Critical care and surgery device company Teleflex Inc., has announced U.S. FDA 510(k) clearance for its AC3 Optimus™ Intra-Aortic Balloon Pump (IABP).
Background
Teleflex offers a diverse portfolio of solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. The company boasts brands such as Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch® and Weck®.
Teleflex’s AC3 Optimus Intra-Aortic Balloon Pump 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. The procedure involves insertion of an intra-aortic balloon catheter into an artery, and using x-ray or imaging, advancement of the catheter into the aorta. An IABP console, connected to the catheter, controls the inflation and deflation of the balloon.
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 device features 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 will be launched at two key scientific meetings in May. In North America it 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. It will be on display at the EuroPCR 2017 Conference being held May 16th-19th in Paris, France. The device is CE Marked and has launched in India and parts of Europe.
Physician comments
“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 and a consultant to the company. He added ; “The AC3 Optimus IABP does this with precision across a wide range of patient conditions.”
Company comments
“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.
“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.”
Source: Teleflex, Inc.
published: May 8, 2017 in: Approval/Clearance, Cardio