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Teleflex Receives FDA Clearance for Expanded Indication for Specialty Catheter and Coronary Guidewire Use in CTO PCI Procedures

Results of CTO-PCI IDE study demonstrate procedural success with Teleflex specialty catheters and coronary guidewires in patients undergoing chronic total occlusion percutaneous coronary interventions. ....

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Teleflex Receives FDA Clearance for Expanded Indication for Specialty Catheter and Coronary Guidewire Use in CTO PCI Procedures

Press release content from Globe Newswire. The AP news staff was not involved in its creation. ....

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Teleflex Completes Enrollment in CTO-PCI IDE Study

Teleflex Completes Enrollment in CTO-PCI IDE Study
Enrollment Completed Ahead of Schedule in Study Evaluating the Performance of Teleflex Specialty Catheters and Coronary Guidewires in Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Interventions
WAYNE, Pa., Feb. 17, 2021 (GLOBE NEWSWIRE) Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the completion of patient enrollment in a clinical study evaluating the performance of Teleflex specialty catheters and coronary guidewires in Chronic Total Occlusion (CTO) percutaneous coronary intervention (PCI) procedures currently an investigational indication for these products. The study enrolled 150 patients across 13 investigational sites in the US and completed enrollment three months ahead of schedule. The CTO-PCI study is a prospective, single-arm IDE study employing the primary angiographic endpoint of successful (intralumenal) guidewire placement beyond th ....

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