FDA purifies 3-minute, non-pharmaceutical depression treatment



(Photo: https://mma.prnewswire.com/media/733551/Picture_magventure.jpg)

TMS has been approved by the FDA since 2008 for a treatment-resistant depressive disorder. Since then, more than 1,000 psychiatric clinics have emerged in the US. Most private health insurance companies also cover the treatment. The relatively long treatment sessions, however, not only limited the treatment capacity for TMS practices, but also prevented a more general spread. Until now, each session was a maximum of 37 minutes long, with a total of 20-30 sessions required. The new treatment form, known as Theta Burst Stimulation (TBS), offers an important advantage: time. A TBS treatment session lasts only 3 minutes and thus has the potential to revolutionize the clinical field of TMS.

"We called it" Express TMS[[[[®]" because that's what it is: a treatment that is just as safe and effective for the treatment of depression as conventional TMS, only much, much faster. We are happy and proud to be the first in the US to receive FDA approval for this revolutionary treatment supported by substantial scientific evidence. Our current treatment system, MagVenture TMS Therapy, can be easily upgraded with the new Express TMS option. This will enable our many customers to treat many more patients per day without having to invest in another TMS device. For people who need treatment, this will also be a huge benefit, because the treatment now takes less time, "says Kerry Rome, Vice President of Sales, MagVenture Inc.

The new FDA approved treatment protocol, currently only offered by MagVenture, is based on a new clinical study called the THREE-D study, led by a collaboration of three leading research hospitals in Canada (CAMH, UHN and UBC). It is the largest, double-blind, randomized TMS study to date, with 414 participants suffering from a depressive disorder. Response / remission rates were 33% for those who received the TBS protocol, while 50% had an improvement in their depressive symptoms. These percentages are comparable to the standard, longer TMS protocol. The article was published in The Lancet in 2018.

What is TMS?

Transcranial magnetic stimulation, or TMS, is an effective, non-invasive alternative to the large number of patients who do not respond to medication. It requires no anesthesia – and should not be confused with ECT (Electro Convulsive Therapy).

MagVenture TMS therapy provides magnetic pulses to stimulate nerve cells in the part of the brain that controls the mood. The rapid change in the magnetic field induces a current, and if the induced current is of sufficient amplitude and duration, it will stimulate neurons.

Both TMS and TBS are based on these principles. The difference lies in the way the magnetic pulses are delivered.

MagVenture is the only company with a FDA-approved Theta Burst solution for the treatment of depression, "Express TMS"®.

MagVenture& # 39;s FDA approval: *The MagVita TMS therapy system indicated for the treatment of major depressive disorder in adult patients who have not received a satisfactory improvement in previous antidepressants in the current episode.

FDA approval

MagVenture is a Danish medical device company, founded in 2007, and specializes in non-invasive magnetic stimulation systems for the treatment of depressive disorders. Because we were founded in research, we have partnerships with the world's leading TMS researchers in the fields of neurophysiology, neurology, cognitive neuroscience, rehabilitation and psychiatry.

Our advanced series of coils and magnetic stimulators are sold on the world market through direct sales subsidiaries Germany, the UK and the United States, and through a global network of distributors Europe, Asia, Middle East and the America & # 39; s.

http://www.magventure.com

SOURCE MagVenture, Inc


Source link

FDA purifies 3-minute, non-pharmaceutical depression treatment



(Photo: https://mma.prnewswire.com/media/733551/Picture_magventure.jpg)

TMS has been approved by the FDA since 2008 for a treatment-resistant depressive disorder. Since then, more than 1,000 psychiatric clinics have emerged in the US. Most private health insurance companies also cover the treatment. The relatively long treatment sessions, however, not only limited the treatment capacity for TMS practices, but also prevented a more general spread. Until now, each session was a maximum of 37 minutes long, with a total of 20-30 sessions required. The new treatment form, known as Theta Burst Stimulation (TBS), offers an important advantage: time. A TBS treatment session lasts only 3 minutes and thus has the potential to revolutionize the clinical field of TMS.

"We called it" Express TMS[[[[®]" because that's what it is: a treatment that is just as safe and effective for the treatment of depression as conventional TMS, only much, much faster. We are happy and proud to be the first in the US to receive FDA approval for this revolutionary treatment supported by substantial scientific evidence. Our current treatment system, MagVenture TMS Therapy, can be easily upgraded with the new Express TMS option. This will enable our many customers to treat many more patients per day without having to invest in another TMS device. For people who need treatment, this will also be a huge benefit, because the treatment now takes less time, "says Kerry Rome, Vice President of Sales, MagVenture Inc.

The new FDA approved treatment protocol, currently only offered by MagVenture, is based on a new clinical study called the THREE-D study, led by a collaboration of three leading research hospitals in Canada (CAMH, UHN and UBC). It is the largest, double-blind, randomized TMS study to date, with 414 participants suffering from a depressive disorder. Response / remission rates were 33% for those who received the TBS protocol, while 50% had an improvement in their depressive symptoms. These percentages are comparable to the standard, longer TMS protocol. The article was published in The Lancet in 2018.

What is TMS?

Transcranial magnetic stimulation, or TMS, is an effective, non-invasive alternative to the large number of patients who do not respond to medication. It requires no anesthesia – and should not be confused with ECT (Electro Convulsive Therapy).

MagVenture TMS therapy provides magnetic pulses to stimulate nerve cells in the part of the brain that controls the mood. The rapid change in the magnetic field induces a current, and if the induced current is of sufficient amplitude and duration, it will stimulate neurons.

Both TMS and TBS are based on these principles. The difference lies in the way the magnetic pulses are delivered.

MagVenture is the only company with a FDA-approved Theta Burst solution for the treatment of depression, "Express TMS"®.

MagVenture& # 39;s FDA approval: *The MagVita TMS therapy system indicated for the treatment of major depressive disorder in adult patients who have not received a satisfactory improvement in previous antidepressants in the current episode.

FDA approval

MagVenture is a Danish medical device company, founded in 2007, and specializes in non-invasive magnetic stimulation systems for the treatment of depressive disorders. Because we were founded in research, we have partnerships with the world's leading TMS researchers in the fields of neurophysiology, neurology, cognitive neuroscience, rehabilitation and psychiatry.

Our advanced series of coils and magnetic stimulators are sold on the world market through direct sales subsidiaries Germany, the UK and the United States, and through a global network of distributors Europe, Asia, Middle East and the America & # 39; s.

http://www.magventure.com

SOURCE MagVenture, Inc


Source link

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