Search Results

For Adults: Horizon 3.0 TMS Therapy Systems are indicated for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). For Adolescents: Horizon 3.0 TMS Therapy Systems are indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21).

The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. ("TMS"). The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of - Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode - as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). - as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15--21) The Horizon® 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient settings, including physicians' offices, clinics, and hospitals. The Horizon® 3.0 TMS Therapy System configurations are an integrated system consisting of a combination of hardware, software, and accessories. The Horizon® 3.0 TMS Therapy System is offered in three configurations: - Horizon 3.0 Inspire (Cleared under K241518). - - Horizon 3.0 (Cleared under K232235, K223154, K222171 and K211389), - - Horizon 3.0 with StimGuide Pro (Cleared under K232235). The three tiers of system offer equivalent safety and effectiveness with the main purpose allowing for physician offices, clinics and hospitals to choose a configuration that suits the organizational needs and provide different entry levels to promote the accessibility of TMS Therapy Treatments to health delivery organizations. All three configurations have identical intended use/indications for use, common specifications, equivalent performance and equivalent composition. All three devices share equivalent technological characteristics and principles of operation. All configurations are composed from the following main components: - Stimulating Unit & Power Supply - - User Interface - Applicating Coil for Motor Threshold - - -Applicating Coil for Treatment Delivery - -System and Applicating Coil Cart and Holding Arm The Horizon 3.0 with StimGuide Pro specifically includes a stereotactic infrared tracking system for aiding coil positioning.

Horizon® 3.0 TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. ("TMS"). The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). The Horizon® 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings, including physicians' offices, clinics, and hospitals. The Horizon® 3.0 TMS Therapy System configurations are an integrated system consisting of a combination of hardware, software, and configurations: - Horizon 3.0 Inspire (Subject of this submission). - Horizon 3.0 (Previously cleared under K232235, K223154, K222171 and K211389). - Horizon 3.0 with StimGuide Pro (Cleared under K232235). All three configurations, including the subject Horizon 3.0 Inspire configuration, have identical intended use/indications for use, common specifications, equivalent performance and equivalent composition. All three devices share equivalent technological characteristics and principles of operation. All configurations are composed from the following main components: - Stimulating Unit & Power Supply - User Interface - Applicating Coil for Motor Threshold - Applicating Coil for Treatment Delivery - System and Applicating Coil Cart and Holding Arm The Horizon 3.0 with StimGuide Pro specifically includes a stereotactic infrared tracking system for aiding coil positioning.

The Rapid2 Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The Rapid Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. The Rapid" Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from antidepressant medication in the current episode. The Rapid-Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient settings, including physicians' offices, clinics, and hospitals. The Rapid Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.