Covidien has obtained 510(k) clearance from the FDA for its new Kendall SCD Compression Comfort Sleeve and Kendall SCD 700 Series Controller. The compression system is used on legs of patients as a prevention for DVTs and PEs.
The system utilizes the clinically proven Kendall SCD technology, which delivers sequential, gradient, circumferential compression to reduce the incidence of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) without the bleeding risk associated with anticoagulant prophylaxis.
The system incorporates a number of physician and patient-focused enhancements. With its unique DCS Technology, the Comfort Sleeve addresses the factors contributing to patient discomfort, including sweat, heat, itchiness, pressure and skin irritation. The all-in-one controller improves functionality and convenience with a new graphical user interface with animated icons, allowing for a more intuitive operation.
In a multicenter, prospective clinical study involving 148 hospitalized patients, the Kendall SCD Comfort Sleeve was preferred by 84% of participants over the Kendall SCD Express Sleeve. In addition, the Comfort Sleeve was also identified as being less sweaty, cooler in temperature and more flexible for patients.