Teleflex Gains FDA Clearance for the Innovative AC3 Range™ IABP
Teleflex Achieves 510(k) Clearance for AC3 Range™ IABP
Teleflex Incorporated (NYSE: TFX), a recognized leader in medical technology, has recently announced the FDA 510(k) clearance for its AC3 Range™ Intra-Aortic Balloon Pump (IABP). This innovative device builds upon the advanced technology of the AC3 Optimus™ IABP and is specifically crafted to provide unwavering IABP support for patients during transport across diverse modes, including ambulances and both fixed-wing and rotary-wing aircraft.
Features and Benefits of the AC3 Range™ IABP
The AC3 Range™ IABP uniquely combines a user-friendly interface alongside proprietary algorithms from the AC3 Optimus™ IABP. It ensures precisely timed hemodynamic support tailored for the unique challenges faced during patient transport. Noteworthy features include a full-size helium tank, dual power supply options, a robust extendable handle, and four 360-degree swivel wheels for enhanced maneuverability.
Importance for Cardiac Patients
According to Dr. Christopher Buller, MD, who serves as the Medical Director at Teleflex, “Cardiac patients experiencing significant hemodynamic instability often arrive at smaller healthcare facilities. Yet, they require advanced care typically found at specialized shock centers.” He emphasized the importance of stabilization both prior to and during transport, stating that the AC3 Range™ IABP addresses this critical need by offering a compact solution compatible with popular ground and air ambulances.
Teleflex’s Commitment to Healthcare Advancement
Roger Graham, President and General Manager of Teleflex Interventional, highlighted the company’s nearly four-decade commitment to enhancing intra-aortic balloon pumping technologies. “With the introduction of the AC3 Range™ IABP, we are fulfilling our promise to provide exceptional care in various medical settings, supporting both patients and healthcare professionals in their journey,” he remarked.
Market Release and Upcoming Events
With the recent FDA clearance, Teleflex plans to initiate a full market release of the AC3 Range™ IABP in the United States. Distribution is set to begin in the second quarter of 2025, ensuring that customers have access to this much-anticipated technology. In connection with the product launch, Teleflex will participate in the 45th Annual Meeting & Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT), scheduled for late April. Attendees will have the opportunity to participate in a lunch symposium detailing IABP therapy’s role in cardiac transplant patients and can witness both the AC3 Optimus™ and AC3 Range™ IABP models showcased at booth 623.
About Teleflex Incorporated
As a prominent global provider, Teleflex is driven by its mission to enhance health and quality of life for individuals worldwide. With a vision to become the most reliable partner in the healthcare sector, the company presents a broad range of solutions across various therapeutic areas, including anesthesia, emergency medicine, interventional cardiology, radiology, surgical care, vascular access, and urology. Teleflex believes that the power of passionate individuals, innovative purpose-driven practices, and exceptional products can transform the landscape of healthcare.
The renowned brands associated with Teleflex—such as Arrow™, Barrigel™, Deknatel™, and LMA™—are all unified under this shared commitment to care quality. Teleflex empowers the evolution of healthcare delivery, advocating for improved practices and patient outcomes. For further details about Teleflex and its offerings, please visit teleflex.com.
Frequently Asked Questions
1. What is the AC3 Range™ IABP?
The AC3 Range™ IABP is a device designed to provide intra-aortic balloon pumping support for cardiac patients during transport.
2. How does the AC3 Range™ IABP improve patient care?
This device offers reliable support across different transportation modes, enhancing stabilization prior to and during patient transport.
3. When will the AC3 Range™ IABP be available in the market?
The full market release is set to begin in the United States in the second quarter of 2025.
4. What features make the AC3 Range™ IABP unique?
It includes a full-size helium tank, dual power options, a robust handle, and swivel wheels for better maneuverability.
5. Who is the manufacturer of the AC3 Range™ IABP?
Teleflex Incorporated, a global provider of medical technologies, is the manufacturer of the AC3 Range™ IABP.
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