Vagus Nerve Stimulation (VNS(TM)) Found to Effectively Reduce The Need for Antiepileptic Drugs in Refractory Epilepsy Patients, Study Says

Study Patients Also Achieve Decrease in Seizure Occurrence With VNS



Apr 11, 2001, 01:00 ET from Cyberonics, Inc.

    HOUSTON, April 11 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq:   CYBX) today
 announced that a new study has found that VNS was effective in reducing the
 need for antiepileptic drugs (AEDs) in patients with refractory epilepsy.  The
 study was performed by researchers at Tampa General Hospital Epilepsy Center
 and the University of South Florida College of Medicine, and the results are
 published in Neurology (February 27, 2001, Volume 56, Issue 4).
     The prospective study followed 21 epilepsy patients treated with VNS for
 13.2 months.  The mean number of AEDs taken by the patient population was 2.8.
 By the end of the study period, both AEDs and/or AED doses were reduced in
 15 of 21 patients without compromising seizure control.  AED reduction was
 possible in nine of the 21 patients, with an average reduction of 0.43 AEDs
 per patient.  Almost half of the patients were able to reduce the number of
 antiepileptic drugs or doses taken compared to an increase in the number of
 drugs seen in a case-matched control group.  One third of patients were able
 to discontinue the use of psychotropic drugs.  Seizures were reduced in 17 of
 21 (76.2%) patients; 19% had greater than a 75% reduction; 23.8% had a 50% to
 75% reduction; and 43% had greater than a 50% reduction.  Mood improvement was
 reported in 14 of 21 (66.7%) patients, and 17 of 21 (80.9%) patients rated
 overall quality of life following VNS as better or much better compared to
 pre-implantation.
     "The goal of epilepsy management strives for both the absence of seizures
 and side effects," said Dr. William O. Tatum IV, clinical associate professor
 at the University of South Florida and director of the Tampa General Hospital
 Outpatient Epilepsy Clinic.  "Other recent studies have shown that 75% of
 patients are likely to discontinue a selected drug therapy due to the
 potential for negative side effects.  These undesirable side effects that
 accompany many antiepileptic drugs may impede patients' overall therapy
 despite their effect on seizure control.  Our results suggest that VNS may be
 a treatment that allows for fewer necessary AEDs at lower effective doses.
 Not only were medications reduced, but over 76% of the patients saw a
 reduction in their seizures with VNS."
     VNS therapy is delivered by the Cyberonics NeuroCybernetic Prosthesis
 (NCP(R)) System, an implantable medical device similar to a cardiac pacemaker.
 A stopwatch-sized generator is implanted in the left chest and a nerve
 stimulation electrode is attached to the vagus nerve in the neck in a one to
 two hour procedure typically done on an outpatient basis.  Using an external
 programmer, the physician can set or reset the stimulation parameters of the
 device.  The System delivers preprogrammed intermittent electrical pulses to
 the vagus nerve 24 hours a day.  The first human implant of the system
 occurred in 1988 in a patient with epilepsy.  On July 16, 1997, the FDA
 approved VNS therapy with the Cyberonics NCP System as an adjunctive therapy
 for the treatment of medically refractory partial onset seizures in adults and
 adolescents over 12 years of age.  To date, more than 10,000 epilepsy patients
 in 24 countries have accumulated over 14,000 patient years of experience using
 Vagus Nerve Stimulation.  The most common side effects of VNS therapy seen in
 patients with refractory epilepsy are voice alteration, shortness of breath,
 discomfort and coughing, all of which occur during the actual stimulation.
 The NCP System is not authorized for use in the treatment of depression,
 obesity, Alzheimer's Disease or anxiety disorders and is in the early stages
 of investigation for these uses.
     Cyberonics, Inc. (www.cyberonics.com) was founded in 1987 to design,
 develop and market medical devices for the treatment of epilepsy and other
 debilitating disorders using a unique therapy, vagus nerve stimulation.  The
 Company's initial target market is epilepsy, the world's second most prevalent
 neurological disorder, which is characterized by recurrent seizures.  VNS with
 the Cyberonics NeuroCybernetic Prosthesis (NCP(R)) System was approved by the
 FDA on July 16, 1997 for use as an adjunctive therapy in reducing the
 frequency of seizures in adults and adolescents over 12 years of age with
 medically refractory partial onset seizures.  In addition to the U.S., the NCP
 System is currently approved for sale as a treatment for epilepsy in all the
 member countries of the European Union, Canada, Australia and other markets.
 VNS delivered by the NCP System is at various levels of investigational
 clinical study as a potential treatment for depression, obesity and
 Alzheimer's disease.  In March 2001, Cyberonics received CE Mark Approval to
 sell VNS in the member countries of the European Union as a treatment for
 patients with treatment resistant or recurrent depression.
     This press release contains forward-looking statements within the meaning
 of Section 27A of the Securities Act of 1933, as amended and Section 21E of
 the Securities Exchange Act of 1934, as amended.  Such forward-looking
 statements include statements concerning:  maintaining and obtaining
 appropriate regulatory approvals; transitioning VNS therapy from a
 revolutionary treatment to a standard of care in epilepsy; developing VNS as a
 treatment for depression, Alzheimer's Disease, obesity and other indications;
 the timing and outcome of clinical studies; improving our productivity and
 efficiencies; increasing our sales and achieving profitability.  These
 predications are based upon information presently available to us and
 assumptions that we believe to be reasonable.  We are not assuming any duty to
 update this information should those facts change or should we no longer
 believe the assumptions to be reasonable.  Our actual results may differ
 materially.  Important factors that may cause actual results to differ
 include: ongoing safety and efficacy of VNS with the Cyberonics NCP System;
 the overall rate of demand for the Company's products; the Company's ability
 to hire, train and retain key personnel; the Company's ability to maintain all
 appropriate regulatory approvals; the Company's ability to develop and
 maintain adequate manufacturing capacities and sources of supply; the timing
 and results of future clinical studies; and the amount of timing of
 expenditures related to those and other activities; and management's ability
 to accurately forecast future events.  For further discussion of these and
 other important factors that could affect the Company's activities and
 results, please refer to the Company's Annual Report on Form 10-K for the year
 ended June 30, 2000, and the Company's Quarterly Report on Form 10Q for the
 three months ended September 30, 2000 and December 31, 2000.
     NCP is a registered trademark of Cyberonics, Inc.  VNS is a trademark of
 Cyberonics, Inc.
 
 

SOURCE Cyberonics, Inc.
    HOUSTON, April 11 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq:   CYBX) today
 announced that a new study has found that VNS was effective in reducing the
 need for antiepileptic drugs (AEDs) in patients with refractory epilepsy.  The
 study was performed by researchers at Tampa General Hospital Epilepsy Center
 and the University of South Florida College of Medicine, and the results are
 published in Neurology (February 27, 2001, Volume 56, Issue 4).
     The prospective study followed 21 epilepsy patients treated with VNS for
 13.2 months.  The mean number of AEDs taken by the patient population was 2.8.
 By the end of the study period, both AEDs and/or AED doses were reduced in
 15 of 21 patients without compromising seizure control.  AED reduction was
 possible in nine of the 21 patients, with an average reduction of 0.43 AEDs
 per patient.  Almost half of the patients were able to reduce the number of
 antiepileptic drugs or doses taken compared to an increase in the number of
 drugs seen in a case-matched control group.  One third of patients were able
 to discontinue the use of psychotropic drugs.  Seizures were reduced in 17 of
 21 (76.2%) patients; 19% had greater than a 75% reduction; 23.8% had a 50% to
 75% reduction; and 43% had greater than a 50% reduction.  Mood improvement was
 reported in 14 of 21 (66.7%) patients, and 17 of 21 (80.9%) patients rated
 overall quality of life following VNS as better or much better compared to
 pre-implantation.
     "The goal of epilepsy management strives for both the absence of seizures
 and side effects," said Dr. William O. Tatum IV, clinical associate professor
 at the University of South Florida and director of the Tampa General Hospital
 Outpatient Epilepsy Clinic.  "Other recent studies have shown that 75% of
 patients are likely to discontinue a selected drug therapy due to the
 potential for negative side effects.  These undesirable side effects that
 accompany many antiepileptic drugs may impede patients' overall therapy
 despite their effect on seizure control.  Our results suggest that VNS may be
 a treatment that allows for fewer necessary AEDs at lower effective doses.
 Not only were medications reduced, but over 76% of the patients saw a
 reduction in their seizures with VNS."
     VNS therapy is delivered by the Cyberonics NeuroCybernetic Prosthesis
 (NCP(R)) System, an implantable medical device similar to a cardiac pacemaker.
 A stopwatch-sized generator is implanted in the left chest and a nerve
 stimulation electrode is attached to the vagus nerve in the neck in a one to
 two hour procedure typically done on an outpatient basis.  Using an external
 programmer, the physician can set or reset the stimulation parameters of the
 device.  The System delivers preprogrammed intermittent electrical pulses to
 the vagus nerve 24 hours a day.  The first human implant of the system
 occurred in 1988 in a patient with epilepsy.  On July 16, 1997, the FDA
 approved VNS therapy with the Cyberonics NCP System as an adjunctive therapy
 for the treatment of medically refractory partial onset seizures in adults and
 adolescents over 12 years of age.  To date, more than 10,000 epilepsy patients
 in 24 countries have accumulated over 14,000 patient years of experience using
 Vagus Nerve Stimulation.  The most common side effects of VNS therapy seen in
 patients with refractory epilepsy are voice alteration, shortness of breath,
 discomfort and coughing, all of which occur during the actual stimulation.
 The NCP System is not authorized for use in the treatment of depression,
 obesity, Alzheimer's Disease or anxiety disorders and is in the early stages
 of investigation for these uses.
     Cyberonics, Inc. (www.cyberonics.com) was founded in 1987 to design,
 develop and market medical devices for the treatment of epilepsy and other
 debilitating disorders using a unique therapy, vagus nerve stimulation.  The
 Company's initial target market is epilepsy, the world's second most prevalent
 neurological disorder, which is characterized by recurrent seizures.  VNS with
 the Cyberonics NeuroCybernetic Prosthesis (NCP(R)) System was approved by the
 FDA on July 16, 1997 for use as an adjunctive therapy in reducing the
 frequency of seizures in adults and adolescents over 12 years of age with
 medically refractory partial onset seizures.  In addition to the U.S., the NCP
 System is currently approved for sale as a treatment for epilepsy in all the
 member countries of the European Union, Canada, Australia and other markets.
 VNS delivered by the NCP System is at various levels of investigational
 clinical study as a potential treatment for depression, obesity and
 Alzheimer's disease.  In March 2001, Cyberonics received CE Mark Approval to
 sell VNS in the member countries of the European Union as a treatment for
 patients with treatment resistant or recurrent depression.
     This press release contains forward-looking statements within the meaning
 of Section 27A of the Securities Act of 1933, as amended and Section 21E of
 the Securities Exchange Act of 1934, as amended.  Such forward-looking
 statements include statements concerning:  maintaining and obtaining
 appropriate regulatory approvals; transitioning VNS therapy from a
 revolutionary treatment to a standard of care in epilepsy; developing VNS as a
 treatment for depression, Alzheimer's Disease, obesity and other indications;
 the timing and outcome of clinical studies; improving our productivity and
 efficiencies; increasing our sales and achieving profitability.  These
 predications are based upon information presently available to us and
 assumptions that we believe to be reasonable.  We are not assuming any duty to
 update this information should those facts change or should we no longer
 believe the assumptions to be reasonable.  Our actual results may differ
 materially.  Important factors that may cause actual results to differ
 include: ongoing safety and efficacy of VNS with the Cyberonics NCP System;
 the overall rate of demand for the Company's products; the Company's ability
 to hire, train and retain key personnel; the Company's ability to maintain all
 appropriate regulatory approvals; the Company's ability to develop and
 maintain adequate manufacturing capacities and sources of supply; the timing
 and results of future clinical studies; and the amount of timing of
 expenditures related to those and other activities; and management's ability
 to accurately forecast future events.  For further discussion of these and
 other important factors that could affect the Company's activities and
 results, please refer to the Company's Annual Report on Form 10-K for the year
 ended June 30, 2000, and the Company's Quarterly Report on Form 10Q for the
 three months ended September 30, 2000 and December 31, 2000.
     NCP is a registered trademark of Cyberonics, Inc.  VNS is a trademark of
 Cyberonics, Inc.
 
 SOURCE  Cyberonics, Inc.