Actegy - Aerosure respiratory muscle training mask

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Actegy Pty Ltd

I, Leanne McCauley, Delegate of the Secretary to the Department of Health, on receipt of an application from Actegy Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraphs (a) and (b) below for use in advertisements directed to consumers, for the product identified in paragraph (c), provided the conditions identified in paragraph (d) are met:

1. Do not use if you:
   • Have epilepsy
   • Are coughing up blood (active haemoptysis)
   • Have acute sinusitis or an active nosebleed
   • Have recently had thoracic (chest) or upper gastro-intestinal tract (duodenum, stomach, oesophagus) surgery or trauma until completely healed
   • Currently have or previously had a collapse lung (Pneumothorax)
   • Have abnormally high or low blood pressure, very slow or very fast heart rate (haemodynamic instability) including severe right-sided heart failure with hypotension
   • Currently have a blood clot in the blood vessels in the lungs (Pulmonary Embolism)
   • Have enlarged veins in the walls of the oesophagus (oesophageal varices)
   • Have abnormally high pressure in the skull and brain (raised intracranial pressure)
   • You are experiencing a sudden worsening of breathlessness. For example (but not limited to) exacerbations of asthma
2. Representations to the effect that
   1. use of the Device may reduce breathlessness in people with chronic obstructive pulmonary disease (COPD); and
   2. the use of the Device may produce beneficial effects in terms of increased respiratory fitness in people with chronic obstructive pulmonary disease (COPD)
3. Aerosure respiratory muscle training mask (ARTG No. 207099)
4.  
   • the use of either representation (b)(i) or (b)(ii). must be accompanied by the contraindications set out in paragraph (a) above;
   • representation (b)(i) must be used in conjunction with representation (b)(ii);
   • where both representations are used in an advertisement, they must be equally prominent; and
   • the use of either representation (b)(i) or (b)(ii) must be accompanied by a statement to the following effect:
     • Aerosure may not be suitable for all people with COPD. Its use should not replace your pulmonary rehabilitation program. If you have COPD you should discuss the suitability of Aerosure with your healthcare professional to ensure it is right for you.

Dated this 13th day of December 2017

Leanne McCauley
Delegate of the Secretary to the Department of Health
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch