Covidien (NYSE: COV), a leading global healthcare products company and recognized innovator in mechanical ventilation and respiratory care devices, today announced the global launch of Mallinckrodt™ TaperGuard™ and TaperGuard™ Evac endotracheal tubes. The TaperGuard line of endotracheal tubes incorporates a unique, taper-shaped cuff made from polyvinylchloride (PVC) that is designed to substantially reduce the risk of microaspiration. The TaperGuard Evac endotracheal tube additionally provides for secretion drainage through an integrated suction lumen. As a result, the TaperGuard Evac endotracheal tube is associated with a reduction in ventilator-associated pneumonia (VAP). ¹

Microaspiration refers to the entry of foreign material into the respiratory tract. The TaperGuard line of endotracheal tubes offers a superior cuff seal, compared with conventional endotracheal tubes, to help block secretions from entering the airways. Specifically, the innovative taper-shaped cuff design substantially reduces microaspiration by an average of 90%, versus the conventional barrel-shaped PVC cuff, found on the most widely used endotracheal tube -- the Mallinckrodt™ Hi-Lo™ endotracheal tube.²

“In the 1970’s, we introduced the Hi-Lo endotracheal tube, which has been the standard of care for many years,” said James E. Willett, Vice President and General Manager, Airway Management and Ventilation, Covidien. “Today, the innovative taper-shaped cuff of the TaperGuard endotracheal tube offers enhanced protection for all intubated patients. The TaperGuard device is the next-generation endotracheal tube, one that reflects our commitment to developing products that improve patient safety by reducing microaspiration, which is associated with a variety of pulmonary complications, including pneumonia.”

Medical literature over the past four decades suggests that post-intubation pulmonary complications are prevalent, costly and associated with increased morbidity and mortality. The four most commonly cited pulmonary complications are pneumonia, respiratory failure, atelectasis and acute exacerbation of chronic lung disease.³ Each of these complications has been associated with microaspiration of secretions into the lungs. Studies have reported volumes of up to 150 ml of secretions being removed per day above the cuff.⁴ Additional data suggests that, with conventional endotracheal tubes, microaspiration can occur at any time from intubation to extubation.

“Microaspiration is always a possibility during an operation and may lead to post-intubation pulmonary complications, such as pneumonia,” said Douglas Hansell, M.D., M.P.H., Chief Medical Officer & Vice President, Respiratory and Monitoring Solutions, Covidien. “The advanced design of the TaperGuard endotracheal tube has the potential to significantly minimize many of the risks associated with post-intubation pulmonary complications.”

The TaperGuard Evac endotracheal tube combines the TaperGuard cuff with Mallinckrodt Evac technology, which offers secretion management capabilities by enabling continuous or intermittent drainage of secretions that collect above the cuff.

“The global launch of the TaperGuard line of endotracheal tubes illustrates Covidien’s commitment to developing innovative, proven solutions for commonly occurring healthcare complications, with the goal of decreasing patient mortality, as well as healthcare costs,” said Pete Wehrly, President, Respiratory and Monitoring Solutions, Covidien. “With each new product and technology, our goal remains the same: to enhance patient safety, medical efficacy and healthcare efficiency,” he added.

About Covidien

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 2008 revenue of $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

¹ 510 (k) clearance letter.

² 510 (k) clearance letter.

³ Arozullah et al. Ann Surg. 2000;232(2):242-253.

⁴ Rawlinson, E. Pulmonary aspiration. Anesthesia and Intensive Care Medicine. 2007: 8(9); 365-367.