MyDepressionSpace.com

Cyberonics is unable to get partner for its depression therapy; vagus nerve stimulation ( VNS).

Today Cyberonics Inc., the manufacturer of the vagus nerve stimulator,  announced some very disappointing, but not surprising news:

Medical device maker Cyberonics Inc. said Wednesday it still has not found a partner for its depression system and reaffirmed its position that it will not conduct additional studies until it has found a collaborator. The company said it is now evaluating alternative actions that could help maintain regulatory approval while lowering its investment in the product.

We are in the fourth-year of FDA approval of vagus nerve stimulation therapy to treat major depressive disorder. In May of 2007, The Centers for Medicare and Medicaid Services  concluded that vagus nerve stimulation was not necessary to treat resistant depression, issued a final and binding National Coverage Decision of no coverage.

Vincent van Gogh's 1890 painting: On the Threshold of Eternity

For current VNS patients, the Company did announce "we remain committed to supporting patients and clinical partners." That is the good news. If you or a loved one currently has  the implant for depression, please do not worry. The President and Chief Executive of Cyberonics Inc.,  Daniel Moore,  has made it clear that you will continue to receive appropriate medical and clinical support.

It is also important to remember that Cyberonics is fully committed to its very profitable epilepsy business. The procedure for depression is identical to that of the procedure for epilepsy. The device is identical,  the surgery is identical and the programming of the device is identical.

Cyberonics employs over 440 people, has implanted 52,000 patients( epilepsy and depression) nationwide and has relationships with doctors in all fifty states. In the short term, this news is not really news. In the very long term, this news may ultimately be the catalyst for a much larger Company to conduct another trial for treatment-resistant depression--- a large, very well designed, double-blind, placebo-controlled with a long acute( blinded) period. Ideally I think the "blinded" portion of any future trial should be nine months.

For many patients( including me), there is a dramatic improvement in mood and depression that "kicks-in" after six months of stimulation. The design of the original trial had only an eight week fixed dosage of VNS, which apparently was one of the reasons for the  less than stellar results reported during the acute( short-term) portion of the trial. Secondly, scientists are currently researching dosing strategies as well as methods to determine appropriate patients for VNS Therapy(TM).

More on this tomorrow.

Johns Hopkins surgeon threatens to withhold VNS Therapy from epilepsy patients due to potentially lower reimbursement rates for lead replacement procedure. It is pitiful.

As most people already know,  Cyberonics  markets the Vagus Nerve Stimulation system, a pacemaker-shaped device that is implanted in the chest and sends electrical signals( via leads) to nerves in the neck. The government's Medicare program, which provides health care coverage to 44 million seniors, pays for the device when it is used to treat epilepsy. Vagus nerve stimulation therapy has improved the quality of life for many epilepsy patients.

On Wednesday The Centers for Medicare and Medicaid Sercives (CMS) held a meeting regarding reducing reimbursement rates to physicians for lead replacement surgery( not the initial surgery). The surgeon is compensated quite handsomely for the implant, a 90-minute out-patient procedure.

Apparently a surgeon  from Johns Hopkins Medical said at the meeting that, if the proposed cut becomes final, he would no longer insert the VNS Therapy System in patients. In other words he would deliberately withhold a treatment that improves the quality of a patient's life. I would like to know his name and contact information. It was a pitiful and indefensible remark. If anyone knows his name, please e-mail me. This type of inexcusable behavior must be arrested as soon as possible.

We live in a wonderful world. I would recommend that this doctor re-read the Hippocratic Oath. This is my favorite part of the Oath sworn by the surgeon:

To keep the good of the patient as the highest priority. There may be other conflicting 'good purposes,' such as community welfare, conserving economic resources, supporting the criminal justice system, or simply making money for the physician or his employer that provide recurring challenges to physicians.
 

What is the priority of this surgeon from Johns Hopkins?

What are the components of vagus nerve stimulation surgery, a 90 minute procedure?

Vagus nerve stimulation is an FDA approved treatment for both epilepsy and major depression. But just what are the components of the implant procedure:

• A generator to provide the appropriate stimulation to the vagus nerve;
• A lead that is attached to both the generator and the vagus nerve;
• Associated equipment to assist with necessary implantation surgery;
• Equipment to assist with setting the stimulation parameters particular to the patient;
• Appropriate instruction manuals; and
• Magnets to suspend or induce stimulation manually

The implantation of the generator and lead into patients is generally performed on an outpatient basis. The battery contained in this generator has a finite life, which varies according to the model, the stimulation parameters and settings used for each patient. At or near the end of the useful life of a battery, a patient may, with the advice of a physician, choose to implant a new generator, with or without replacing the original lead.

Pulse Generator.   The pulse generator is an implantable, programmable signal generator designed to be coupled with the bipolar lead ( see below ) to deliver electrical signals to the vagus nerve. The pulse generator is a battery powered device. Shortly before or upon depletion of the battery, the pulse generator may be removed and a new generator implanted in a short, outpatient procedure.

Above picture: vagus nerve in neck, the glossopharyngeal, vagus, and accessory nerves.

1. The Model 102, 102R, DemiPulse™  and DemiPulse™ Duo VNS Therapy pulse generators, the only pulse generators the manufacturer ( Cyberonics ) currently offers in the U.S., are similar in design and manufacture to a cardiac pacemaker. The generators are comprised of one printed circuit board and a battery hermetically sealed in a titanium case. Standard components are assembled on printed circuit boards using surface-mount technology. The assembled circuit boards are then tested and mounted with the battery in the titanium case, which is laser welded. A header to which the bipolar lead connects is added and each unit is subject to final release testing prior to being sterilized.
2. Bipolar Lead.   The bipolar lead conveys the electrical signal from the pulse generator to the vagus nerve. The lead incorporates electrodes, which are self-sizing and flexible, minimizing mechanical trauma to the nerve and allowing body fluid interchange within the nerve structure. The lead’s two electrodes and anchor tether wrap around the vagus nerve and the connector end is tunneled subcutaneously ( under the skin) to the chest where it attaches to the pulse generator. The leads are available in two sizes of inner spiral diameter to ensure optimal electrode placement on different size nerves.
3. Programming Wand and Software.  The Cyberonics programming wand and proprietary software are used to interrogate the device and to transmit programming information from a handheld computer  to the pulse generator via electromagnetic signals. Programming capabilities include modification of the pulse generator’s programmable parameters (pulse width, amplitude, frequency and ON and OFF intervals) and storage and retrieval of telemetry data.
4. Tunneling Tool.   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 assembly between the nerve site in the neck and the pulse generator site in the chest.
5. Accessory Pack.   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.

COMMENT: It all sounds very complicated for a 90-minute out-patient procedure, but it is not considered a risky or complicated surgery. For more information, I would visit VagusNerveStimulation.com

"Honey, I shrunk the Depression Business division."

We are now entering the fourth year of FDA’s final approval of vagus nerve stimulation to treat major depressive disorder.

Cyberonics continues to execute on its previously announced plan to focus primarily on the epilepsy market. From February 22^nd 2008 to April 25^th, a total of twenty-seven patients in the United States were implanted with the VNS Therapy System™ for depression. That is about one patient for every two states. Cyberonics continues to seek a financial partner or joint venture for a new depression clinical study.

Unfortunately, I think that universal reimbursement for non-pharmacological based treatments for mental health conditions (excluding ECT and psychotherapy) such as VNS, TMS, FEAST, and DBS is many years away.

Only twenty-seven patients were implanted with the VNS Therapy System(TM) for TRD during the past 90-days.

We are now entering the fourth year of FDA's final approval of vagus nerve stimulation to treat major depressive disorder. Cyberonics, the manufacturer of the vagus nerve stimulator continues to execute on its previously announced plan to focus primarily on the epilepsy market.

From February 22nd 2008 to April 25th, a total of twenty-seven patients in the United States were implanted with the VNS Therapy System^TM for depression. That is about one patient for every two states. Cyberonics continues to seek a financial partner or joint venture for a new depression clinical study.

Unfortunately, I think that universal reimbursement for non-pharmacological based treatments (excluding ECT and psychotherapy) such as VNS, TMS, FEAST, and DBS is many years away. Below is a painful reminder of Medicare's National Coverage Determination for vagus nerve stimulation (VNS):

"CMS (Centers for Medicare and Medicaid Services) believes almost all correctly identified depressed patients can be successfully treated for depression" [HELLO?]

"CMS has determined that there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment of resistant depression. Accordingly, we are issuing the following national coverage determination:

Vagus nerve stimulation is not covered for treatment resistant depression."*

Cyberonics, the medical device manufacturer of the vagus nerve stimulator, announces new management changes.

Today, medical device manufacturer ( of the  vagus nerve stimulator)  Cyberonics, Inc. made important organizational and  management changes. I think that this may be a net positive in improving both patient access to this therapy and reimbursement for the procedure. However, this is a very difficult topic to predict. Here are a few of the details:

Cyberonics, Inc. announced the appointment of James A. Reinstein as Vice President, Sales & Marketing, and General Manager, International, effective immediately. In this role, Mr. Reinstein will lead the sales and marketing effort in the United States and will be the general manager of Cyberonics Europe SA with responsibility for all sales and distribution outside the United States.

On paper, Mr. Reinstein  has strong medical device experience and hopefully will be a strong asset to the organization, patients and the medical community. Mr. Reinstein credentials are most impressive:

• 27 years with Boston Scientific Corporation, a worldwide $6 billion medical device company
• Vice-President of Boston Scientific Asia
• Inter-Continental Director of Marketing, European Group Marketing Manager, European Product Manager and U.S. marketing management and sales.

The President and Chief Executive Officer of Cyberonics has known Jim for over fifteen years. Mr. Moore commented about his demonstrated  leadership, business acumen and adaptability to working across different regions and cultures.

Leadership, business acumen and adaptability in working with others is the best medicine for this company. All I can do is be optmistic. I wish Mr. Rothstein great success in his new career.

Cyberonics, the manufacturer of the vagus nerve stimulator, announces significant management changes.

Cyberonics, the manufacturer of the vagus nerve stimulator (VNS Therapy System,TM), announced significant management changes. It reduced its employee  headcount by 15% and appointed a new President and Chief Executive Officer.

The new President and Chief Executive Office is Daniel J. Moore. Mr. Moore recently assumed the position of President, International Distributor Management at medical device manufacturer Boston Scientific Corporation. Boston Scientific is a huge company with over $6 billion in annual sales.   Prior to that role, he held the position of President, Inter-Continental, the fourth largest business unit of Boston Scientific with more than 1,000 global employees and revenues exceeding $700 million.  Mr. Moore previously held senior management positions at several Boston Scientific U.S. and International divisions.  He led Inter-Continental marketing during the initial launch of the TaxusT Drug Eluting Stent.

Cyberonics has been plagued with many distractions over the past year and a very challenging reimbursement environment for vagus nerve stimulation therapy to treat severe depression.

My initial take: The Centers for Medicare & Medicaid's impeding National Coverage Decision for vagus nerve stimulation therapy to treat resistant depression enormously important for its beneficiaries( the disabled and seniors over the age of 65). It's final ruling is due no later than May 6th.

I will post additional information on  these important changes later today.

Please be sure to visit the related mental health topics on this site

Very important week: Medicare's final and binding coverage of vagus nerve stimulation therapy to treat resistant depression.

This week the Center's for Medicare & Medicaid will issue its final and binding national coverage decision for vagus nerve stimulation to treat resistant depression. This is a crucial ruling for not only the disabled, seniors, and the economically disabled, but also for the patients covered by private health care plans. Medicare is the great equalizer and private health plans essentially follow the coverage decisions made by Medicare.

The initial non-coverage decision was void of any understanding psychiatry, treatment-resistant depression and the seriousness of the illness for Medicare's beneficiaries: the disabled and senior citizens age 65 and over.

Currently, Medicare fully covers the identical procedure( $26,500) if the diagnosis is  epilepsy. 100% of all private health plans cover the identical procedure if the diagnosis is epilepsy. However if the diagnosis is resistant depression, there is no national or universal coverage policy.

The world's largest health care organization needs to end its own discriminatory practices against treating its beneficiaries with severe depression by universally covering this 90-minute out-patient procedure. It will change the lives of the many people suffering from this disabling, debilitating and life threatening disease as well as the lives of their loved ones.

The vagus nerve stimulator is manufactured by Houston-based Cyberonics, Inc.

Please be sure to visit the related mental health topics on this site

Centers for Disease Control: "Chronic conditions such as depression cause pain and diminished daily functionality. View full report from the CDC.

Ask almost anyone how he or she would like to live their daily lives, and they'll tell you they want to be independent and active. Yet a new report finds more than four in five  Americans living with at least one chronic disease and half living with at least two, potentially cutting into the enjoyment of people's final decades. That's because chronic conditions such as high blood pressure, arthritis, heart disease, depression, cancer, diabetes and stroke can cause pain, diminished function and loss of independence.

The special report, released Thursday by the Centers for Disease Control and Prevention and the Merck Company Foundation, suggests these figures might get worse in coming years.

Click here for a full copy of the report from the Centers for Disease Control and Prevention

No one would choose pain, diminished function and a loss of independence, but that's potentially the result of decisions people make every day. Do you smoke? Do you exercise? Is your diet healthy? Do you abuse drugs or alcohol?

Recovery has taught me to respect, value and thrive to improve my health. I should have started earlier in life.

Post a comment  about one lifestyle change  you can  make that would help you improve the quality of your life. It may not only help yourself, but others could benefit from your suggestions.

15,000 patients have been prescribed vagus nerve stimulation therapy for depression.

The manufacturer of the vagus nerve stimulator, Cyberonics Inc., recently published some very interesting statistics about vagus nerve stimulation therapy for treatment-resistant depression(TRD):

• 15,000 patients have been prescribed vagus nerve stimulation therapy(VNS) for depression
• 3,400 psychiatrist have prescribed VNS Therapy for at least one patient
• Only 3,000 patients have been implanted, primarily due to reimbursements issues
• 250 private health plans have reimbursed for at least one case of VNS Therapy for TRD
• Medicare, Medicaid and the Veterans Administration have reimbursed VNS for TRD
• 100% of all private and public health plans fully reimburse VNS Therapy for epilepsy patients
• 40,000 patients have  safely been implanted with the VNS Therapy System-primarily epilepsy patients

VNS Therapy(TM) is FDA approved for both pharmaco-resistant epilepsy and for treatment-resistant depression. I always thought that if a procedure is FDA approved then healthcare plans must cover the procedure. As we have learned that is inaccurate.

For treatment-resistant depressed patients, reimbursement decisions are being made on a case-by-case basis. Obviously this is discriminatory and time consuming. According to the manufacturer, it has taken as long as nine months for a final decision to be made. It is appalling.

I know first-hand that the waiting process is very frustrating. In November of 2000, I had my first interview to be considered as a study subject in the double-blind, placebo-controlled  investigational trial of vagus nerve stimulation to treat severe depression. I was approved to be a study subject in March of 2001 and finally implanted on April 4th, 2001. The waiting process was grueling, but ultimately it was worth it.