United Kingdom: The Rubidium (Rb82) Generator (RUBY-FILL) has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA), as a diagnostic tool for people with heart diseases.
This tool helps evaluate blood flow and assists in the diagnosis or assessment of suspected or known coronary heart disease. Every year, 68,000 British citizens die from coronary heart disease (CHD), which is the leading cause of death worldwide.
CHD occurs when fatty sediments build up in the coronary arteries and thwart the blood supply to the heart. In some cases, it can cause a heart attack. In the United Kingdom, 2.3 million people suffer from this disease, making it the most ordinary heart and circulatory disorder.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, stated that, “Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us. We’re assured that the appropriate regulatory standards for the approval of this diagnostic have been met. As with all products, we will keep its safety under close review.”
Under the supervision of a specialist doctor, the Rubidium (Rb82) Generator involves one or two injections at least 10 minutes apart. The scans take place every 5 minutes.
This substance, known as a radiopharmaceutical, contains small amounts of radioactivity. It accumulates temporarily in specific parts of the body and can be noticed by special cameras outside the body. A healthcare expert can seize an image that delivers valuable facts about blood flow to the heart.
This radiopharmaceutical produces low doses of ionising radiation, which is linked to a very minimal risk of cancer and passing on faulty genes. The physician will consider the clinical benefit of the procedure with the radiopharmaceutical to be more significant than the risk from the radiation.