Cyberonics gets FDA approval to expand implant study
Cyberonics, Inc. recently announced that the United States Food and Drug Administration (FDA) has approved an expansion of the D-02 depression pivotal study to include up to an additional 30 implanted patients. The original D-02 depression pivotal study protocol permitted up to a maximum of 275 patients to be enrolled and up to 210 patients to be implanted at up to 20 study sites. Earlier this week, Cyberonics announced that the 210th and final patient was implanted approximately three months ahead of the original D-02 study plan. Cyberonics requested expansion of the D-02 study at the request of investigators and already enrolled patients who would have otherwise been denied participation in the study. Enrollments in the D-02 depression pivotal study have been completed. The up to 30 additional patients to be implanted are already enrolled and have tentative surgery dates. The additional up to 30 patients will likely be implanted by July 31, 2001. This expansion of the D-02 depression pivotal study will likely have no effect on study unblinding which is expected to occur by March 2002.
Robert Cummins, Cyberonics' President and Chief Executive Officer, commented, "We are extremely pleased that the FDA approved this request to expand the study in less than two weeks, so that up to 30 already enrolled patients with chronic or recurrent depression will be given the opportunity to receive VNS treatment. Cyberonics' mission in depression is to improve the lives of people touched by chronic or recurrent depression including patients and their families, psychiatrists and payers. Our efforts to expand the D-02 study and our willingness to incur the additional costs underscore our vigorous pursuit of our mission. The additional patient experience will strengthen the overall D-02 study and not result in any delays. We remain on track to complete and unblind the D-02 depression pivotal study in the January through March 2002 timeframe. Given positive D-02 study results, we anticipate submitting the depression PMA by June 30, 2002 to FDA for their review."
"Depression is increasingly and more widely being recognized as a major public health problem that adversely impacts patients, their families, clinicians, payers and employers," continued Mr. Cummins. "According to the 1999 Surgeon General's Report on Mental Health(www.surgeongeneral.gov/library/mentalhealth/home.html), 7% of Americans are suffering from a mood disorder at any one time and mood disorders take a monumental toll in human suffering, lost productivity, and suicide. About 10% to 15% of patients formerly hospitalized with depression commit suicide and an estimated 500,000 Americans visit emergency rooms each year due to attempted suicide. According to a report in today's Wall Street Journal, depression's annual toll on U.S. businesses amounts to about $70 billion in medical expenditures, lost productivity and other costs. Study results presented at this year's American Psychiatric Association Meeting by Drs. Stan Finkelstein and Ernst Berndt of the Massachusetts Institute of Technology and Drs. William Crown and Davina Ling of MEDSTAT demonstrated that the average annual healthcare costs for patients treated with at least two antidepressants and hospitalized for depression totaled over $40,000 per year."
Mr. Cummins concluded, "The goal of our depression pivotal study program is to at the time of launch in the United States have the acute and long term clinical study data, the neuroimaging, neurochemical and sleep mechanism of action research and the health economics and cost effectiveness data which demonstrates to FDA, psychiatrists, payers, employers and patients and their families that VNS is a safe, tolerable and effective treatment for over one million Americans suffering from chronic or recurrent depression."
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. 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 30 minute to one and a half 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.
The Company's initial market is epilepsy, the world's second most prevalent neurological disorder, which is characterized by recurrent seizures. VNS with the Cyberonics NCP 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. To date, more than 11,000 epilepsy patients in 24 countries have accumulated over 14,000 patient years of experience using VNS. VNS delivered by the NCP System is at various levels of investigational clinical study as a potential treatment for depression, obesity, anxiety disorders and Alzheimer's disease. VNS with the Cyberonics NCP System was recently approved for sale in the European Union and in Canada as a treatment of depression in patients with treatment resistant or treatment intolerant major depressive episodes including unipolar depression and bipolar disorder (manic depression).
Source: Cyberonics, Inc.
Subscribe to our free e-mail newsletter.
Click for a free Buyer's Guide listing.