Friday November 22, 2019

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

Mutations in Genes Associated with Heart Disease: Study

The study was presented at the 2019 American Heart Association Scientific Sessions in Philadelphia, US

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Genes
Apart from Genes, Researchers also identified lifestyle, environmental and other disease factors documented in the medical records that are associated with heart problems, like high blood pressure, diabetes, a history of alcohol or drug abuse, or previous chemotherapy treatment. Pixabay

Researchers have identified new mutations in Genes that is commonly associated with non-ischemic dilated cardiomyopathy (NIDC), a disease that weakens the heart muscle, making it more difficult to adequately circulate blood to meet the body’s needs.

Patients with NIDC struggle because the heart’s ability to pump blood is decreased, as the heart’s main pumping chamber, the left ventricle, is enlarged and dilated.

Unlike other kinds of heart conditions, NIDC often isn’t related to or a symptom or sign of a known cardiovascular disease or disease risk factor.

In the study, researchers from the Intermountain Healthcare Heart Institute in the US, have identified 22 mutations in 27 of 229 NIDC patients in a gene called TITIN — 15 of them not previously discovered.

These TITIN mutations are of a type called “truncating variants”, or TTN-tv, which are linked with the development of cardiomyopathy and heart failure.

“Truncating mutations in TITIN are common in NIDC, so we wanted to know: if we find one, should we be more, or less worried about the patient’s prognosis? The answer is yes,” said principal investigator of the study Jeffrey L. Anderson.

In the study, the DNA samples of the 229 Intermountain patients diagnosed with NIDC were analysed.

Researchers also identified lifestyle, environmental and other disease factors documented in the medical records that are associated with heart problems, like high blood pressure, diabetes, a history of alcohol or drug abuse, or previous chemotherapy treatment.

Patients were evaluated when they first presented and then were followed for five years.

Genes
Researchers have identified new mutations in Genes that is commonly associated with non-ischemic dilated cardiomyopathy (NIDC), a disease that weakens the heart muscle, making it more difficult to adequately circulate blood to meet the body’s needs. Pixabay

Patients with a TTN-tv mutation more often had severe cardiomyopathy at presentation, and by five years they were less likely to have recovered (11 per cent of those with a mutation versus 30 per cent of those without).

These patients also were more likely to have shown progressive disease, such as a heart transplant, implant of a permanent heart assist device, or death if they had a TTN-tv mutation (41 per cent) than if they didn’t (25 per cent).

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TTN-tv mutation patients also commonly were found to have non-genetic predisposing factors, suggesting that these other factors may act in concert with genetic factors to precipitate heart failure.

The study was presented at the 2019 American Heart Association Scientific Sessions in Philadelphia, US. (IANS)