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Challenging Hypertension Through Novel Medical Device Development

Periodic Reporting for period 1 - REALTA (Challenging Hypertension Through Novel Medical Device Development)

Reporting period: 2017-07-01 to 2018-12-31

High blood pressure, also known as hypertension, is a global health problem that accounts for more than 9.4 million deaths every year, and affects over 1 billion people worldwide. Hypertension directly causes approximately 25% of heart attacks in Europe and, in its progressed form of cardiovascular disease, is responsible for 42% of all deaths across Europe annually. It is one of the primary contributors to many of the medical conditions with the greatest burden of care in Europe, including stroke, dementia and kidney failure.

The EU’s main health policy document, Health 2020, has made tackling hypertension a clear priority, in an effort to address one of Europe’s major contributors of disease. In the last ten years, Primary Aldosteronism (PA, also known as Conn’s Syndrome) has been recognised as the most common curable cause of hypertension. PA is thought to account for up to 18% of all cases of hypertension within the population and is caused by benign shallow hormone-eluding adenomas on the surface of the adrenal gland. Researchers have identified the effective treatment of PA as a clear mechanism to address a significant portion of Europe’s hypertension problem.

However, finding a suitable surgical or pharmaceutical treatment for PA has been challenging to date. The most commonly performed treatment for PA is an adrenalectomy, the unilateral removal of the complete adrenal gland3,5,6. Studies have shown that PA can be cured by removing the adrenal gland6, with biochemical levels and blood pressure returning to normal and the reversal of organ damage caused by the disease5. Disappointingly however, PA often reoccurs in the remaining contralateral adrenal gland. In such cases, the disease is managed with pharmaceuticals; however this approach is poorly tolerated by patients due to very significant side-effects6. These challenges provide a clear motivation for a safer, less invasive and more effective treatment for PA and associated hypertension.

Based on new studies of the dielectric properties of adrenal tissue, and two prototypes developed during the ERC BioElecPro project, the REALTA project has developed a novel microwave ablation system that is capable of identifying and destroying shallow adrenal adenomas to combat PA, critically whilst preserving the functional tissue of the remaining adrenal gland.

Within the project, a novel platform device was created. The device is safe and effective, and was fully tested in a carefully designed animal study. The team have recently met with both investors and industry (under non-disclosure agreements) and have identified a clear path to market. The team are now raising funds to commercialise the technology, and are confident that with funding their device can ultimately have a real and tangible impact on patient care.