BOULDER, Colo., Sep 30, 2009 (BUSINESS WIRE) -- 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(TM)
TaperGuard(TM) Evac endotracheal tube. The TaperGuard endotracheal tube
reduces leakage past the cuff by at least 81%, compared with the
Mallinckrodt Hi-Lo(TM) 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
"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."
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 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.
Sherri Hughes-Smith, 303-581-6849
Manager, Media and Public Relations
Respiratory and Monitoring Solutions
Bruce Farmer, 508-452-4372
Coleman Lannum, CFA, 508-452-4343
Brian Nameth, 508-452-4363