I, Michael Shum, as a delegate of the Secretary to the Department of Health and Aged Care, on receipt of an application from Boston Scientific Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the use of the restricted representations in paragraph (A), in advertisements for the products identified in paragraph (B) when the statements identified in paragraph (C) are prominently displayed or communicated[1] in such advertisements.
(A)
- Representations to the effect that the Boston Scientific Rezum Water Vapor Therapy System is indicated to relieve symptoms, obstructions, and reduce prostate tissue associated with Benign Prostatic Hyperplasia (BPH). Other common terms associated with Benign Prostatic Hyperplasia include Benign Prostatic/Prostate Enlargement (BPE), Benign Prostatic/Prostate Obstruction (BPO) and enlarged prostate.
(B)
- Electrosurgical System Generator - Electrosurgical system generator, general-purpose (ARTG 329140)
- Delivery Device - Radio-frequency probe cannula (ARTG 329141)
(C)
- Surgery is required to use the Rezum System, and any surgical procedure carries risk.
- Outcomes may vary for each patient.
- Consult with your doctor to determine if the Rezum System is suitable for you and any factors that could impact your response.
Dated 8 August 2024
Signed electronically
Michael Shum
Delegate of the Secretary to the Department of Health and Aged Care
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch
[1] As defined in the applicable version of the Therapeutic Goods Advertising Code, as amended from time to time.