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Abbott Receives U.S. FDA Approval for RX Herculink Elite® Renal Stent System ...
/PRNewswire/ -- Abbott (NYSE: ABT ) today announced it has received U.S. Food and Drug Administration (FDA) approval for the RX Herculink Elite® Renal Stent System for the treatment of renal artery stenosis (narrowing of the main arteries supplying blood to the kidneys) in patients with uncontrolled hypertension (high blood pressure). Over time, narrowed kidney arteries can lead to kidney failure and increased risk of heart disease, stroke and peripheral artery disease. This approval is supported by the HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety) study, which demonstrated that RX Herculink Elite is safe and effective in patients with renal artery stenosis and uncontrolled hypertension."One striking result of the HERCULES study was the reduction in blood pressure we saw with RX Herculink Elite in patients with uncontrolled hypertension – those who are not adequately managed with multiple blood pressure medications," said . The cobalt chromium alloy allows for thin stent struts, providing increased flexibility while maintaining strength to support the vessel and visibility during a stent implantation procedure for accurate placement.
HERCULES is a prospective study designed to evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in patients with atherosclerotic renal artery stenosis with uncontrolled hypertension. The study, which enrolled 202 patients at 37 study sites in the U.S., met its primary endpoint, with a significantly low restenosis (vessel re-narrowing) rate of 10.5 percent at nine months post-treatment (p<0.0001). Very low safety event rates were seen, with 99.0 percent of patients experiencing no kidney-related safety complications within 30 days after treatment. A reduction in systolic blood pressure was seen in approximately 78 percent of patients at nine months, with the greatest reduction seen in patients who had the highest blood pressure levels at the start of the study (94 percent of patients with baseline systolic blood pressure > 180 mmHg experienced an average decrease of 48 mmHg).
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Elevated blood pressure makes the heart work harder and, over time, can cause heart failure and damage blood vessels throughout the body, including vessels to the brain and the eye. When the vessels in the kidneys are damaged, kidney function decreases
Sleep apnea can eventually lead to hypertension (high blood pressure), more accidents because the patient is sleepy during the day, diabetes, and heart disease. The CPAP is commonly prescribed by doctors for obstructive sleep apnea treatment.
Patients treated with antipsychotic medication, especially those with schizophrenia, have a high rate of metabolic problems, for example up to 60% have lipid abnormalities, 40% have high blood pressure, and 30% suffer from the metabolic syndrome.
In addition to the software that specifically supports the requirements of blood glucose meters, Lamprey Networks offers software for other types of medical devices, such as blood pressure monitors. Product developers can leverage this software to
One of the blood-pressure drugs, called an ACE inhibitor, relaxes blood vessels by preventing the body from creating a particular hormone. The other drug, called an ARB, acts on the same hormonal system but in a different way. High blood pressure can
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Blood Pressure Devices:Blood Pressure Monitor,Omron,Braun & Mabis
The term blood pressure devices covers a wide range of medical products for use in measuring and treating the condition known as hypertension or high blood pressure. ...
Rheos Clinical Study for High Blood Pressure
CVRx is clinically evaluating an alternative treatment to lower high blood pressure, called Rheos High Blood Pressure or Hypertension Therapy System.
RESPeRATE Device May Lower Blood Pressure
The computerized musical device called RESPeRATE helps people breathe slowly and lowers their blood pressure, research shows.
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Checking your blood pressure at home is an important part of managing high blood pressure (hypertension) ... Devices that measure your blood pressure at your finger are not ...
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