Teleflex wins FDA nod for Arrow AC3 Optimus IABP

Teleflex (NYSE:TFX) said today it won FDA 510(k) clearance for its Arrow AC3 Optimus intra-aortic balloon pump.

The device is designed to help weakened hearts pump blood and can deliver IABP therapy to a broad range of patients, including candidates who had previously not been considered for IABP therapy, the Wayne, Penn.-based company said.

“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,” prez & COO Liam Kelly said in a press release.

The AC3 Optimus is equipped with a 3rd-generation AutoPilot mode which uses algorithms to simplify the delivery of IABP therapy, the company said. The device also includes other capabilities and algorithms, including Wave inflation timing, deflation timing management and best signal analysis.

“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. The AC3 Optimus IABP does this with precision across a wide range of patient conditions,” Kyle Spear said in prepared remarks.

Teleflex said that the AC3 Optimus will be launched this month, and on display at the American Association for Thoracic Surgery and American Society of ExtraCorporeal Technology’s annual meetings.

“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. We’ve put everything in to provide a total solution,” interventional division GM & prez Stewart Strong said in a prepared statement.

Last month, Teleflex said it closed its $6 million acquisition of Pyng Medical (CVE:PYT), making Pyng a subsidiary of Teleflex Canada.

Teleflex paid 30.2¢ apiece for the roughly 28.5 million shares in Pyng, which makes intraosseous infusion technology, pelvic stabilization & emergency tourniquet devices. Pyng shareholders approved the takeover a week prior. The Supreme Court of British Columbia approved the deal March 29, the companies said.

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