Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p115
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 115/696)
Character Range: 2690362–2712065

104 is an implantable, dual pin lead compatible and multiprogrammable pulse generator that delivers electrical signals to the vagus nerve.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       one size only                                                                                                                                                                                                                                                                                                                                                                     $11,435.00
SA174                                                                                           VNS Therapy Pulse/Pulse Duo                                                                                                               Model 102/102R Generator                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          One size only                                                                                                                                                                                                                                                                                                                                                                     $11,435.00
SA185                                                                                           VNS Therapy Demipulse Generator 103                                                                                                       The generator is an implantable multiprogrammable pulse generator that delivers electrical signals to the vagus nerve. The pulse generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the pulse generator to the vagus nerve                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Lead Receptacle 0.126 in (3.2 mm)                                                                                                                                                                                                                                                                                                                                                 $11,435.00
                                                                                                                                                                                                                                          by the lead. The VNS Therapy System is indicated for use as an adjunctive                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Dimension 1.8 in x 1.3 in x 0.27 in (45 mm x 32 mm x 6.9mm)
                                                                                                                                                                                                                                          therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Weight 0.56 oz (16 g)

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            The 103 is smaller than previous devices, and fits in the palm of your hand and may be used in pediatric patients
SA186                                                                                           Aspire SR Pulse Generator Model 106                                                                                                       The 106 VNS therapy system is indicated for use as a adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications. Model 106 has the added feature of Autostim. In patients who experience Ictal Tachycardia which is defined as an increase in heart rate during a seizure specifically from baseline to a rate greater than 100 BPM and is at least 55% increase or 35 BPM increase from baseline delivering a therapeutic stimulation automatically delivered on detection of a physiological signal indicative of the onset of a seizure.                                                                                                                                                                                                                                                                                                                                     Lead receptacle -  0.126 in (3.2 mm) nominal                                                                                                                                                                                                                                                                                                                                      $11,435.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Dimensions -2.0 in x 2.0 in x 0.27 in (52 mm x 52 mm x 6.9 mm)
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Weight- 0.88 oz (25 g)

  04.07.01.02 - Lead
     Livanova Australia Pty Limited
SA175                                                                                           VNS Therapy Lead                                                                                                                          Model 302                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         One size only                                                                                                                                                                                                                                                                                                                                                                     $3,069.00
SA191                                                                                           LivaNova PerenniaDURA Lead Model 303 for Vagus Nerve Stimulation                                                                          The PerenniaDURA Lead Model 303 is a silicone insulated implantable patient lead, delivering the electrical signal from the VNS Generators to the left vagus nerve.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Available in two sizes: Model 303.20 (2.0 millimeter inner diameter of helical coil) and Model 303.30 (3.0 millimeter inner diameter of helical coil).                                                                                                                                                                                                                            $3,069.00
SA187                                                                                           VNS Therapy PerenniaFLEX Model 304.2 & 304.3                                                                                              Model 304 lead is a silicone insulated implantable patient lead, delivering the electrical signal from the Pulse Generator to the Vagus Nerve.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Lead Body                                                                                                                                                                                                                                                                                                                                                                         $3,069.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Diameter : 2mm (.08 in)
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Insulation: Silicone
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Overall Length: 43cm