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Medical Devices / Submissions and Approvals

Pavmed’s Carpal Tunnel Treatment Sees Successful Use in Resubmission Safety Study

Aug. 16, 2019
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Pavmed announced that procedures for its carpal tunnel syndrome device, CarpX, were successful in all 20 patients of its first-in-human clinical safety study.

The clinical safety study is being conducted as part of the devicemaker’s 510(k) resubmission for the minimally invasive device, which uses catheters, balloons, radiofrequency energy and other means to treat the condition.

“PAVmed will resubmit the CarpX 510(k) application incorporating the clinical safety and effectiveness data from the study once 90-day follow-up is completed in all 20 patients,” the company said.

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