Sunday January 26, 2020

FDA Approves Device to Treat Heart Failure Patients

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics

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The US Food and Drug Administration has given approval for a new device that would help treat patients with life-threatening heart failure, and address an unmet need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

The Optimizer Smart system is comprised of several components, including an implantable pulse generator, battery charger, programmer and software. The pulse generator is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart.

After the device is implanted, a physician tests and programmes the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s squeezing capability.

The device would be beneficial for patients not suited to treatment with other heart failure devices such as cardiac resynchronisation therapy to restore a normal timing pattern of the heartbeat, the US FDA noted in a statement.

“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” said Bram Zuckerman, Director at FDA’s Centre for Devices and Radiological Health.

Photo Credit: www.medscape.com

“The FDA recognised the unmet need for these patients and worked with the manufacturer…to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Zuckerman added.

For the study, the US FDA evaluated data from two clinical trials with a total of 389 patients with moderate-to-severe heart failure.

All patients received optimal medical therapy and 191 patients also received an Optimizer Smart system implant.

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The Optimizer Smart system improves quality of life and functional status of certain heart failure patients.

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics. (IANS)

Next Story

Diabetes is an Independent Risk Factor For Heart Failure: Study

According to health expert in India, if poorly controlled, diabetes leads to cardiomyopathy resulting in progressive deterioration of pumping capacity of heart

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Diabetes
The study shows that diabetes is an independent risk factor for the development of heart failure in the community dwelling population. Pixabay

Heart problems are a common development for people with diabetes and now researchers have found that diabetes is an independent risk factor for the development of heart failure in the community dwelling population.

According to health expert in India, if poorly controlled, diabetes leads to cardiomyopathy resulting in progressive deterioration of pumping capacity of heart.

“Diabetes is also a major risk factor for atherosclerosis and this eventually leads to blockage of coronary arteries. This leads to heart attack or myocardial infarction,” Satish Koul, HOD and Director Internal Medicine, Narayana Superspeciality Hospital, Gurugram, told IANS. “Due to myocardial infarction, the heart muscle becomes weak and eventually heart fails as a pump leading to congestive heart failure,” Koul added.

According to the current study, published in the journal Mayo Clinic Proceedings, researchers evaluated the long-term impact of diabetes on the development of heart failure, both with preserved ejection fraction – a measurement of the percentage of blood leaving the heart with each contraction – and reduced ejection fraction. They also looked at mortality in a community population, controlling for hypertension, coronary artery disease and diastolic function.

From an initial group of 2,042 residents of Olmsted County in US, 116 study participants with diabetes were matched 1:2 for age, hypertension, sex, coronary artery disease and diastolic dysfunction to 232 participants without diabetes.

Over the 10-year follow-up period, 21 per cent of participants with diabetes developed heart failure, independent of other causes.

Diabetes
Heart problems are a common development for people with diabetes and now researchers have found that diabetes is an independent risk factor for the development of heart failure in the community dwelling population. Pixabay

In comparison, only 12 per cent of patients without diabetes developed heart failure. Cardiac death, heart attack and stroke were not statistically different in the study between the two groups.

The study shows that diabetes is an independent risk factor for the development of heart failure in the community dwelling population. Furthermore, the outcome data support the concept of a diabetic cardiomyopathy.

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This research extends previous findings and demonstrates that even without a known cardiac structural abnormality and with a normal ejection fraction, diabetic patients are still at increased risk of developing heart failure as compared to their nondiabetic counterparts. (IANS)