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218-9332.
MRI WITH THE VNS THERAPY SYSTEM MRI with the VNS Therapy® System 4 — 26-0010-0300/3 (Worldwide)1INTRODUCTION Note: For a definition of VNS and MRI terms, see the Glossary, which can be found at www.livanova.com. MR Unsafe devices include the programming wand, computer, and patient magnet. These devices must not be brought into the MR scanner room. 1.1 MRConditional Device
WELCOME TO VNS THERAPY.COM FOR HEALTH CARE PROFESSIONALS The VNS Therapy™ System has been implanted in more than 30,000 epilepsy patients. Back-up of all implanted components are needed at all surgeries. VNS Therapy Pulse Generators. The Pulse Generator is an implantable, programmable signal generator that delivers a precise pattern of stimulation to the left vagus nerve. Model 102 Generator. MANUALS « VNS THERAPY « HEALTHCARE PROFESSIONALS, ON VNS 1.34. VNS Therapy System Epilepsy Physician's Manual (US) 4.76. VNS Therapy System_Depression Physician's Manual (US) 5.22. VNS Therapy System_Physician’s Manual Addendum – Cyberonics Pulse Generators. 0.07. VNS Therapy System_Pre-Surgical Evaluation Tool -2-Position.0.22.
FIND A DOCTOR NEAR YOU « PATIENTS & FAMILIES, ON VNS Find a Doctor Near You « Patients & Families, on VNS Therapy | Cyberonics US. There are 3 ways to search for a Physician: ZIP CODE SEARCH. ENTER ZIP CODE. I WANT TO SEE ALL PHYSICIANS THAT ARE APPROXIMATELY. This field is required. 50 100 150 VNS THERAPY DEMIPULSE GENERATOR AND VNS THERAPY DEMIPULSE Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53 PHYSICIAN’S MANUAL Physician’s Manual 8 — 26-0009-4400/3 (US)1.5 Communication Signals Note: See the physician's manual for the VNS Therapy pulse generators for a complete description of the pulse generator, its indications for use, and its operation. Note: See the physician’s manual for the programming wand for a description of the programming wand. Rapid, ascending musical tones and a screen message in VNS THERAPY® SYSTEM EPILEPSY PHYSICIAN’S MANUAL www.livanova.com Rx Only VNS Therapy® System Epilepsy Physician’s Manual Pulse™ Generator—Model 102 Pulse Duo™ Generator—Model 102R Demipulse® Generator—Model 103 PATIENT’S GUIDE FOR EPILEPSY This Patient’s Guide is a supplement to the physician’s manuals. It is not intended to substitute for advice from your doctor. For a complete discussion of indications for use, contraindications, VNS THERAPY LEAD MODEL 302 VNS THERAPY PERENNIA LEAD MODEL … Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53 WELCOME TO VNS THERAPY.COM FOR HEALTH CARE PROFESSIONALS If you have any questions or require additional information regarding the operation or implantation of the VNS Therapy System, any of its accessories, or vagus nerve stimulation, please contact: Clinical Technical Services. Cyberonics, Inc. Phone: (866) 882-8804. Fax: (281)218-9332.
MRI WITH THE VNS THERAPY SYSTEM MRI with the VNS Therapy® System 4 — 26-0010-0300/3 (Worldwide)1INTRODUCTION Note: For a definition of VNS and MRI terms, see the Glossary, which can be found at www.livanova.com. MR Unsafe devices include the programming wand, computer, and patient magnet. These devices must not be brought into the MR scanner room. 1.1 MRConditional Device
WELCOME TO VNS THERAPY.COM FOR HEALTH CARE PROFESSIONALS The VNS Therapy™ System has been implanted in more than 30,000 epilepsy patients. Back-up of all implanted components are needed at all surgeries. VNS Therapy Pulse Generators. The Pulse Generator is an implantable, programmable signal generator that delivers a precise pattern of stimulation to the left vagus nerve. Model 102 Generator. MANUALS « VNS THERAPY « HEALTHCARE PROFESSIONALS, ON VNS 1.34. VNS Therapy System Epilepsy Physician's Manual (US) 4.76. VNS Therapy System_Depression Physician's Manual (US) 5.22. VNS Therapy System_Physician’s Manual Addendum – Cyberonics Pulse Generators. 0.07. VNS Therapy System_Pre-Surgical Evaluation Tool -2-Position.0.22.
FIND A DOCTOR NEAR YOU « PATIENTS & FAMILIES, ON VNS Find a Doctor Near You « Patients & Families, on VNS Therapy | Cyberonics US. There are 3 ways to search for a Physician: ZIP CODE SEARCH. ENTER ZIP CODE. I WANT TO SEE ALL PHYSICIANS THAT ARE APPROXIMATELY. This field is required. 50 100 150 VNS THERAPY DEMIPULSE GENERATOR AND VNS THERAPY DEMIPULSE Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53 PHYSICIAN’S MANUAL Physician’s Manual 8 — 26-0009-4400/3 (US)1.5 Communication Signals Note: See the physician's manual for the VNS Therapy pulse generators for a complete description of the pulse generator, its indications for use, and its operation. Note: See the physician’s manual for the programming wand for a description of the programming wand. Rapid, ascending musical tones and a screen message in VNS THERAPY® SYSTEM EPILEPSY PHYSICIAN’S MANUAL www.livanova.com Rx Only VNS Therapy® System Epilepsy Physician’s Manual Pulse™ Generator—Model 102 Pulse Duo™ Generator—Model 102R Demipulse® Generator—Model 103 PATIENT’S GUIDE FOR EPILEPSY This Patient’s Guide is a supplement to the physician’s manuals. It is not intended to substitute for advice from your doctor. For a complete discussion of indications for use, contraindications, VNS THERAPY LEAD MODEL 302 VNS THERAPY PERENNIA LEAD MODEL … Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53 MANUALS « VNS THERAPY « HEALTHCARE PROFESSIONALS, ON VNS 1.34. VNS Therapy System Epilepsy Physician's Manual (US) 4.76. VNS Therapy System_Depression Physician's Manual (US) 5.22. VNS Therapy System_Physician’s Manual Addendum – Cyberonics Pulse Generators. 0.07. VNS Therapy System_Pre-Surgical Evaluation Tool -2-Position.0.22.
WELCOME TO VNS THERAPY.COM FOR HEALTH CARE PROFESSIONALS It is the provider's responsibility to file claims with appropriate ICD-9, CPT-4, HCPCS, revenue, and/or APC codes along with charges for the services provided. Please contact your local payer if you have questions regarding appropriate coding guidelines. Cyberonics offers a VNS Therapy Reimbursement Department at. 1-888-508-8082. VNS THERAPY LEAD MODEL 302 VNS THERAPY PERENNIA LEAD MODEL … Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53 LIVANOVA TUNNELER MODEL 402 LivaNova® Tunneler Model 402 26-0007-6300/2 (U.S.) — 3 of 4Do not use the Tunneler if the following occurs: The outer or inner package has been pierced or altered, because this could have rendered it nonsterile. The expiration (use-before) date has passed, because this FIND A DOCTOR NEAR YOU « PATIENTS & FAMILIES, ON VNS There are 3 ways to search for a Physician: Zip Code Search: Enter Zip Code: I want to see all Physicians that are approximately 50 100 COMMON CODING OPTIONS FOR VNS THERAPY (VAGUS NERVE COMMON CODING OPTIONS FOR VNS THERAPY (VAGUS NERVE STIMULATION) ICD-9-CM (DSM-IV)—DIAGNOSIS CODES Depression 296.2x* Major depressive disorder, single episodeRADIOAPPROVALS
RadioApprovals 1.4. WirelessTechnologyInformation 1.4.1. Model2000€ProgrammingWand FrequencyofOperation 2402-2480MHz 0.082-0.089MHz TransmitPower 0.01W 27.17dBuV/mat300m EXECUTIVE SUMMARY AND DISCUSSION OF THE VAGUS NERVE Page 3 of 54 1.2. Unmet Medical Needs in the Management of TRD Depression is a very common disorder that is most often chronic or recurrent in nature. VNS THERAPY FREQUENTLY ASKED QUESTIONS September 2007 Volume 3, Issue 3 “Eleven years ago, my life was great,” said 45-year-old John, with a caring, supportive wife and a rewarding career in finance. However, in 1996 IMPORTANT SAFETY ALERT Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53 WELCOME TO VNS THERAPY.COM FOR HEALTH CARE PROFESSIONALS If you have any questions or require additional information regarding the operation or implantation of the VNS Therapy System, any of its accessories, or vagus nerve stimulation, please contact: Clinical Technical Services. Cyberonics, Inc. Phone: (866) 882-8804. Fax: (281)218-9332.
MRI WITH THE VNS THERAPY SYSTEM MRI with the VNS Therapy® System 4 — 26-0010-0300/3 (Worldwide)1INTRODUCTION Note: For a definition of VNS and MRI terms, see the Glossary, which can be found at www.livanova.com. MR Unsafe devices include the programming wand, computer, and patient magnet. These devices must not be brought into the MR scanner room. 1.1 MRConditional Device
WELCOME TO VNS THERAPY.COM FOR HEALTH CARE PROFESSIONALS The VNS Therapy™ System has been implanted in more than 30,000 epilepsy patients. Back-up of all implanted components are needed at all surgeries. VNS Therapy Pulse Generators. The Pulse Generator is an implantable, programmable signal generator that delivers a precise pattern of stimulation to the left vagus nerve. Model 102 Generator. MANUALS « VNS THERAPY « HEALTHCARE PROFESSIONALS, ON VNS 1.34. VNS Therapy System Epilepsy Physician's Manual (US) 4.76. VNS Therapy System_Depression Physician's Manual (US) 5.22. VNS Therapy System_Physician’s Manual Addendum – Cyberonics Pulse Generators. 0.07. VNS Therapy System_Pre-Surgical Evaluation Tool -2-Position.0.22.
FIND A DOCTOR NEAR YOU « PATIENTS & FAMILIES, ON VNS Find a Doctor Near You « Patients & Families, on VNS Therapy | Cyberonics US. There are 3 ways to search for a Physician: ZIP CODE SEARCH. ENTER ZIP CODE. I WANT TO SEE ALL PHYSICIANS THAT ARE APPROXIMATELY. This field is required. 50 100 150 VNS THERAPY DEMIPULSE GENERATOR AND VNS THERAPY DEMIPULSE Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53 PHYSICIAN’S MANUAL Physician’s Manual 8 — 26-0009-4400/3 (US)1.5 Communication Signals Note: See the physician's manual for the VNS Therapy pulse generators for a complete description of the pulse generator, its indications for use, and its operation. Note: See the physician’s manual for the programming wand for a description of the programming wand. Rapid, ascending musical tones and a screen message in VNS THERAPY® SYSTEM EPILEPSY PHYSICIAN’S MANUAL www.livanova.com Rx Only VNS Therapy® System Epilepsy Physician’s Manual Pulse™ Generator—Model 102 Pulse Duo™ Generator—Model 102R Demipulse® Generator—Model 103 PATIENT’S GUIDE FOR EPILEPSY This Patient’s Guide is a supplement to the physician’s manuals. It is not intended to substitute for advice from your doctor. For a complete discussion of indications for use, contraindications, VNS THERAPY LEAD MODEL 302 VNS THERAPY PERENNIA LEAD MODEL … Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53 WELCOME TO VNS THERAPY.COM FOR HEALTH CARE PROFESSIONALS If you have any questions or require additional information regarding the operation or implantation of the VNS Therapy System, any of its accessories, or vagus nerve stimulation, please contact: Clinical Technical Services. Cyberonics, Inc. Phone: (866) 882-8804. Fax: (281)218-9332.
MRI WITH THE VNS THERAPY SYSTEM MRI with the VNS Therapy® System 4 — 26-0010-0300/3 (Worldwide)1INTRODUCTION Note: For a definition of VNS and MRI terms, see the Glossary, which can be found at www.livanova.com. MR Unsafe devices include the programming wand, computer, and patient magnet. These devices must not be brought into the MR scanner room. 1.1 MRConditional Device
WELCOME TO VNS THERAPY.COM FOR HEALTH CARE PROFESSIONALS The VNS Therapy™ System has been implanted in more than 30,000 epilepsy patients. Back-up of all implanted components are needed at all surgeries. VNS Therapy Pulse Generators. The Pulse Generator is an implantable, programmable signal generator that delivers a precise pattern of stimulation to the left vagus nerve. Model 102 Generator. MANUALS « VNS THERAPY « HEALTHCARE PROFESSIONALS, ON VNS 1.34. VNS Therapy System Epilepsy Physician's Manual (US) 4.76. VNS Therapy System_Depression Physician's Manual (US) 5.22. VNS Therapy System_Physician’s Manual Addendum – Cyberonics Pulse Generators. 0.07. VNS Therapy System_Pre-Surgical Evaluation Tool -2-Position.0.22.
FIND A DOCTOR NEAR YOU « PATIENTS & FAMILIES, ON VNS Find a Doctor Near You « Patients & Families, on VNS Therapy | Cyberonics US. There are 3 ways to search for a Physician: ZIP CODE SEARCH. ENTER ZIP CODE. I WANT TO SEE ALL PHYSICIANS THAT ARE APPROXIMATELY. This field is required. 50 100 150 VNS THERAPY DEMIPULSE GENERATOR AND VNS THERAPY DEMIPULSE Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53 PHYSICIAN’S MANUAL Physician’s Manual 8 — 26-0009-4400/3 (US)1.5 Communication Signals Note: See the physician's manual for the VNS Therapy pulse generators for a complete description of the pulse generator, its indications for use, and its operation. Note: See the physician’s manual for the programming wand for a description of the programming wand. Rapid, ascending musical tones and a screen message in VNS THERAPY® SYSTEM EPILEPSY PHYSICIAN’S MANUAL www.livanova.com Rx Only VNS Therapy® System Epilepsy Physician’s Manual Pulse™ Generator—Model 102 Pulse Duo™ Generator—Model 102R Demipulse® Generator—Model 103 PATIENT’S GUIDE FOR EPILEPSY This Patient’s Guide is a supplement to the physician’s manuals. It is not intended to substitute for advice from your doctor. For a complete discussion of indications for use, contraindications, VNS THERAPY LEAD MODEL 302 VNS THERAPY PERENNIA LEAD MODEL … Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53 MANUALS « VNS THERAPY « HEALTHCARE PROFESSIONALS, ON VNS 1.34. VNS Therapy System Epilepsy Physician's Manual (US) 4.76. VNS Therapy System_Depression Physician's Manual (US) 5.22. VNS Therapy System_Physician’s Manual Addendum – Cyberonics Pulse Generators. 0.07. VNS Therapy System_Pre-Surgical Evaluation Tool -2-Position.0.22.
WELCOME TO VNS THERAPY.COM FOR HEALTH CARE PROFESSIONALS It is the provider's responsibility to file claims with appropriate ICD-9, CPT-4, HCPCS, revenue, and/or APC codes along with charges for the services provided. Please contact your local payer if you have questions regarding appropriate coding guidelines. Cyberonics offers a VNS Therapy Reimbursement Department at. 1-888-508-8082. VNS THERAPY LEAD MODEL 302 VNS THERAPY PERENNIA LEAD MODEL … Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53 LIVANOVA TUNNELER MODEL 402 LivaNova® Tunneler Model 402 26-0007-6300/2 (U.S.) — 3 of 4Do not use the Tunneler if the following occurs: The outer or inner package has been pierced or altered, because this could have rendered it nonsterile. The expiration (use-before) date has passed, because this FIND A DOCTOR NEAR YOU « PATIENTS & FAMILIES, ON VNS There are 3 ways to search for a Physician: Zip Code Search: Enter Zip Code: I want to see all Physicians that are approximately 50 100 COMMON CODING OPTIONS FOR VNS THERAPY (VAGUS NERVE COMMON CODING OPTIONS FOR VNS THERAPY (VAGUS NERVE STIMULATION) ICD-9-CM (DSM-IV)—DIAGNOSIS CODES Depression 296.2x* Major depressive disorder, single episodeRADIOAPPROVALS
RadioApprovals 1.4. WirelessTechnologyInformation 1.4.1. Model2000€ProgrammingWand FrequencyofOperation 2402-2480MHz 0.082-0.089MHz TransmitPower 0.01W 27.17dBuV/mat300m EXECUTIVE SUMMARY AND DISCUSSION OF THE VAGUS NERVE Page 3 of 54 1.2. Unmet Medical Needs in the Management of TRD Depression is a very common disorder that is most often chronic or recurrent in nature. VNS THERAPY FREQUENTLY ASKED QUESTIONS September 2007 Volume 3, Issue 3 “Eleven years ago, my life was great,” said 45-year-old John, with a caring, supportive wife and a rewarding career in finance. However, in 1996 IMPORTANT SAFETY ALERT Page 1 of 2 100 Cyberonics Blvd • Houston, TX 77058 • Tel: (800) 332-1375 • Fax: (281) 218-9332 Belgicastraat 9 • 1930 Zaventem • Belgium • Tel: 32 2 720 95 93 • Fax: 32 2 720 60 53Choose language
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VNS Therapy is the #1 prescribed device for treating the seizures medications can't. It has been used by over 100,000 people, including more than 33,000 children worldwide. VNS THERAPY WORKS TO PROVIDE FEWER SEIZURES, SHORTER SEIZURES AND AN IMPROVED RECOVERY AFTER SEIZURES. -------------------------MANUALS
CONTACT US
INVESTOR RELATIONS
investor.relations@livanova.com corporate.communications@livanova.comCUSTOMER SUPPORT
1-866-332-1375
(If you are an implanted patient and need a replacement VNS Therapy Patient Emergency Information Card, please contact Customer Support) CLINICAL TECHNICAL SERVICESUS: +1-866-882-8804
INTERNATIONAL: +32-2-790-27-73 (Physicians of implanted patients can contact Clinical Technical Services regarding technical concerns) Patients needing additional magnets should contact their physicians. Patients and caregivers of implanted patients should contact their physicians with technical concerns. Epilepsy (Non-US)—The VNS Therapy System is indicated for use as an 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 AspireSR™ (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Epilepsy (US)--The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications.Commonly reported side effects are hoarseness, shortness of breath, sore throat and coughing. Side effects typically occur during stimulation and decrease over time. Download the appropriate country product information above for important safety information. Commonly reported side effects are hoarseness, shortness of breath, sore throat and coughing. Side effects typically occur during stimulation and decrease over time. Download the appropriate country product information above for important safety information. -------------------------LIVANOVA PLC
Mfg by LivaNova USA
100 Cyberonics Boulevard Houston, Texas 77058 Tel: +1.800.332.1375 Fax: +1.281.218.9332UK: 0800 0461355
EU: +32 2 790 27 73www.LivaNova.com
LivaNova Belgium NV
Ikaroslaan 83
1930 Zaventem
Belgium
Tel: +32.2.720.95.93 Fax: +32.2.720.60.53Details
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