With the use of a catheter, Medtronic’s renal denervation device reduces blood pressure by using radiofrequency radiation to quiet hyperactive nerves close to the kidneys.
In November, the FDA approved Symplicity Spyral, a product of the company. More than ten years ago, the company was granted permission to market a renal denervation device in Europe, but, until 2023, rules categorized the method as an exploratory treatment. In 2023, the European Society of Cardiology reversed course and suggested renal denervation for patients with medication-resistant hypertension.
Following its market openings in the United States and Europe last year, Medtronic has now obtained approval in China. It mentioned the data in its announcement. Over 270 million people worldwide suffer from hypertension, according to the World Health Organization, of which only 14% have it under control. Some individuals also lack access to therapy.
Medtronic anticipates modest sales in the near future. The first stage in getting a device to patients in China is NMPA approval. The company intends to proceed with the provincial registration procedure at this time.
Rivals have expressed interest in China, but Medtronic claims to be the first business to go through that process with a renal denervation device. In 2016, Recor Medical—a rival of Medtronic in the United States—sold Otsuka Holdings the rights to use its renal denervation technology for commercial purposes in Asia. Recor was purchased by Otsuka after two years.
Renal denervation devices are also being developed by Chinese medtech businesses. Shanghai Golden Leaf Medtec and Symap Medical released clinical research results on their respective technologies in 2023.
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