Mr. Robin Salmansohn
08-20-2003, 12:56 PM
I just spoke to Cyberonics on the phone. Two weeks ago, the FDA approved the model 102R pulse generator.
The first model generator that Cyberonics had released was the model 100. Later they released the model 101, a small, thinner, lighter weight model pulse generator, with a longer battery life than the model 100 (From 3-5 years for the 100, to 5-7 years for the 101, average settings). (For some reason, the first unit installed has a shorter battery life than later units). Shortly thereafter, Cyberonics released a new model, the 102. The 102 has some design changes. First it is thinner and smaller than the 101, and it has a longer battery life than the 101 (7-10 years for the 102). It also has a different programming 'wand'. The 100 and the 101 require that a box with a cable (called a wand) be held over the pateint's chest impant and that the wand must be plugged in to a computer (such as a laptop) (with it's own software). The model 102 uses a self-contained programming wand, and does not require a computer. The 102 had also been designed so that the wires from the electrodes be inserted in to the generator using a single plug (much like an earphone plug). The model 100, and 101's elecrodes, cannot be used with the 102 (the 100 and the 101 use two seperate wires). This meant that anyone wishing to upgrade would have to also have their electrodes replaced. The model 102R (R stands for 'Replacement', I am told) is the same 102 generator but it can accomodate the older 2 discrete 100 and 101 electrode wires. This means less surgery for pateints seeking to upgrade.
In addition, Cyberonics has announced that they have completed a newer study and are seeking approval from the FDA for use in treating depression.
The first model generator that Cyberonics had released was the model 100. Later they released the model 101, a small, thinner, lighter weight model pulse generator, with a longer battery life than the model 100 (From 3-5 years for the 100, to 5-7 years for the 101, average settings). (For some reason, the first unit installed has a shorter battery life than later units). Shortly thereafter, Cyberonics released a new model, the 102. The 102 has some design changes. First it is thinner and smaller than the 101, and it has a longer battery life than the 101 (7-10 years for the 102). It also has a different programming 'wand'. The 100 and the 101 require that a box with a cable (called a wand) be held over the pateint's chest impant and that the wand must be plugged in to a computer (such as a laptop) (with it's own software). The model 102 uses a self-contained programming wand, and does not require a computer. The 102 had also been designed so that the wires from the electrodes be inserted in to the generator using a single plug (much like an earphone plug). The model 100, and 101's elecrodes, cannot be used with the 102 (the 100 and the 101 use two seperate wires). This meant that anyone wishing to upgrade would have to also have their electrodes replaced. The model 102R (R stands for 'Replacement', I am told) is the same 102 generator but it can accomodate the older 2 discrete 100 and 101 electrode wires. This means less surgery for pateints seeking to upgrade.
In addition, Cyberonics has announced that they have completed a newer study and are seeking approval from the FDA for use in treating depression.