Cyberonics, Inc. Acknowledges Receipt of FDA Warning Letter Regarding Medical Device Reporting

FDA Considers Cyberonics' Responses to Be Adequate



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

    HOUSTON, April 11 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq:   CYBX) today
 reported that it had received a warning letter dated March 23, 2001 from the
 Dallas District office of the United States Food and Drug Administration (FDA)
 regarding the Company's noncompliance with the Medical Device Reporting
 Regulation (MDR), as specified in Title 21, Code of Federal Regulations (CFR),
 Part 803.  The letter followed an inspection of Cyberonics' Houston facilities
 on January 22 to 25, 30 and February 1, 2001.  The letter is available on the
 FDA's website http://www.fda.gov/foi/warning.htm and can be found by searching
 under Cyberonics.  In the conclusion of the letter FDA states:
 
     "You (Cyberonics) should take prompt action to correct these violations.
 Failure to promptly correct these violations may result in regulatory action
 being initiated by the Food and Drug Administration without further notice.
 These actions include, but are not limited to, seizure, injunction, and/or
 assessing civil money penalties."
     "We (FDA) acknowledge the receipt of your firm's response, dated February
 22, 2001, provided to us at the district meeting on February 23, 2001, and
 additional responses faxed on March 1 and 12, 2001, responding to the
 inspectional observations (FDA-483).  As part of your firm's corrective action
 plan to address the system level issues, your firm has now submitted all death
 (83) and infection (116) events to FDA, made some organizational changes,
 hired additional senior management staff, revised and added procedures,
 provided updated employee training to address the shortcomings in the areas of
 device handling and CAPA (Corrective Action Preventative Action) activities,
 and plan to utilize a third party auditor to facilitate improvement in your
 quality systems.  We consider your responses to be adequate and will verify
 the effectiveness of your corrective action at the next scheduled inspection."
 
     Robert P. Cummins, Cyberonics' President and Chief Executive Officer
 commented, "Cyberonics highly values its relationship with the FDA and we have
 obviously taken the warning letter seriously considering the timeliness and
 adequacy of our responses.  Since FDA approval in July 1997 we have carefully
 tracked complaints and consistent with Post Market Surveillance Requirements
 included in our PMA approval letter, we have reported all deaths of patients
 treated with VNS in our Annual Reports to the FDA.  The results from two
 separate studies of mortality rates and Sudden Unexplained Death (SUDEP) rates
 in VNS patients were published in the February 1998 and May 2000 editions of
 Epilepsia.  Those studies and the mortality and SUDEP rates in the VNS cohort
 included in our Annual Reports to FDA suggest that mortality and SUDEP rates
 among VNS patients are equal to or lower than the mortality and SUDEP rates
 from published studies of patients suffering from medically refractory
 epilepsy not treated with VNS."
     "We were in the process of recruiting new regulatory affairs and quality
 leadership prior to FDA's inspection in late January," continued Mr. Cummins.
 "As previously announced, this recruiting process resulted in the hiring of
 Alan Totah on February 11, 2001 as Vice President of Regulatory Affairs and
 Quality Assurance.  Alan has over 20 years of Class III medical device
 regulatory affairs and quality management experience at Intermedics and
 Medtronic.  Since joining Cyberonics, Alan has successfully recruited key
 regulatory affairs and quality management personnel with relevant medical
 device experience at Guidant, St. Jude Medical, Abbott Labs and Intermedics.
 Alan and his team should be congratulated on the timeliness and adequacy of
 Cyberonics' response to FDA's observations."
     Mr. Cummins concluded, "Many device manufacturers, large and small,
 receive warning letters from FDA regarding compliance with the Medical Device
 Reporting Regulation.  Considering that FDA has deemed our response to be
 adequate and that Cyberonics has demonstrated its firm commitment to full
 compliance with all regulations, we do not believe that FDA's warning letter
 dated March 23 will adversely impact our sales or future product approvals."
     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.  Vagus
 Nerve Stimulation (VNS(TM)) 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
 reported that it had received a warning letter dated March 23, 2001 from the
 Dallas District office of the United States Food and Drug Administration (FDA)
 regarding the Company's noncompliance with the Medical Device Reporting
 Regulation (MDR), as specified in Title 21, Code of Federal Regulations (CFR),
 Part 803.  The letter followed an inspection of Cyberonics' Houston facilities
 on January 22 to 25, 30 and February 1, 2001.  The letter is available on the
 FDA's website http://www.fda.gov/foi/warning.htm and can be found by searching
 under Cyberonics.  In the conclusion of the letter FDA states:
 
     "You (Cyberonics) should take prompt action to correct these violations.
 Failure to promptly correct these violations may result in regulatory action
 being initiated by the Food and Drug Administration without further notice.
 These actions include, but are not limited to, seizure, injunction, and/or
 assessing civil money penalties."
     "We (FDA) acknowledge the receipt of your firm's response, dated February
 22, 2001, provided to us at the district meeting on February 23, 2001, and
 additional responses faxed on March 1 and 12, 2001, responding to the
 inspectional observations (FDA-483).  As part of your firm's corrective action
 plan to address the system level issues, your firm has now submitted all death
 (83) and infection (116) events to FDA, made some organizational changes,
 hired additional senior management staff, revised and added procedures,
 provided updated employee training to address the shortcomings in the areas of
 device handling and CAPA (Corrective Action Preventative Action) activities,
 and plan to utilize a third party auditor to facilitate improvement in your
 quality systems.  We consider your responses to be adequate and will verify
 the effectiveness of your corrective action at the next scheduled inspection."
 
     Robert P. Cummins, Cyberonics' President and Chief Executive Officer
 commented, "Cyberonics highly values its relationship with the FDA and we have
 obviously taken the warning letter seriously considering the timeliness and
 adequacy of our responses.  Since FDA approval in July 1997 we have carefully
 tracked complaints and consistent with Post Market Surveillance Requirements
 included in our PMA approval letter, we have reported all deaths of patients
 treated with VNS in our Annual Reports to the FDA.  The results from two
 separate studies of mortality rates and Sudden Unexplained Death (SUDEP) rates
 in VNS patients were published in the February 1998 and May 2000 editions of
 Epilepsia.  Those studies and the mortality and SUDEP rates in the VNS cohort
 included in our Annual Reports to FDA suggest that mortality and SUDEP rates
 among VNS patients are equal to or lower than the mortality and SUDEP rates
 from published studies of patients suffering from medically refractory
 epilepsy not treated with VNS."
     "We were in the process of recruiting new regulatory affairs and quality
 leadership prior to FDA's inspection in late January," continued Mr. Cummins.
 "As previously announced, this recruiting process resulted in the hiring of
 Alan Totah on February 11, 2001 as Vice President of Regulatory Affairs and
 Quality Assurance.  Alan has over 20 years of Class III medical device
 regulatory affairs and quality management experience at Intermedics and
 Medtronic.  Since joining Cyberonics, Alan has successfully recruited key
 regulatory affairs and quality management personnel with relevant medical
 device experience at Guidant, St. Jude Medical, Abbott Labs and Intermedics.
 Alan and his team should be congratulated on the timeliness and adequacy of
 Cyberonics' response to FDA's observations."
     Mr. Cummins concluded, "Many device manufacturers, large and small,
 receive warning letters from FDA regarding compliance with the Medical Device
 Reporting Regulation.  Considering that FDA has deemed our response to be
 adequate and that Cyberonics has demonstrated its firm commitment to full
 compliance with all regulations, we do not believe that FDA's warning letter
 dated March 23 will adversely impact our sales or future product approvals."
     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.  Vagus
 Nerve Stimulation (VNS(TM)) 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.