EU Launch for Smiths Medical Tracheostomy Tubes for Neonates and Pediatric Patients

Smiths Medical says that its Portex® Bivona® FlexTend™ TTS™ tracheostomy tubes will now be included in the company’s standard product offering for European countries. The Bivona® FlexTend™ TTS™ neonatal and pediatric tubes feature a proximal shaft extension helping to keep connections away from the neck, chin, and stoma, intended to enhance patient comfort which could prevent pressure ulcers.

Background

Bivona® FlexTend™ TTS™ tracheostomy tubes, made of soft, natural, biocompatible silicone, are intended to be gentle on the sensitive tissues of neonatal and pediatric patients who require intermittent or temporary cuff use. An inflatable cuff integrated into the outer wall of the tube’s shaft can be filled with sterile water to secure the tube in the patient’s trachea and create a seal between the tube and trachea that directs incoming and outgoing breaths through the inner lumen. This helps to optimize respiration for ventilated patients and for patients who perform lung expanding breathing therapies. When a seal is no longer needed, the cuff can be deflated and it will rest tight-to-shaft (TTS), reducing the risk of trauma to the trachea and allowing airflow around the tube supporting the ability to speak.

Smiths Medical says the new standard Bivona® FlexTend™ TTS™ tracheostomy tubes are manufactured in volume and stocked to fill orders promptly and to enable customers to keep inventory on hand for eventual needs. The company will also continue to provide Bivona® FlexTend™ TTS™ tracheostomy tubes through its customization service. Customized tubes are assembled to follow the unique contours and dimensions of a patient’s neck and trachea, and are essential to patients who have unique needs or an atypical tracheal anatomy.

Company comments 

“We are pleased to add what was originally a customized specialty device to our standard Bivona® tracheostomy product portfolio in Europe,” said Tommy Johns, Vice President Global Product Management. “This will ensure greater accessibility to the Bivona® FlexTend™ TTS™ tracheostomy tubes and provides patients and health care providers with exactly what they need, precisely when they need it.”

Regulatory status

Bivona® FlexTend™ TTS™ tracheostomy tubes are now available in the US and the European Union and will be available in other regions later this year.

Source: Smiths Medical, Business Wire

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