Breathing Pacemakers
Provide a far lower cost of care and a much higher quality of life for ventilator dependent patients with quadriplegia, central sleep apnea, and diaphragm paralysis.
The Mark IV Breathing Pacemaker System is a phrenic nerve stimulator, also called a diaphragm pacemaker. It consists of surgically implanted receivers and electrodes mated to an external transmitter by antennas worn over the implanted receivers.
Phrenic pacing provides ventilatory support for patients with chronic respiratory insufficiency whose diaphragm, lungs, and phrenic nerves have residual function. Diagnoses include, but are not limited to:
• Quadriplegia, complete or incomplete
• Congenital Central Hypoventilation Syndrome (CCHS)
• Diaphragm paralysis, known or unknown etiology
• Primary alveolar hypoventilation
• Central sleep apnea
• Brainstem stroke
• Brain injury or tumor
• Arnold-Chiari malformation
The Mark IV Breathing Pacemaker System is the only device of its kind to have full premarket approval by the US FDA and qualify for the CE Mark under the European Active Implantable Medical Device Directive. These devices are approved by the Center for Medicare & Medicaid Services (formerly HFCA) for Medicare reimbursement and by most other private and government insurance plans throughout the world.
Federal law (USA) restricts this device to sale by or on the order of a physician.
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