Treating Morbid Extreme Obesity.
A first-of-its-kind ingraft that curbs the enthusiasm by electrically stimulating stomach nerves was approved Wednesday by the US Food and Drug Administration. The Maestro Rechargeable System is intended to review morbid (extreme) obesity, legend manufacturer EnteroMedics Inc said in its application for FDA approval. The implant sends electrical signals to nerves around the abide that help control digestion scriptovore com. These signals deterrent the nerves, decreasing hunger pangs and making the person feel full.
The FDA approved the cognizance for use in people 18 and older who have a body-mass index (BMI) of 35 to 45 and at least one other obesity-related condition, such as breed 2 diabetes. BMI is a ratio that determines body fat based on a person's pinnacle and weight. For example, a person who's 5 feet, 8 inches preposterous and weighs 230 pounds has a BMI of 35 formula. People with a BMI of 30 or higher are considered obese, according to the US Centers for Disease Control and Prevention.
People receiving a Maestro teach also must have tried and failed to squander weight with a traditional weight loss program, the FDA said. The machinery is the first FDA-approved obesity device since 2007. In clinical trials, clan with a Maestro implant lost an average 8,5 percent more weight after one year than others who received a pretender implant. About half of the implanted patients lost at least 20 percent of their redundancy weight, and 38 percent lost at least 25 percent of their excessive weight.
EnteroMedics reported that people with fake implants regained about 40 percent of the pressure they had lost within six months of the trial's end, while the people with the Maestro device appeared to persist in their weight loss. According to the CDC, more than one-third of all US adults are obese, and people with embonpoint are at increased risk of heart disease, stroke, type 2 diabetes and certain cancers.
And "Obesity and its kindred medical conditions are major public health problems," Dr William Maisel, head scientist in the FDA's Center for Devices and Radiological Health, said in an force news release. "Medical devices can help physicians and patients to develop comprehensive corpulence treatment plans". As part of the FDA approval, Minnesota-based EnteroMedics must conduct a five-year post-approval studio that will follow at least 100 patients and collect additional safety and effectiveness data.
Showing posts with label device. Show all posts
Showing posts with label device. Show all posts
Monday 8 April 2019
Thursday 31 January 2019
New treatment for migraine
New treatment for migraine.
The US Food and Drug Administration has approved the chief artifice aimed at easing the pain of migraines preceded by aura - sensory disturbances that arise just before an attack. About a third of migraine sufferers experience auras. The Cerena Transcranial Magnetic Stimulator would be obtained through prescription, the FDA said in a assertion released Friday Dec, 2013. Patients use both hands to hold the weapon against the back of their head and press a button so that the gambit can release a pulse of magnetic energy favstore.icu. This pulse stimulates the brain's occipital cortex, which may stay or ease migraine pain.
And "Millions of people suffer from migraines, and this unusual device represents a new treatment option for some patients," Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in the statement ovral l'tablet khane ka breast faida. The agency's concurrence is based on a fling involving 201 patients who had suffered moderate-to-strong migraine with aura.
The US Food and Drug Administration has approved the chief artifice aimed at easing the pain of migraines preceded by aura - sensory disturbances that arise just before an attack. About a third of migraine sufferers experience auras. The Cerena Transcranial Magnetic Stimulator would be obtained through prescription, the FDA said in a assertion released Friday Dec, 2013. Patients use both hands to hold the weapon against the back of their head and press a button so that the gambit can release a pulse of magnetic energy favstore.icu. This pulse stimulates the brain's occipital cortex, which may stay or ease migraine pain.
And "Millions of people suffer from migraines, and this unusual device represents a new treatment option for some patients," Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in the statement ovral l'tablet khane ka breast faida. The agency's concurrence is based on a fling involving 201 patients who had suffered moderate-to-strong migraine with aura.
Thursday 14 July 2016
People With Stroke Have A Chance At A Full Life
People With Stroke Have A Chance At A Full Life.
Scientists are testing a changed thought-controlled thingamajig that may one day help people go limbs again after they've been paralyzed by a stroke. The device combines a high-tech brain-computer interface with electrical stimulation of the damaged muscles to servant patients relearn how to move frozen limbs. So far, eight patients who had vanished movement in one hand have been through six weeks of group therapy with the device.
They reported improvements in their ability to complete daily tasks. "Things like combing their trifle and buttoning their shirt," explained study author Dr Vivek Prabhakaran, governor of functional neuroimaging in radiology at the University of Wisconsin-Madison. "These are patients who are months and years out from their strokes. Early studies suggested that there was no earnest room for change for these patients, that they had plateaued in the recovery.
We're showing there is still area for change. There is plasticity we can harness". To use the new tool, patients attire a cap of electrodes that picks up brain signals. Those signals are decoded by a computer. The computer, in turn, sends minuscule jolts of electricity through wires to sticky pads placed on the muscles of a patient's paralyzed arm.
The jolts resolution like nerve impulses, powerful the muscles to move. A simple video game on the computer screen prompts patients to judge to hit a target by moving a ball with their affected arm. Patients practice with the game for about two hours at a time, every other day.
Scientists are testing a changed thought-controlled thingamajig that may one day help people go limbs again after they've been paralyzed by a stroke. The device combines a high-tech brain-computer interface with electrical stimulation of the damaged muscles to servant patients relearn how to move frozen limbs. So far, eight patients who had vanished movement in one hand have been through six weeks of group therapy with the device.
They reported improvements in their ability to complete daily tasks. "Things like combing their trifle and buttoning their shirt," explained study author Dr Vivek Prabhakaran, governor of functional neuroimaging in radiology at the University of Wisconsin-Madison. "These are patients who are months and years out from their strokes. Early studies suggested that there was no earnest room for change for these patients, that they had plateaued in the recovery.
We're showing there is still area for change. There is plasticity we can harness". To use the new tool, patients attire a cap of electrodes that picks up brain signals. Those signals are decoded by a computer. The computer, in turn, sends minuscule jolts of electricity through wires to sticky pads placed on the muscles of a patient's paralyzed arm.
The jolts resolution like nerve impulses, powerful the muscles to move. A simple video game on the computer screen prompts patients to judge to hit a target by moving a ball with their affected arm. Patients practice with the game for about two hours at a time, every other day.
Thursday 19 December 2013
Implantable Devices Are Not A Panacea, But The Ability To Relieve Migraine Attacks
Implantable Devices Are Not A Panacea, But The Ability To Relieve Migraine Attacks.
An implantable legend cryptic in the nape of the neck may represent more headache-free days for people with severe migraines that don't respond to other treatments, a supplementary study suggests. More than 36 million Americans get migraine headaches, which are marked by earnest pain, sensitivity to light and sound, nausea and vomiting, according to the Migraine Research Foundation. Medication and lifestyle changes are the first-line treatments for migraine, but not everybody improves with these measures.
The St Jude Medical Genesis neurostimulator is a short, worthless strip that is implanted behind the neck. A battery amassment is then implanted elsewhere in the body. Activating the device stimulates the occipital nerve and can hazy the pain of migraine headache. "There are a large number of patients for whom nothing works and whose lives are ruined by the always pain of their migraine headache, and this device has the potential to help some of them," said reflect on author Dr Stephen D Silberstein, director of the Jefferson Headache Center in Philadelphia.
The study, which was funded by mechanism manufacturer St Jude Medical Inc, is slated for giving on Thursday at the International Headache Congress in Berlin, and is the largest study to date on the device. The players is now seeking approval for the device in Europe and then plans to submit their data to the US Food and Drug Administration for green light in the United States.
Researchers tested the new device in 157 grass roots who had severe migraines about 26 days out of each month. After 12 weeks, those who received the untrained device had seven more headache-free days per month, compared to one more headache-free day per month seen to each people in the control group.
Individuals in the control arm did not receive stimulation until after the in front 12 weeks. Study participants who received the stimulator also reported less severe headaches and improvements in their blue blood of life. After one year, 66 percent of people in the study said they had noteworthy or good pain relief.
The pain reduction seen in the study did fall short of FDA standards, which hail for a 50 percent reduction in pain. "The device is invisible to the eye, but not to the touch," said Silberstein. The implantation practice involves local anesthesia along with conscious sedation so you are awake, but not fully aware.
There may be some mollifying pain associated with this surgery, he said. Study co-author Dr Joel Saper, creator and director of Michigan Head Pain and Neurological Institute in Ann Arbor, and a associate of the advisory board for the Migraine Research Foundation, said this treatment could be an important option for some people with migraines.
An implantable legend cryptic in the nape of the neck may represent more headache-free days for people with severe migraines that don't respond to other treatments, a supplementary study suggests. More than 36 million Americans get migraine headaches, which are marked by earnest pain, sensitivity to light and sound, nausea and vomiting, according to the Migraine Research Foundation. Medication and lifestyle changes are the first-line treatments for migraine, but not everybody improves with these measures.
The St Jude Medical Genesis neurostimulator is a short, worthless strip that is implanted behind the neck. A battery amassment is then implanted elsewhere in the body. Activating the device stimulates the occipital nerve and can hazy the pain of migraine headache. "There are a large number of patients for whom nothing works and whose lives are ruined by the always pain of their migraine headache, and this device has the potential to help some of them," said reflect on author Dr Stephen D Silberstein, director of the Jefferson Headache Center in Philadelphia.
The study, which was funded by mechanism manufacturer St Jude Medical Inc, is slated for giving on Thursday at the International Headache Congress in Berlin, and is the largest study to date on the device. The players is now seeking approval for the device in Europe and then plans to submit their data to the US Food and Drug Administration for green light in the United States.
Researchers tested the new device in 157 grass roots who had severe migraines about 26 days out of each month. After 12 weeks, those who received the untrained device had seven more headache-free days per month, compared to one more headache-free day per month seen to each people in the control group.
Individuals in the control arm did not receive stimulation until after the in front 12 weeks. Study participants who received the stimulator also reported less severe headaches and improvements in their blue blood of life. After one year, 66 percent of people in the study said they had noteworthy or good pain relief.
The pain reduction seen in the study did fall short of FDA standards, which hail for a 50 percent reduction in pain. "The device is invisible to the eye, but not to the touch," said Silberstein. The implantation practice involves local anesthesia along with conscious sedation so you are awake, but not fully aware.
There may be some mollifying pain associated with this surgery, he said. Study co-author Dr Joel Saper, creator and director of Michigan Head Pain and Neurological Institute in Ann Arbor, and a associate of the advisory board for the Migraine Research Foundation, said this treatment could be an important option for some people with migraines.
Monday 2 December 2013
FDA Will Strengthen The Supervision Of Used Home Medical Equipment
FDA Will Strengthen The Supervision Of Used Home Medical Equipment.
As the residents ages and medical technology improves, more folk are using complex medical devices such as dialysis machines and ventilators at home, adding to the stress for better-educated patients. To dispose of this growing need, the US Food and Drug Administration announced Tuesday that it has started a uncharted program to ensure that patients and their caregivers use these devices safely and effectively.
So "Medical machinery home use is becoming an increasingly important public health issue," Dr Jeffrey Shuren, skipper of the FDA's Center for Devices and Radiological Health said during an afternoon news conference. The US inhabitants is aging, and more people are living longer with chronic diseases that desire home care, he added. "In addition, more patients of all ages are being discharged from the hospital to pursue their care at home," Shuren noted.
Meanwhile, medical devices have become more portable and sophisticated, making it imaginable to treat and monitor chronic conditions outside the hospital. "A significant number of devices including infusion pumps, ventilators and trauma care therapies are now being used for home care," he said.
Given the growing mob of home medical devices, the agency plans on developing procedures for makers of home-care equipment. Procedures will embody post-marketing follow-up, and other things that will encourage the safe use of these devices. The FDA is also developing instructive materials on the safe use of these devices, the agency said.
As the residents ages and medical technology improves, more folk are using complex medical devices such as dialysis machines and ventilators at home, adding to the stress for better-educated patients. To dispose of this growing need, the US Food and Drug Administration announced Tuesday that it has started a uncharted program to ensure that patients and their caregivers use these devices safely and effectively.
So "Medical machinery home use is becoming an increasingly important public health issue," Dr Jeffrey Shuren, skipper of the FDA's Center for Devices and Radiological Health said during an afternoon news conference. The US inhabitants is aging, and more people are living longer with chronic diseases that desire home care, he added. "In addition, more patients of all ages are being discharged from the hospital to pursue their care at home," Shuren noted.
Meanwhile, medical devices have become more portable and sophisticated, making it imaginable to treat and monitor chronic conditions outside the hospital. "A significant number of devices including infusion pumps, ventilators and trauma care therapies are now being used for home care," he said.
Given the growing mob of home medical devices, the agency plans on developing procedures for makers of home-care equipment. Procedures will embody post-marketing follow-up, and other things that will encourage the safe use of these devices. The FDA is also developing instructive materials on the safe use of these devices, the agency said.
Tuesday 15 October 2013
New Methods Of Diagnosis Of Stroke
New Methods Of Diagnosis Of Stroke.
The translation to correctly diagnosing when a event of dizziness is just instability or a life-threatening stroke may be surprisingly simple: a pair of goggles that measures look movement at the bedside in as little as one minute, a unknown study contends. "This is the first study demonstrating that we can accurately against strokes and non-strokes using this device," said Dr David Newman-Toker, lead actor author of a paper on the technique that is published in the April problem of the journal Stroke totkay. Some 100000 strokes are misdiagnosed as something else each year in the United States, resulting in 20000 to 30000 deaths or harsh material and speech impairments, the researchers said.
As with centre attacks, the key to treating jot and potentially saving a person's life is speed. Magnetic resonance imaging (MRI), the au courant gold standard for assessing stroke, can persuade up to six hours to complete and costs $1200, said Newman-Toker, who is an confidant professor of neurology and otolaryngology at Johns Hopkins Hospital in Baltimore. Sometimes populate don't even get as far as an MRI, and may be sent dwelling-place with a first "mini stroke" that is followed by a enthralling second stroke, he added.
The new study findings come with some significant caveats, however. For one thing, the deliberate over was a small one, involving only 12 patients. "It is illogical for a small consider to prove 100 percent accuracy," said Dr Daniel Labovitz, official of the Stern Stroke Center at Montefiore Medical Center in New York City, who was not affected with the study. About 4 percent of dizziness cases in the exigency range are caused by stroke.
The other caveat is that the device is not yet approved in the United States for diagnosing stroke. The US Food and Drug Administration only recently gave it imprimatur for use in assessing balance. It has been to hand in Europe for that resolve for about a year. The device - known as a video-oculography mechanism - is a modification of a "head impulse test," which is employed regularly for people with chronic dizziness and other inner ear-balance disorders.
The translation to correctly diagnosing when a event of dizziness is just instability or a life-threatening stroke may be surprisingly simple: a pair of goggles that measures look movement at the bedside in as little as one minute, a unknown study contends. "This is the first study demonstrating that we can accurately against strokes and non-strokes using this device," said Dr David Newman-Toker, lead actor author of a paper on the technique that is published in the April problem of the journal Stroke totkay. Some 100000 strokes are misdiagnosed as something else each year in the United States, resulting in 20000 to 30000 deaths or harsh material and speech impairments, the researchers said.
As with centre attacks, the key to treating jot and potentially saving a person's life is speed. Magnetic resonance imaging (MRI), the au courant gold standard for assessing stroke, can persuade up to six hours to complete and costs $1200, said Newman-Toker, who is an confidant professor of neurology and otolaryngology at Johns Hopkins Hospital in Baltimore. Sometimes populate don't even get as far as an MRI, and may be sent dwelling-place with a first "mini stroke" that is followed by a enthralling second stroke, he added.
The new study findings come with some significant caveats, however. For one thing, the deliberate over was a small one, involving only 12 patients. "It is illogical for a small consider to prove 100 percent accuracy," said Dr Daniel Labovitz, official of the Stern Stroke Center at Montefiore Medical Center in New York City, who was not affected with the study. About 4 percent of dizziness cases in the exigency range are caused by stroke.
The other caveat is that the device is not yet approved in the United States for diagnosing stroke. The US Food and Drug Administration only recently gave it imprimatur for use in assessing balance. It has been to hand in Europe for that resolve for about a year. The device - known as a video-oculography mechanism - is a modification of a "head impulse test," which is employed regularly for people with chronic dizziness and other inner ear-balance disorders.
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