Sunday April 21, 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

Smart Toilet Seats can Monitor Patients with Congestive Heart Failure

The toilet seats are equipped to measure the electrical and mechanical activity of the heart, and can monitor heart rate, blood pressure, blood oxygenation levels

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The toilet seats would be purchased by hospitals and issued to heart failure patients after discharge, it added. Pixabay

Hospitals will soon be able to monitor patients with congestive heart failure in the comfort of their own homes, thanks to a new type of toilet-seats that can measure biometrics during “natural” processes.

The toilet seats are equipped to measure the electrical and mechanical activity of the heart, and can monitor heart rate, blood pressure, blood oxygenation levels, and the patient’s weight and stroke volume, which is the amount of blood pumped out of the heart at every beat.

Created by a team of researchers from the Rochester Institute of Technology in New York, the toilet seats will be brought through the US Food and Drug Administration (FDA) clearance process by the researchers’ company Heart Health Intelligence, the institute said in a statement on Wednesday.

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Algorithms in the seats will analyse the data, and with further development warn of deteriorating condition. Pixabay

The toilet seats would be purchased by hospitals and issued to heart failure patients after discharge, it added.

ALSO READ: Chinese Scientists Develop Robotic System for Medical Use

Algorithms in the seats will analyse the data, and with further development warn of deteriorating condition.

The system will pick up deteriorating conditions before the patients even realise they are symptomatic, said Nicholas Conn, a postdoctoral fellow at RIT and founder and CEO of Heart Health Intelligence. (IANS)