Profile: Cyberonics Inc (CYBX.OQ)
5 Dec 2013
Cyberonics, Inc. (Cyberonics), incorporated in 1987, is a medical device company. The Company is engaged in the design, development, sales and marketing of implantable medical devices that provide a neuromodulation therapy, vagus nerve stimulation therapy (VNS Therapy), for the treatment of refractory epilepsy and treatment-resistant depression (TRD) and other device solutions for the management of epilepsy.VNS Therapy System includes an implantable pulse generator to provide stimulation to the vagus nerve; a lead that connects the generator to the vagus nerve; equipment to assist with implantation surgery; equipment to assist with setting the stimulation parameters for each patient; instruction manuals, and magnets to suspend or induce stimulation manually. The VNS Therapy pulse generator and lead are surgically implanted into patients generally during an outpatient procedure. The VNS Therapy System consists of a pulse generator, a bipolar lead, a programming wand and software and a tunneling tool.
The United States Food and Drug Administration (FDA) approved the Company's VNS Therapy System in July 1997 for use as an adjunctive therapy in epilepsy patients over 12 years of age for reducing the frequency of partial onset seizures that are refractory or resistant to antiepileptic drugs. Regulatory bodies in Canada, the European Economic Area, certain countries in Eastern Europe, Russia, South America, Africa, Australia and certain countries in Asia, including Japan, China and Taiwan, have approved the VNS Therapy System for the treatment of epilepsy, many without age restrictions or seizure-type limitations. In July 2005, the FDA approved the Company's VNS Therapy System for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a depressive episode and have not had an adequate response to four or more adequate anti-depressant treatments. Regulatory bodies in the European Economic Area, Canada and Israel have approved the Company's VNS Therapy System for the treatment of chronic or recurrent depression in patients who are in a treatment-resistant or treatment-intolerant depressive episode without age restrictions.
In February 2011, the Company announced FDA approval of its fifth generation generator, the AspireHC generator. In August 2011, the Company announced that the Company discovered a hardware-related design issue with the AspireHC Model 105 and AspireSR (Seizure Response) Model 106 generators. In December 2011, the FDA approved the Company's re-designed AspireHC generator, and the Company resumed its limited commercial release of the generator in the United States.
The pulse generator is an implantable, programmable signal generator designed to be coupled with the bipolar lead to deliver mild electrical pulses to the vagus nerve. The pulse generator is a battery-powered device. Before or upon depletion of the battery, the pulse generator may be removed and a new generator implanted in a short, outpatient procedure. The Model 102 (Pulse), Model 102R (Pulse Duo ), Model 103 (Demipulse), Model 104 (Demipulse Duo) and Model 105 (AspireHC), are the VNS Therapy pulse generators the Company offers and are similar in design and manufactures to a cardiac pacemaker.
The bipolar lead conducts the electrical signal from the pulse generator to the vagus nerve. The lead incorporates electrodes, which are self-sizing, minimizing mechanical trauma to the nerve. The lead's two electrodes and anchor tether wrap around the vagus nerve, and the connector end is tunneled subcutaneously to the upper chest area, where it attaches to the pulse generator. The Company offers three lead models in the United States. The leads are available in two inner spiral diameter sizes to ensure optimal electrode placement on different-sized nerves.
Programming Wand and Software
The Company's programming wand and software are used to interrogate the implanted pulse generator and to transmit programming information from a handheld computer to the pulse generator via an inductive coupling. Programming capabilities include modification of the pulse generator's programmable parameters (pulse width, amplitude and frequency and stimulation ON and OFF intervals) and storage and retrieval of telemetry data.
The tunneling tool is a single use, sterile, disposable surgical tool designed to be used during surgical placement of the bipolar lead. The tool is used for subcutaneous tunneling of the lead between the nerve site in the neck and the pulse generator site in the upper chest area.
The accessory pack includes two resistor assemblies used to test the function of the device prior to implantation, the bipolar lead tie-downs and one hex screwdriver. The patient kit includes two magnets, one watch-style and one pager-style.
The Company competes with Medtronic, Inc., NeuroSigma Inc. and CerboMed GmbH.
The Cyberonics Building
100 CYBERONICS BLVD
HOUSTON TX 77058