Healthcare Industry News:  ventilator 

Devices FDA

 News Release - March 3, 2008

Draeger's SmartCare(R)/PS Reduces Overall Ventilation Time 33%, Weaning Time up to 40% and ICU Length of Stay to 20%

Automated Weaning Option for the EvitaXL ventilator Receives FDA Clearance for Additional Claims Based on Multi-Center Randomized Trial (1)

TELFORD, Pa.--(HSMN NewsFeed)--Draeger Medical, Inc. today announced its SmartCare/PS option for the EvitaXL ventilator and has received market clearance for additional product claims from the U.S. Food and Drug Administration (FDA). Introduced in November 2005, SmartCare is a knowledge-based ventilation system developed to improve the efficiency and effectiveness of the weaning process for hemodynamically and neurologically stable patients without severe Chronic Obstructive Pulmonary Disease (COPD). SmartCare can help reduce patient intensive care days as well as ventilator days by integrating protocolized care into automated ventilation weaning. The newly cleared claims for SmartCare address clinical and efficiency benefits in ventilator therapy, including –

Time reduction:
  • Reduce overall ventilation time by 33%[2]
  • Decrease ICU length of stay by up to 20%[2]
  • Reduce weaning duration by up to 40%[2]
By reducing weaning time and potential associated complications and infections, SmartCare may lead to reductions in the cost of care, improved resource utilization, and decreased incidence of ventilator morbidity. This includes potential medical results such as:
  • Increased efficiency and improved therapy
  • Reduced ventilator-induced injuries and complications
  • Decreased potential for infections
  • Decreased re-intubation
  • Increased quality of outcomes
  • 100% weaning protocol compliance
SmartCare automates the weaning process, based on the user’s input, using continuously measured parameters and patient respiratory profiles. As the level of ventilator support is adjusted automatically, the patient’s response and ability to adapt to each change in support is evaluated.

Traditional methods of weaning vary greatly, do not always progress with the patient’s ability to wean, and are labor-intensive for hospital staff. Unlike these intermittent processes, SmartCare continuously monitors the patient, interprets the data, and adjusts the level of ventilator in two- or five-minute intervals.

“Literature [3] suggests that a significant amount of clinicians’ time is spent in attempts to wean patients off ventilator support,“ said Ed Coombs, RRT, Critical Care and Ventilation, Draeger Medical, Inc. “SmartCare is a reengineering of the weaning process through automation of accepted clinical protocols. It is a tool that extends the clinician’s ability to make necessary adjustments required to progress care of the weaning patient. By simply observing, adapting and maintaining the patient, SmartCare provides the potential to improve outcome while decreasing cost.”

About Draeger

Draegerwerk AG & Co. KGaA is an international leader in the fields of medical and safety technology. Draeger products protect, support and save human life. Founded in 1889, in 2006 the Group achieved sales of €1,801.3 million worldwide and an EBIT of €148.2 million. Today, Draeger employs around 10,000 people in more than 70 subsidiaries worldwide and has representation around 190 countries. The Draeger Medical subsidiary offers products, services and integrated system solutions which accompany the patient throughout the care process – Emergency Care, Perioperative Care, Critical Care or Perinatal Care and Home Mechanical Ventilation. For more information, visit www.draeger.com.

[1] Lellouche F. et al., A Multicenter Randomized Trial of Computer-driven Protocolized Weaning from Mechanical Ventilation. American Journal of Respiratory Critical Care Med, Vol. 174. pp 894–900, 2006.

[2] These results are based on a European Multi-center Randomized Trial with 144 patients demonstrating improved respiratory condition, with stable hemodynamic and neurologic status, and no ARDS prior to initiating weaning.

[3] Esteban A, Alia I, Ibanez j, et al. Modes of mechanical ventilation and weaning. Chest 1994; 106:1188-1193.


Source: Draeger Medical

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