Renin-based high blood pressure test gets FDA clearance to enter U.S. market.
Immunodiagnostic Systems (IDS) has received USA Food and Drug Administration (FDA) clearance for its Direct Renin assay ― a procedure to measure blood pressure, on the company’s automated analyzer IDS-iSYS system.
The IDS-iSYS Direct Renin immunoassay is used to determine the amount of active renin enzyme that is present in the blood. Renin regulates the body’s blood pressure and can cause high blood pressure. The system was already launched in Europe in June 2012 and the FDA clearance now allows the Company to market the assay in the United States.
Results of the test are used in conjunction with other clinical and laboratory data to assist clinicians in the investigation of hypertension related disorders such as primary aldosteronism and renovascular hypertension. The test enables the quantitative determination of renin in less than an hour, providing laboratories with a fast and reliable alternative to existing laborious manual methods, a necessity when screening in extended hypertensive populations.
According to the WHO, hypertension affects 20 percent of the population. Worldwide, hypertension is the third leading cause of death after malnutrition and diseases related to smoking. According to the Centers for Disease Control and Prevention 67 million American adults (31 percent) have high blood pressure, one in every three American adults.
Patrik Dahlen, IDS CEO, commented, “We are delighted to receive the clearance of our automated Direct Renin immunoassay allowing us to enter the US market with this important diagnostic test. We remain focused on increasing the assay menu available to customers on the IDS-iSYS automated system.”
People diagnosed with hypertension after being tested, need to consider all options to overcome their condition. Besides frequent blood pressure checks, exercise, and healthy, balanced and regular eating habits, there are all-natural and effective treatments. RESPeRATE is the first medical device clinically proven to lower blood pressure. By interactively guiding the user through unique breathing exercises that relax constricted blood vessels, blood pressure levels are reduced. RESPeRATE is also a treatment for stress, which in itself can lead to high blood pressure.