- FDA cleared and CE approved therapy based onrepetitive Transcranial Magnetic Stimulation (rTMS)- FDA cleared and CE approved therapy based onrepetitive Transcranial Magnetic Stimulation (rTMS)

MagVita TMS Therapy®

Eff ective treatment of Major Depressive Disorder– an alternative to antidepressants

Please note that this brochure is not intended for US audiences.

Indications for use

MagVita TMS Therapy® isFDA cleared for:“Treatment of Major DepressiveDisorder in adult patients whohave failed to receive satisfac-tory improvement from prior antidepressant medication in the current episode.”

MagVita TMS Therapy® isCE approved for:“Treatment of Major DepressiveDisorder in adult patients who have failed to achieve satisfac-tory improvement from two prior antidepressant medications, at or above the minimal eff ective dose and duration in the current episode.”

During MagVita TMS Therapy the patient is comfortably seated with a vacuum pillow around the neck to giveoptimal support of the head. A personal cap is used to mark the treatment spot and hereby ensuring correct positioning of the coil delivering the magnetic pulses.

Excellent response and remission raterTMS is an eff ective and non-invasive alternative for the large number of patients not responding to medication or who cannot tolerate the side eff ects ofmedication. rTMS does not require anesthesia – and is not to be confused withECT (Electro Convulsive Therapy).

Clinical trials and experience from clinics off ering this treatment show excel-lent results in terms of response and remission rate. The MagVita TMS Therapy system delivers non-invasive, magnetic pulses through a magnetic coil to stimulate nerve cells in the part of the brain controlling the mood. The rapid change in the magnetic fi eld induces a current, and if the current induced is of suffi cient amplitude and duration, it will activate neurons.

Research shows that rTMS leads to increases in blood fl ow, increases inglucose metabolism and increases the level of the neurotransmitters (dopa-mine and glutamate) in the stimulated regions of the brain. It is known thatpeople suff ering from depression have a reduced blood fl ow, glucose metabolism and generalized activity in the part of the brain that contributes to mood. Repeated stimulation of this area of the brain can have an antide-pressant eff ect on people suff ering from major depression.

A large meta-analysis comparing rTMS to sham treatment showed a meaneff ect size for rTMS in depression of 55% which is high compared to meaneff ect sizes for pharmacotherapy between 17-46%. A double-blind, placebo-controlled trial fi nds that 61% of patients respond to rTMS therapy with asignifi cant reduction in HAM-D score over the 4-6 week treatment time.

What is repetitive Transcranial MagneticStimulation (rTMS)?

Often patients suff ering from major depression obtain no relief, or inadequate relieffrom antidepressants. In many cases, drug therapies induce side eff ects thatresult in noncompliance.

MagVita TMS Therapy based on repetitive Transcranial Magnetic Stimulation (rTMS)is an eff ective and easy-to-use alternative: • Series of pulsed magnetic stimuli to the brain• Non-invasive procedure – no anesthetics• Outpatient treatment• Excellent tolerability• Free from common antidepressant side eff ects• Can be used in combination with typical antidepressants • Cognitive function not aff ected• Patient able to resume daily activities right after treatment

Eff ective and short treatment periodNumerous independent clinical studies have demonstrated that rTMS is an eff ectivetherapy for the treatment of resistant major depression.

• Onset of therapeutic eff ect in as little as 2 weeks• Short treatment period of normally 4 to 6 weeks• >30% remitters and >50% responders (refractory patient group)

Simple treatment procedure The MagVita TMS Therapy treatment protocol consists of repeated cycles of rTMS followed by rest periods.

A full MagVita TMS Therapy consists of:

• An initial session which includes the determination of the patient’s individual stimu-lation level (motor threshold determination)

• 5 treatment sessions per week during a period of normally 4-6 weeks• Maintenance treatment if needed

Diagnosis and initial session are performed by a psychiatrist. The remaining treat-ment sessions are typically conducted by trained personnel under the supervision of a psychiatrist.

Easy to get started – also for small clinicsDepending on your situation and how many patients you expect to treat per day,MagVenture has the right solution for you. From our entry-level solution ideal forsmall or start-up clinics to our high-performance solutions, we have the right stimula-tor for you. All of our MagPro Family stimulators can run the MagVita TMS Therapy.

The MagVita TMS Therapy system has been especially designed for therapeutic use.Once you have been trained by MagVenture, you are ready to off er the treatment.

Our system is easy to use:• Position patient, set treatment protocol and press start• Pre-defi ned treatment protocols • Includes tools for accurate treatment spot determination• Easy to pause and resume the treatment

Anti-depressants

rTMS

Anxiety •

Blurred vision •

Diarrhea/constipation •

Dizziness • • (transient)

Dry mouth •

Feeling sick •

Headache • • (transient)

Insomnia/drowsiness •

Nausea •

Sexual dysfunction •

Shaking/trembling •

Sweating •

Weight gain •

• Common side eff ects of diff erent therapies

Why you should off er MagVita TMS Therapy®

to your patients

Get more information

Contact us for more information if you consider off ering rTMS depression treatmentto your patients. You can also fi nd more information about the MagVita TMS Therapysystem on www.magventure.com

Please note that this brochure is not intended for US audiences

©MagVenture a/s • 511-0102 rev. 2.3 • www.magventure.com

MagVita TMS Therapy fi lmDo you want to learn more about MagVita TMS Therapy ? Scan the code for a step-by-step guide of the system.

MagVenture A/SLucernemarken 15DK-3520 FarumDenmark

Phone: +45 4499 8444info@magventure.comwww.magventure.com