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The patient programmer is an external device that is about the size of a cell phone or PDA, and is used by the patient to activate the Inspire system before they go to sleep. The patient places the programmer over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation amplitude (within limits set by the physician). The patient programmer also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide confirmation of IPG status (Therapy ON/OFF and Battery Status). The patient programmer will only communicate with the Inspire system IPG
Inspire Medical Systems, Inc.
900-000-016
In Commercial Distribution
- 00855728005031 ()
3032
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3024 Inspire II IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously below the clavicle in the upper chest, and connects to the stimulation lead and sensing lead.
The IPG has multiple programmable parameters that can be adjusted for a particular patient. Adjustments may be made to the sensing circuits to vary the timing of stimulation pulses and to the stimulation circuits to adjust the energy and duration of stimulation pulses. These adjustments provide the ability to optimize the opening of the upper airway. Based on typical settings from the STAR pivotal trial the longevity of the IPG’s battery will average 10 years.
The Model 3024 IPG was originally developed by Medtronic and utilizes the same platform as Medtronic’s Itrel® 3 IPG which is FDA approved for other neurostimulation therapies. Figure 9 provides a photograph of the Model 3024 IPG.
Inspire Medical Systems, Inc.
900-003-015
In Commercial Distribution
- 00855728005024 ()
3024
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.
Inspire Medical Systems, Inc.
900-001-005
In Commercial Distribution
- 00855728005017 ()
4063
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration.
Inspire Medical Systems, Inc.
900-002-005
In Commercial Distribution
- 00855728005000 ()
4323
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Acellular dermal matrix
STELLEN MEDICAL, LLC
3102-2151
In Commercial Distribution
- 00855638007033 ()
- Width: 5 Centimeter
- Length: 10 Centimeter
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Acellular Dermal Matrix
STELLEN MEDICAL, LLC
3102-2147
In Commercial Distribution
- 00855638007026 ()
- Width: 4 Centimeter
- Length: 7 Centimeter
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Acellular Dermal Matrix
STELLEN MEDICAL, LLC
3102-2144
In Commercial Distribution
- 00855638007019 ()
- Width: 4 Centimeter
- Length: 4 Centimeter
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Acellular Dermal Matrix
STELLEN MEDICAL, LLC
3102-2125
In Commercial Distribution
- 00855638007002 ()
- Width: 2 Centimeter
- Length: 5 Centimeter
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Case.
Neuropace, Inc.
5107
In Commercial Distribution
- 00855547005434 ()
- 00855547005427 ()
- Brain-responsive electrical stimulation system
The Explant Kit package contains 2 Lead Caps and 1 Torque Driver.
Neuropace, Inc.
EX-01-K
In Commercial Distribution
- 00855547005410 ()
- Brain-responsive electrical stimulation system