Covidien's DVT compression system gets FDA green light
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Covidien's Kendall SCD sequential compression comfort sleeve and Kendall SCD 700 series controller. The devices are designed to reduce the incidence of deep vein thrombosis (DVT) and pulmonary embolism, while avoiding the risk of bleeding found with anticoagulant drugs. The device is more comfortable than older systems, Mansfield, Massachusetts-based Covidien says, and addresses problems such as sweating, heat, itchiness and skin irritation. A 148-patient trial found that 84% preferred the new product over Covidien's older Kendall SCD Express sleeve.