Covidien Receives FDA Clearance For Its Mallinckrodt™ TaperGuard™ Evac Endotracheal Tube

Main Category: Respiratory / Asthma
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 02 Oct 2009 - 0:00 PDT

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Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in mechanical ventilation and respiratory care devices, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Mallinckrodt™ TaperGuard™ Evac endotracheal tube. The TaperGuard endotracheal tube reduces leakage past the cuff by at least 81%, compared with the Mallinckrodt Hi-Lo™ endotracheal tube1, potentially reducing the risk of postsurgical complications that may be caused by aspiration of fluids into the lungs.

Although complications from pulmonary aspiration are rare, the consequences can be severe.2 Overall, the incidence of aspiration in adults is 1 in 3,000 anesthetics3, with a mortality rate of between 8% and 10%.4 High-volume, low-pressure (HVLP) cuffs were developed in the 1970s to reduce the risk of aspiration; however, fluid leakage past the cuff with conventional HVLP cuffs remains prevalent and is well-documented.5,6,7 Recent market research demonstrates limited clinical knowledge among physicians about the sealing performance of traditional HVLP endotracheal tube cuffs.8

"The FDA 510(k) clearance of the TaperGuard line of endotracheal tubes provides Covidien with an opportunity to further educate physicians about the risks and consequences associated with intraoperative leakage of secretions past inflated endotracheal tube cuffs," said Roger Mecca, M.D., Vice President, Medical Affairs, Respiratory and Monitoring Solutions, Covidien. "The possibility of postoperative complications related to unobserved aspiration past the cuff during general anesthesia is likely unappreciated, so enhancing awareness of this potential issue is timely."

"The TaperGuard endotracheal tubes offer significant advantages for anesthesiologists, surgeons and their patients," said Jim Willett, General Manager and Vice President, Airway and Ventilation, Covidien. "This FDA 510(k) clearance means more physicians will gain awareness of this innovative product and incorporate its use into their procedures, confirming Covidien's mission to provide solutions designed to improve patient safety, medical efficacy and healthcare efficiency."

1. 510 (k) clearance letter.

2. Nagelhout, et al. Aspiration prophylaxis: Is it time for changes in our practice? AANA Journal. 2003; l71(4).

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

4. Benington, et al. Pulmonary aspiration. Anesthesia and Intensive Care Medicine. 2007; 8(9): 368.

5. Oikkonen M, Aromaa U. Leakage of fluid around low-pressure tracheal tube cuffs. Anaesthesia. 1997; 52: 567-569.

6. Young JP. Leakage of fluid past the tracheal tube cuff in a bench top model. British Journal of Anaesthesia. 1997; 78:557-562.

7. Lucangelo U, et al. Effect of positive expiratory pressure and type of tracheal cuff on the incidence of aspiration in mechanically ventilated patients in an intensive care unit. Critical Care Medicine. 2008; 36(1): 1-5.

8. Internal document. Market research performed by a 3rd party vendor. Conjoint Analysis.

Source
Covidien

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