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

Rhea-AI Summary

Teleflex (NYSE: TFX) has received FDA 510(k) clearance for its new AC3 Range™ Intra-Aortic Balloon Pump (IABP). This innovative medical device is specifically designed for patient transport across various modes, including ambulances and aircraft.

The AC3 Range™ IABP builds upon the patented technology of the AC3 Optimus™ IABP, featuring a simple interface and proprietary algorithms for precise cardiac support. Key transport-focused features include:

• Full-size helium tank
• Dual power options
• Metal-reinforced extendable handle
• Four 360-degree swivel wheels

The device will enter full market release in the United States with shipments beginning in the second quarter of 2025. Teleflex will showcase both the AC3 Optimus™ and AC3 Range™ IABPs at the upcoming ISHLT Annual Meeting in Boston.

Positive

• FDA 510(k) clearance received for new medical device
• Product launch in Q2 2025 expands cardiac support portfolio
• Enhanced transport capabilities address unmet medical need
• Builds upon existing successful technology platform

Negative

• None.

Insights

Medical Device Expert

The FDA 510(k) clearance of Teleflex's AC3 Range™ IABP represents a significant technological advancement in critical cardiac care mobility. This device addresses a crucial gap in the care continuum for hemodynamically unstable cardiac patients who initially present at community hospitals but require transfer to specialized cardiac centers.

The adaptation of their established Optimus platform for transport scenarios shows smart iteration rather than ground-up redesign, incorporating essential features like dual power options, full-size helium tanks, and reinforced mobility components. These features directly address the unique challenges of maintaining precise intra-aortic balloon counterpulsation during patient transport.

From a clinical perspective, this device potentially improves outcomes by maintaining consistent cardiac support during the vulnerable transport period when patients historically might experience support interruptions or suboptimal therapy. The timing algorithms carried over from their stationary model provide the hemodynamic augmentation precision critical for unstable patients.

This clearance fits within the broader trend of extending sophisticated critical care technologies beyond fixed hospital settings. While incremental rather than revolutionary, this transport-capable IABP fills a specific unmet need in the cardiac critical care pathway with substantial clinical value for a targeted but important patient population.

Healthcare Investment Analyst

Teleflex's 510(k) clearance for the AC3 Range™ IABP strengthens their position in the cardiac support device market with a strategic product line extension. By targeting the transport segment, Teleflex is addressing a specialized niche with less competition than the general hospital IABP market.

The company has leveraged their 40-year experience in IABP technology to create a differentiated offering that capitalizes on existing R&D investments while opening new customer segments in transport medicine and regional cardiac networks. This approach typically offers higher ROI than entirely new product development.

With commercialization set for Q2 2025, this adds a near-term catalyst to Teleflex's product cycle. While the market size for transport-specific IABPs isn't disclosed, this product fits Teleflex's strategy of focusing on specialized medical technology with strong clinical utility rather than commodity devices.

Particularly valuable is how this product reinforces Teleflex's full-continuum care approach, potentially creating pull-through sales opportunities when transport teams and destination hospitals standardize on Teleflex's balloon catheter systems. The clearance also demonstrates continued execution on their regulatory pathway and innovation pipeline, important quality indicators for medical device companies.

The addition to the IABP family supports uncompromised cardiac support for patients during transport

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

1. 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.

© 2025 Teleflex Incorporated. All rights reserved. MC-010652 Rev 0.

Contacts:

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

FAQ

When will Teleflex (TFX) begin shipping the new AC3 Range IABP to US customers?

Teleflex will begin shipping the AC3 Range IABP to US customers in Q2 2025 following its FDA 510(k) clearance.

What are the key transport features of Teleflex's (TFX) new AC3 Range IABP?

The AC3 Range IABP features a full-size helium tank, dual power options, metal-reinforced extendable handle, and four 360-degree swivel wheels for transport versatility.

Which transport modes are compatible with Teleflex's (TFX) AC3 Range IABP?

The AC3 Range IABP is compatible with ambulances, fixed-wing aircraft, and rotary-wing aircraft for patient transport.

How does the new TFX AC3 Range IABP differ from the AC3 Optimus IABP?

While utilizing the same patented technology and algorithms as the AC3 Optimus, the Range model adds specific features for transport scenarios while maintaining the same precise cardiac support.