Treating Morbid Extreme Obesity.
A first-of-its-kind instil that curbs the appetence by electrically stimulating stomach nerves was approved Wednesday by the US Food and Drug Administration. The Maestro Rechargeable System is intended to treat morbid (extreme) obesity, gimmick manufacturer EnteroMedics Inc said in its application for FDA approval. The implant sends electrical signals to nerves around the yearning that help control digestion. These signals close off the nerves, decreasing hunger pangs and making the person feel full.
The FDA approved the tool 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 kidney 2 diabetes. BMI is a ratio that determines body fat based on a person's culmination and weight. For example, a person who's 5 feet, 8 inches lofty and weighs 230 pounds has a BMI of 35. 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 yield weight with a traditional weight loss program, the FDA said. The coat of arms is the first FDA-approved obesity device since 2007. In clinical trials, tribe with a Maestro implant lost an average 8,5 percent more weight after one year than others who received a dissemble implant. About half of the implanted patients lost at least 20 percent of their residual weight, and 38 percent lost at least 25 percent of their nimiety weight.
EnteroMedics reported that people with fake implants regained about 40 percent of the heft they had lost within six months of the trial's end, while the people with the Maestro device appeared to withstand their weight loss. According to the CDC, more than one-third of all US adults are obese, and people with grossness are at increased risk of heart disease, stroke, type 2 diabetes and certain cancers.
And "Obesity and its mutual medical conditions are major public health problems," Dr William Maisel, overseer scientist in the FDA's Center for Devices and Radiological Health, said in an intermediation news release. "Medical devices can help physicians and patients to develop comprehensive rotundity treatment plans". As part of the FDA approval, Minnesota-based EnteroMedics must conduct a five-year post-approval about 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
Wednesday 22 May 2019
Friday 17 August 2018
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 occult in the nape of the neck may penurious more headache-free days for people with severe migraines that don't respond to other treatments, a reborn study suggests. More than 36 million Americans get migraine headaches, which are marked by impetuous 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 Dick improves with these measures.
The St Jude Medical Genesis neurostimulator is a short, slim strip that is implanted behind the neck. A battery drove is then implanted elsewhere in the body. Activating the device stimulates the occipital nerve and can shade the pain of migraine headache. "There are a large number of patients for whom nothing works and whose lives are ruined by the quotidian pain of their migraine headache, and this device has the potential to help some of them," said think over author Dr Stephen D Silberstein, director of the Jefferson Headache Center in Philadelphia.
The study, which was funded by cognizance manufacturer St Jude Medical Inc, is slated for performance on Thursday at the International Headache Congress in Berlin, and is the largest study to date on the device. The crowd is now seeking approval for the device in Europe and then plans to submit their data to the US Food and Drug Administration for go-ahead in the United States.
Researchers tested the new device in 157 society who had severe migraines about 26 days out of each month. After 12 weeks, those who received the unheard of device had seven more headache-free days per month, compared to one more headache-free day per month seen in the midst people in the control group.
Individuals in the control arm did not receive stimulation until after the sooner 12 weeks. Study participants who received the stimulator also reported less severe headaches and improvements in their mark of life. After one year, 66 percent of people in the study said they had magic or good pain relief.
The pain reduction seen in the study did fall short of FDA standards, which invite for a 50 percent reduction in pain. "The device is invisible to the eye, but not to the touch". The implantation standard operating procedure involves local anesthesia along with conscious sedation so you are awake, but not fully aware.
There may be some subdued pain associated with this surgery. Study co-author Dr Joel Saper, go to Davy Jones's locker and director of Michigan Head Pain and Neurological Institute in Ann Arbor, and a fellow of the advisory board for the Migraine Research Foundation, said this therapy could be an important option for some grass roots with migraines.
An implantable legend occult in the nape of the neck may penurious more headache-free days for people with severe migraines that don't respond to other treatments, a reborn study suggests. More than 36 million Americans get migraine headaches, which are marked by impetuous 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 Dick improves with these measures.
The St Jude Medical Genesis neurostimulator is a short, slim strip that is implanted behind the neck. A battery drove is then implanted elsewhere in the body. Activating the device stimulates the occipital nerve and can shade the pain of migraine headache. "There are a large number of patients for whom nothing works and whose lives are ruined by the quotidian pain of their migraine headache, and this device has the potential to help some of them," said think over author Dr Stephen D Silberstein, director of the Jefferson Headache Center in Philadelphia.
The study, which was funded by cognizance manufacturer St Jude Medical Inc, is slated for performance on Thursday at the International Headache Congress in Berlin, and is the largest study to date on the device. The crowd is now seeking approval for the device in Europe and then plans to submit their data to the US Food and Drug Administration for go-ahead in the United States.
Researchers tested the new device in 157 society who had severe migraines about 26 days out of each month. After 12 weeks, those who received the unheard of device had seven more headache-free days per month, compared to one more headache-free day per month seen in the midst people in the control group.
Individuals in the control arm did not receive stimulation until after the sooner 12 weeks. Study participants who received the stimulator also reported less severe headaches and improvements in their mark of life. After one year, 66 percent of people in the study said they had magic or good pain relief.
The pain reduction seen in the study did fall short of FDA standards, which invite for a 50 percent reduction in pain. "The device is invisible to the eye, but not to the touch". The implantation standard operating procedure involves local anesthesia along with conscious sedation so you are awake, but not fully aware.
There may be some subdued pain associated with this surgery. Study co-author Dr Joel Saper, go to Davy Jones's locker and director of Michigan Head Pain and Neurological Institute in Ann Arbor, and a fellow of the advisory board for the Migraine Research Foundation, said this therapy could be an important option for some grass roots with migraines.
Friday 29 June 2018
New Treatment For Migraine
New Treatment For Migraine.
The US Food and Drug Administration has approved the inception logotype aimed at easing the pain of migraines preceded by aura - sensory disturbances that befall 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 disclosure released Friday Dec, 2013. Patients use both hands to hold the manoeuvre against the back of their head and press a button so that the insigne can release a pulse of magnetic energy. This pulse stimulates the brain's occipital cortex, which may lodge or ease migraine pain.
And "Millions of people suffer from migraines, and this unfamiliar 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. The agency's green light is based on a exploratory involving 201 patients who had suffered moderate-to-strong migraine with aura.
The US Food and Drug Administration has approved the inception logotype aimed at easing the pain of migraines preceded by aura - sensory disturbances that befall 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 disclosure released Friday Dec, 2013. Patients use both hands to hold the manoeuvre against the back of their head and press a button so that the insigne can release a pulse of magnetic energy. This pulse stimulates the brain's occipital cortex, which may lodge or ease migraine pain.
And "Millions of people suffer from migraines, and this unfamiliar 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. The agency's green light is based on a exploratory involving 201 patients who had suffered moderate-to-strong migraine with aura.
Tuesday 23 December 2014
New Methods Of Diagnosis Of Stroke
New Methods Of Diagnosis Of Stroke.
The style to correctly diagnosing when a covering of dizziness is just vertigo or a life-threatening stroke may be surprisingly simple: a pair of goggles that measures knowledge movement at the bedside in as little as one minute, a new study contends. "This is the beginning study demonstrating that we can accurately discriminate strokes and non-strokes using this device," said Dr David Newman-Toker, leading author of a paper on the technique that is published in the April issue of the monthly Stroke. Some 100000 strokes are misdiagnosed as something else each year in the United States, resulting in 20000 to 30000 deaths or tough physical and speech impairments, the researchers said.
As with nerve attacks, the key to treating stroke and potentially saving a person's life is speed. Magnetic resonance imaging (MRI), the on the qui vive gold standard for assessing stroke, can take up to six hours to unmixed and costs $1200, said Newman-Toker, who is an associate professor of neurology and otolaryngology at Johns Hopkins Hospital in Baltimore. Sometimes mortals 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 devastating second stroke, he added.
The new study findings come with some significant caveats, however. For one thing, the reflect on was a small one, involving only 12 patients. "It is outlandish for a small study to prove 100 percent accuracy," said Dr Daniel Labovitz, cicerone of the Stern Stroke Center at Montefiore Medical Center in New York City, who was not confusing with the study. About 4 percent of dizziness cases in the exigency room 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 okay for use in assessing balance. It has been at in Europe for that purpose for about a year. The device - known as a video-oculography system - is a modification of a "head impulse test," which is used regularly for people with chronic dizziness and other inner ear-balance disorders.
The style to correctly diagnosing when a covering of dizziness is just vertigo or a life-threatening stroke may be surprisingly simple: a pair of goggles that measures knowledge movement at the bedside in as little as one minute, a new study contends. "This is the beginning study demonstrating that we can accurately discriminate strokes and non-strokes using this device," said Dr David Newman-Toker, leading author of a paper on the technique that is published in the April issue of the monthly Stroke. Some 100000 strokes are misdiagnosed as something else each year in the United States, resulting in 20000 to 30000 deaths or tough physical and speech impairments, the researchers said.
As with nerve attacks, the key to treating stroke and potentially saving a person's life is speed. Magnetic resonance imaging (MRI), the on the qui vive gold standard for assessing stroke, can take up to six hours to unmixed and costs $1200, said Newman-Toker, who is an associate professor of neurology and otolaryngology at Johns Hopkins Hospital in Baltimore. Sometimes mortals 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 devastating second stroke, he added.
The new study findings come with some significant caveats, however. For one thing, the reflect on was a small one, involving only 12 patients. "It is outlandish for a small study to prove 100 percent accuracy," said Dr Daniel Labovitz, cicerone of the Stern Stroke Center at Montefiore Medical Center in New York City, who was not confusing with the study. About 4 percent of dizziness cases in the exigency room 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 okay for use in assessing balance. It has been at in Europe for that purpose for about a year. The device - known as a video-oculography system - is a modification of a "head impulse test," which is used regularly for people with chronic dizziness and other inner ear-balance disorders.
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