November 8, 2023: Otsuka Medical Devices Co., announced its treatment for hypertension has got approval from the US Food and Drug Administration.
The ‘Paradise system’ is an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure.
Hypertension is the leading cause of cardiovascular disease and premature death worldwide. Estimates suggest that in 2010, 31.1% of adults or 1.39 billion people worldwide had hypertension, according to the National Institutes of Health.
Owing to the widespread use of antihypertensive medications, global mean blood pressure has remained constant or decreased slightly over the past four decades.
Variations in the levels of risk factors for hypertension, such as high sodium intake, low potassium intake, obesity, alcohol consumption, physical inactivity and unhealthy diet, may explain some of the regional heterogeneity in hypertension prevalence.
Otsuka’s system is based on ultrasound renal denervation (RDN) technology designed to lower blood pressure by “denervating the sympathetic nerves surrounding the renal arteries,” reducing the overactivity that can lead to hypertension, according to the company statement.
The system delivers three doses of 360-degree ultrasound energy — lasting seven seconds each — through each of the main renal arteries to the surrounding nerves.
It circulates sterile water through a balloon catheter during the procedure to help protect the renal artery wall.
Studies were done on more than 500 patients with uncontrolled hypertension. “Each trial met its prescribed primary efficacy endpoint with a favourable safety profile consistently observed following ultrasound RDN treatment.”
The treatment previously received “Conformité Européenne”, the French for European conformity, mark and has been successfully introduced in Europe and is an investigational device in Japan.
Otsuka is headquartered in Tokyo and was established in 1964.