MagPro Stimulator (the TMS device) with depression protocol pre-defined.
What is included in the MagVita TMS Therapy system?
MagVenture has received FDA clearance for both TBS (treatment time 3 minutes) and standard TMS (treatment time between 18.8-37.5 min)
For TBS, the core of the system consists of:
- Liquid cooled Cool-B70 coil for MT determination and TMS treatment
For standard TMS, the core of the system consists of:
- C-B60 coil for MT determination
- Liquid cooled Cool-B65 coil for TMS treatment
The system furthermore includes:
- Trolley for the stimulator
- Comfortable treatment chair (optional component)
- Head stabilization system to support and keep the patient stable during the rTMS procedure (optional component)
- Articulated steel arm for coil positioning
- Device including coil for treatment location based on MT hotspot
- Cloth caps to facilitate easy marking of treatment location and repositioning on the patients head after the initial TMS session
- Accessories for coil storage & cap marking
- Power supply
It is possible to get the Patient Management system MagVita 360 which is an optional add-on to the MagVita TMS Therapy system.
What is the cost per treatment with the MagVita TMS Therapy system?
The “consumable cost” per session, using the MagVita TMS Therapy System is approximately $4.38 for standard TMS and less than $1.50 for TBS. This price is based on the complete TMS depression therapy protocol consisting of 30 treatments and includes the replacement of the treatment coil as well as an individual treatment cap for each patient. For further details, please see breakdown of cost below.
The treatment coil used during the therapeutic procedure has a lifespan of approximately 11,250 treatment sessions before replacement. The cost per treatment is therefore approximately $0.90. In addition, each patient receiving the treatment is assigned a treatment cap. The cap is used throughout the 30 session course of treatment. At a cost of $14 per cap, an additional cost of $0.47 is added per treatment.
The treatment coil used during the therapeutic procedure has a lifespan of approximately 2,250 treatment sessions before replacement. The cost per treatment is therefore approximately $3.91. In addition, each patient receiving the MagVita TMS Therapy treatment is assigned a treatment cap. The cap is used throughout the 30 session course of treatment. At a cost of $14 per cap, an additional cost of $0.47 is added per treatment.
Is reimbursement available for TMS Therapy delivered with the MagVita system?
rTMS procedures delivered with the MagVita TMS Therapy System are billed using the same CPT codes as procedures delivered with other FDA cleared TMS systems. As long as standards for medical necessity* are met, there is no rationale for insurance companies that cover rTMS as a medical procedure for the treatment of depression, to deny re-imbursement for therapy delivered with the MagVita system. However, different standards for medical necessity do exist and may vary from insurance company to insurance company.
* The MagVita system has been established and is recognized in the United States by the clearance granted to MagVenture to market the MagVita system as a device to be used for the delivery of rTMS for the treatment of depression by the US Food and Drug Administration (FDA). The MagVita TMS Therapy System is “indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressants in the current episode”.
Is it possible to lease the MagVita TMS system from MagVenture?
MagVenture can refer customers interested in leasing to a number of third party medical device financing partners. This also involves working with both customers and leasing partners to structure leases with competitive rates and affordable monthly payments.
Do I need a dedicated treatment room?
For practical reasons and concerns of patient privacy, a dedicated treatment room is highly recommended. The MagVita system has a footprint of approximately 3 square meters and the TMS procedure makes a clicking sound that would almost certainly interfere with other activities that might be conducted simultaneously in the same treatment space.
What is the delivery time after purchase of a MagVita TMS Therapy system?
The average delivery time is 4-6 weeks.
Where is the MagVita TMS system produced?
MagPro magnetic stimulators and transducer coils are manufactured by MagVenture’s sister company Tonica Elektronik at the companies’ shared address in Farum, (just outside Copenhagen) Denmark.
How is the correct treatment location on the patient’s head determined when using the MagVita system?
The MagVita TMS Therapy System includes a tool which provides the correct translation from the “Motor Threshold Hotspot” to the therapeutic treatment location on the left dorso-lateral pre-frontal cortex when it is used in conjunction with the included C-B60 coil (for motor threshold determination).
How does the MagVita TMS Therapy system ensure that the patient’s head does not move during treatment?
The MagVita TMS Therapy System offers a special system which not only stabilizes the patient’s head but also helps ensure that the patient is comfortable during the 37,5 minute treatment session. The system consists of a flexible pillow filled with small polystyrene balls. The pillow is molded around the patient’s head and neck before the air is evacuated. The pillow will hereby become rigid and will effectively support the patient’s head and prevent any side to side motion that might allow unwanted patient movement relative to the treatment coil. The treatment coil, which is placed on the front of the patient’s head, further stabilizes the patient’s head against any forward/ backward motion.
What is the FDA cleared protocol for treatment of Major Depressive Disorder with MagVita TMS Therapy?
TBS – (theta burst stimulation):
TBS stimulation is applied in 50Hz triplet bursts five times per second. It is an intermittent theta burst stimulation (iTBS) which means that the stimulations are delivered in a cycle of 2 seconds on and 8 seconds off. One treatment session consists of: 10 burst per train at 5Hz – duty circle: 2 seconds on, 8 seconds off, over 3 minutes and 9 seconds. One burst consists of triplets (3 pulses) of 50Hz and IPI (Inter pulse interval) of 20ms. The number of trains is 20 which provide a total of 600 pulses and 200 bursts in the treatment session.
MagVenture’s FDA clearance is a 510(k) “Substantial Equivalency” clearance with the Neurostar TMS therapy device from Neuronetics as the predicate device. One treatment session consists of 75 cycles of 4 seconds of 10Hz stimulation followed by between 11-26 seconds of rest. The stimulation intensity is 120% of the patient’s resting Motor Threshold (MT) value. The overall protocol results in a session duration of between 18.8- 37.5 minutes with a total of 3,000 pulses delivered. These sessions are repeated once daily, 5 times per week for 6 weeks.
What is the difference between TMS and TBS?
Theat burst stimulation (TBS) is a form of patterned TMS which makes it possible to induce strong and long-lasting effects using a lower stimulation intensity and a shorter time of stimulation compared to standard TMS protocols. This means that if you use TBS instead of standard TMS to treat your patients, you will be able to treat 5 times more patients which makes TBS depression treatment much more cost-effective.
In the FDA cleared TBS protocol, the theta burst stimulation is applied in 50Hz triplet bursts five times per second. It is an intermittent theta burst stimulation (iTBS) which means that the stimulations are delivered in a cycle of 2 seconds on and 8 seconds off. This pattern is found to have an excitatory effect whose potency matches or exceeds much longer sessions of standard TMS.
Does the MagVita system have a patient management system?
Yes – the MagVita 360 is a patient management system especially developed for use in a clinical settings. It is an optional add-on to the MagVita TMS Therapy. With the MagVita 360, it is possible to get anytime, anywhere access to the system from all platforms such as laptops and tablets. With the MagVita 360 you can manage your patient’s data, treat your patient as usual and log the data, track your patient’s treatment and use the report tool for reimbursement purposes.
How many patients can be seen, per day, with the MagVita TMS Therapy system?
TBS – Theta burst
The FDA cleared TBS protocol specifies a treatment session lasting 3 min and 9 seconds. Because of the highly efficient liquid cooling included in the MagVita TMS system, the patient throughput is very high as it is not necessary to wait for the system to cool down between treatments. It is possible to treat between 35-60 patients per day depending on the number of working hours. Based on a 10 minute slot per patient, it is possible to see 6 patients every hours.
The FDA cleared protocol u specifies a treatment session lasting between 18.8-37.5 minutes. Because the MagVita system relies on a remarkably efficient liquid coolant system to maintain the temperature of the coil, there is no need to delay operations between patients to allow the system to cool off between treatments. This allows for a high patient throughput and for high volume practices to see 15-20 patients per day, without any issues related to system heating.
How effective and safe is the MagVita TMS Therapy system?
The MagVita TMS Therapy system is as safe and effective as the predicate device for use in treatment of major depressive disorder as per the information supporting MagVenture’s 510(k) FDA clearance. The safety and efficacy of the MagPro TMS stimulator is supported by ample data from independent academic medical centers worldwide, where it has been used extensively in clinical practice for the treatment of Major Depressive Disorder
What kind of training does MagVenture provide with MagVita TMS purchase?
One day of onsite training is included with all MagVita purchases. The training includes a complete set-up of the system, training on the care and maintenance, navigation of the system interface, and clinical aspects of use, such as patient qualification (indication for use, contraindications), finding MT hotspot, determination of MT intensity level, location of treatment location based on MT hotspot, and safety preparedness in case of adverse events during TMS sessions.
Does MagVenture provide a certification of completion of training?
Yes, MagVenture issues certificates of completion of training for all individuals who complete the onsite training with MagVita and/or any other MagPro systems. The certificate testifies that the recipient has completed MagVenture’s training successfully.
How is new clinical staff trained in the MagVita system?
MagVenture offers training at a per diem cost, with clinical, technical and/or a service related focus. Contact MagVenture Inc. for further information.
Where can one find information about / register for other TMS courses?
TMS courses for those new to TMS as well as for advanced users are offered at a number of universities and other health education facilities around the world. In the US and Canada, TMS courses are presently offered at Harvard University (Boston), Duke University (North Carolina), TMS Health Education (San Francisco) and CAMH (Toronto). More locations are likely to be added due to increased demand.
What is the anticipated life of the MagVita TMS system?
The official lifetime of the MagVita TMS Therapy System as a medical device is 7 years. In practice, most MagVenture magnetic stimulator systems continue to function after expiration of their formal product lifetimes. The product lifetimes for MagPro stimulators/ systems is based largely on MagVenture’s ability to maintain a service inventory of integrated computer components for the stimulators and other computerized components of the systems. For stimulators and durable hardware components greater than seven years old, MagVenture offers repairs when possible, but is limited in many cases, by the availability of components for older devices.
Transducer coils used with MagPro/ MagVita systems have finite product lifetimes that are shorter than seven years. The coils supplied with the MagVita TMS Therapy System have absolute lifetimes of five years, or in the case of the liquid cooled “Cool-B65” treatment coil, potentially shorter, as the device has a built in pulse counter that limits the coil to a predefined usage limit based on number of pulses and intensity of stimulation for safety reasons. The predefined usage limit equates to approximately 2,250 treatment sessions.
Is the MagVita TMS Therapy system upgradable?
Software updates for MagPro systems including the MagVita TMS Therapy system are released periodically addressing identified software issues or adding potential functionalities that can be implemented via software. Such updates are accomplished via the system’s USB interface and do not require systems to be returned to the factory for service.
MagPro systems are additionally FDA cleared for use as magnetic stimulators for the stimulation of peripheral nerve for diagnostic studies. For those interested in changing the properties of the system for applications related to stimulation of peripheral nerve for diagnostic purposes, many additional components including coils can be added fitted to the core of the MagVita system (the MagPro stimulator). If the MagVita system is granted future expanded indications for use by the FDA, it is highly likely that the modular nature of the MagVita system will support upgrade of systems to support future applications.
Why should I choose MagVita?
- MagVenture is the only company to offer an FDA cleared 3 min TBS protocol allowing you to treat up to 6 patients per hour
- MagVenture offers a flat purchase with no pay-per-use fee
- Leasing option via third party medical device leasing companies.
- Easy-to-use system: 1) Position patient 2) set the pre-defined treatment protocol and 3) start treatment.
- High power stimulation and highly efficient liquid cooling which ensures a very high patient throughput
- Safe and effective
- Lowest intense acoustic noise signature (clicking) when compared to other FDA cleared TMS systems
- Onsite training included with all MagVita TMS system purchases. A visit with current MagVita TMS Therapy reference providers is also possible.
- Extended warranty, loaner service and service contracts available.
- Upgradable for possible future FDA cleared depression treatment protocols
Does MagVenture plan to participate in clinical trials?
A number of multisite clinical trials using MagPro systems are currently underway. These studies are not sponsored by MagVenture, but by independent medical research organizations that have opted to use the MagVenture system for their own research. MagVenture presently has no plans to sponsor clinical trials in the USA for expanded indications for the use of MagPro stimulator systems.
Is it possible to visit MagVita TMS treatment providers?
MagVenture has a number of MagVita TMS Therapy System providers in various regions of the USA that have expressed being amenable to speaking with prospective customers. Often MagVenture can put prospective customers in direct contact with existing providers to facilitate unbiased exchange of information on a peer to peer basis. Site visits with existing users and/ or teleconference meetings are also possibilities by which prospective users can learn from peers who have experience using the MagVita system.