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|Covidien Receives FDA 510(k) Clearance for Kendall SCD(TM) Compression Comfort Sleeve and Kendall SCD(TM) 700 Series Controller|
MANSFIELD, Mass., Nov 04, 2010 (BUSINESS WIRE) -- Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in intermittent pneumatic compression (IPC), today announced 510(k) clearance from the U.S. Food and Drug Administration for the Kendall SCD(TM) Sequential Compression Comfort Sleeve and Kendall SCD(TM) 700 Series Controller. The new system will be launched next month in the U.S. and will deliver an improved level of comfort for patients, while reducing the risk of venous thromboembolism (VTE).
The Kendall SCD Comfort Sleeve and Kendall SCD 700 Series Controller provide improved patient comfort for increased compliance, as well as ease of operation for the clinician. 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) 12 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.
"The Kendall SCD Sleeve and Kendall SCD 700 Series Controller will provide physicians and healthcare professionals with a clinically proven and noninvasive solution that can improve patient outcomes in the prevention of VTE," said Joe Woody, President, Vascular Therapies, Covidien. "The new system further exemplifies Covidien's commitment to innovation in the IPC market, by providing a comfortable and convenient product."
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.3
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2009 revenue of $10.3 billion, Covidien has 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.
1 Nicolaides, et al., Intermittent Sequential Pneumatic Compression of the Legs in the Prevention of Venous Stasis and Postoperative Deep Vein Thrombosis, Surgery, Jan 1980, 69-76.
2 Ramos, et al., The Efficacy of Pneumatic Compression Stockings in the Prevention of Pulmonary Embolism After Cardiac Surgery, CHEST, Vol. 109, Jan 1996, 82-85.
3 Conway D. et al. A Controlled Study Evaluating a Newly Designed Sequential Compression Comfort Sleeve in Hospitalized Patients. Poster presentation at the Academy of Medical Surgical Nurses (AMSN), October 2010.