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Teleflex Incorporated (TFX), a leading global provider of medical technologies for critical care and surgery, has recently announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AC3 OptimusTM Intra-Aortic Balloon Pump (IABP).

This device helps a weakened heart pump blood and can deliver IABP therapy to a broad range of patients, even those not previously considered candidates for IABP therapy. Clinicians may use the pump on patients with the most severe arrhythmias or with heart rates as high as 200 beats per minute.

In IABP therapy, a physician inserts an intra-aortic balloon catheter into an artery, and using x-ray or imaging, advances the catheter into the aorta. An IABP console, connected to the catheter, controls the inflation and deflation of the balloon.

“When a patient has an elevated heart rate or severe arrhythmia, his or her survival can suddenly depend on the ability of the IABP to keep pace and provide accurate therapy,” said Kyle Spear, CCP, Chief Perfusionist at a major U.S. medical center. “The AC3 Optimus IABP does this with precision across a wide range of patient conditions.”

The AC3 Optimus IABP has a third-generation AutoPilot® Mode, which uses proprietary algorithms to address key clinical challenges and to simplify the delivery of IABP therapy. In AutoPilot Mode, the AC3 Optimus IABP automatically adjusts timing and triggering parameters, freeing clinicians to focus on the patient rather than the pump. In addition, the AC3 Optimus IABP includes several exclusive algorithms, such as WAVE® Inflation Timing, Deflation Timing Management, and Best Signal Analysis, which optimize key functions of the IABP to deliver therapy to the most challenging patients.

“The AC3 Optimus IABP global launch marks a major milestone for Teleflex. This highly anticipated launch will enable the Company to become a more significant player with a product that can enhance patient outcomes and make it easier for clinicians to deliver IABP therapy,” said Liam Kelly, President and Chief Operating Officer at Teleflex.

The AC3 Optimus IABP will be launched at two key scientific meetings in May. In North America, the AC3 Optimus IABP will be on display at the American Association for Thoracic Surgery and American Society of ExtraCorporeal Technology (AATS/AmSECT) Annual Meeting being held April 29th-May 3rd, 2017 in Boston, MA. Additionally, the AC3 Optimus IABP will be on display at the EuroPCR 2017 Conference being held May 16th-19th in Paris, France. The device has received its CE Mark and has launched in India and parts of Europe.

“As innovators in intra-aortic balloon pumping technology, we continue to advance the performance and reliability of automated therapy to the benefit of patients, clinicians, and health systems everywhere,” said Stewart Strong, President and General Manager of the Interventional Division at Teleflex. “We’ve put everything in to provide a total solution.”

About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch® and Weck® – trusted brands united by a common sense of purpose.

For Further Information
More on the U.S. markets for cardiac surgery and heart valve devices can be found in the 2016 edition report published by iData entitled U.S. Markets for Cardiac Surgery and Heart Valve Devices, which covers market segments for the following: tissue heart valves, mechanical heart valves, annuloplasty repair, transcatheter mitral valve repair, transcatheter heart valve implantation, on-pump coronary artery bypass, off-pump coronary artery bypass, endoscopic vessel harvesting, anastomosis assist, cardiac ablation, transmyocardial revascularization, ventricular assist, intra-aortic balloon pumps, artifical hearts, patent foramen ovale, and atrial and ventricular septal devices.

Recent reports on the markets for cardiac surgery and heart valve devices cover the U.S. and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. Register online or email us at [email protected] for a U.S. Markets for Cardiac Surgery and Heart Valve Devices report brochure and synopsis.

About iData Research
iData Research is an international market research and consulting firm, dedicated to providing the best in business intelligence for the medical device industry. Our research empowers our clients by providing them with the necessary tools to achieve their goals and do it right the first time. iData covers research in: Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Dental Operatory Equipment, Dental Material, Dental Lasers, Dental Prosthetics, Dental CAD/CAM, Dental Bone Graft Substitutes, Ophthalmics, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Vascular Access, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Endoscopy, Anesthesiology, Wound Management, Orthopedics and more.

We have built a reputation and earned our clients’ trust based on consistent and uniquely intelligent research that allows our customers to make confident decisions and impact their businesses. A combination of market expertise and over a decade of experience has resulted in a deep understanding of the medical device industry that has inspired innovation and propelled our clients to success.

About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by state, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.

About Reimbursement Tracker
iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.


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