. 2002;17(3-4):181-185. Study sponsored by Teleflex.

CAUTION: Federal (USA) law restricts these devices for sale or use by or on the order of a physician.

Teleflex, the Teleflex logo, AC3 Optimus, AC3 Range, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries. Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings, and precautions. Information in this document is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative.

Contacts:

For Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610.948.2836