St. Jude Medical Announces European Regulatory Approval of First Implanted Neurostimulation Device to Treat Chronic Migraine

CE Mark approval expands treatment options for patients suffering from the pain and disability associated with intractable chronic migraine.

According to a Business Wire press release St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has received the industry’s first and only regulatory approval for the use of an implanted neurostimulation device for patients with intractable chronic Migraine. The company received European CE Mark approval for its Genesis neurostimulation system for peripheral nerve stimulation (PNS) of the occipital nerves for the management of the pain and disability associated with intractable chronic Migraine. This type of Migraine is defined as headache lasting at least four hours per day for 15 or more days per month, causing at least moderate disability, and not responding to three or more preventive drugs.

“Through my participation in this study, I have observed the life-changing potential this therapy offers chronic Migraine patients.”

You can get an idea of how the Genesis sytem would be deployed to delivery its mild electrical pulses to the occipital nerves that are located just beneath the skin at the back of the Migraineurs head.

PNS therapy for this condition involves the delivery of mild electrical pulses to the occipital nerves that are located just beneath the skin at the back of the head. A small electrical lead or leads are placed under the skin and connected to the neurostimulator which produces the pulses of stimulation.

“As a professor and practicing neurologist who works with these patients on a daily basis, I see firsthand the challenges they face in trying to manage their pain and disability and how chronic Migraine impacts their lives and their families,” said Dr. Stephen D. Silberstein, past president, American Headache Society, director of the Jefferson Headache Center, and has been a trusted advisor to MAGNUM on Migraine disease issues is the principal investigator in a recent St. Jude Medical chronic Migraine clinical trial. “Through my participation in this study, I have observed the life-changing potential this therapy offers chronic Migraine patients.”

The CE Mark approval was supported by the results of St. Jude Medical’s chronic migraine study, a randomized, double-blind, controlled study that collected data from 157 patients. On average, participants enrolled in the study suffered from (Migraine) headache 26 days per month.

The largest clinical study to date evaluating PNS to treat chronic Migraine utilized various measures including the Migraine Disability Assessment (MIDAS) questionnaire, subjective assessment scales and daily patient diaries to report headache intensity, frequency, duration and medication use. At 12 weeks, patients in the active group reported an average of seven fewer headache (Migraine) days a month as measured by the MIDAS questionnaire compared to only a one day per month decrease in the control group (non-stimulation group). In addition, overall disability as measured by MIDAS demonstrated that participants in the active group showed a 41% improvement after 12 weeks of stimulation, compared to a 13% improvement in the control group.

Results at one year included:

  • 65 percent of patients reported excellent or good pain relief
  • 88 percent said they would recommend the procedure to someone else
  • 68 percent of patients expressed that their quality of life had improved
  • 67 percent were satisfied or very satisfied with the results of their procedure

Results of the major study endpoints were presented in abstract and poster format at the International Headache Congress in Berlin in June 2011. Study data will be submitted for publication in medical journals later this year and early 2012.

“This CE Mark is the first approval by a regulatory body for the use of neurostimulation to manage the debilitating symptoms of intractable chronic migraine and provides a new option for patients who have generally exhausted all other treatment options,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “For more than six years we have worked with our investigators to develop and evaluate this life-changing therapy. We will continue to work with regulatory authorities to secure approvals in order to offer this therapy option to patients throughout the world.”

Some Additional Background on St. Jude Medical Neuromodulation Division:

Three Decades of Leading-Edge Neurostimulation Technology

For more than 30 years, the St. Jude Medical Neuromodulation Division has developed new technologies to treat chronic pain and other neurological disorders. Today more than 75,000 patients in 40 countries have been implanted with St. Jude Medical neurostimulation systems. Focused on research, St. Jude Medical is developing new technologies to address a growing list of neurological disorders. Additional clinical studies are currently underway for Parkinson’s disease, essential tremor, major depressive disorder, and other significant indications.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn., and has four major focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.


Drug Options for Migraine Sufferers

For many a Migraine suffer Midrin® was the first prescription a white-coat jutted down on a Rx tablet.  It was our first trip to the pharmacist to get help for a horrible health problem.  For a great deal more of us it was the first step in our health struggle to be taken serious.  God bless Ed Bergeron, former President of Carnrick Laboratories—the pharmaceutical company that created that beloved maroon capsule called Midrin.

You guessed it the company is no longer in the game, to bad as it was a great little patient first company. Mike & Terri both interview Ed in the 1990’s and Carnrick Laboratories gave MAGNUM our first small grant in 1996 as the company was very supportive of Migraine disease awareness beyond digital marketing games of any type.

After years of false starts attempting to address the fact that that for some of us our quality of life was beginning to slip away and if one more doctor told us to just take more OTCs (Over The Counter drugs) we would want to scream!

But alas we get our first Rx filled and upon our next prodrome (good move & drug working so much better) if we are Migraine literate if not we will wait till our head is splitting in half (not such a good move) and deploy that first real medicine for a life-long serious condition and to our surprise several hours later a moderate Migraine is ‘under control’.

This was a whole new experience to say the least for many of us.  Such fond memories can be found all around the nation judging by phone calls, letters,  and e-mails which is why MAGNUM likes to call this the ‘Great Midrin®’ shortage beginning several years ago and the panic began!

No, really, a real panic mind you did happen.  People were genuinely shocked when the FDA began going after the DESI drugs with the new Administration and the lead up the The Patient Protection and Affordable Care Act (PPACA).

What direct connections there are we have no idea.  But we do know a great deal of older bio-engineered drugs are no longer with us just as we are seeing a great deal of generics disappear in the past two years.  Time will tell if this is experts clearing out the deadwood or bureaucracy being overly efficient, which often leads down a road of inefficiency turning left on ironically ally.

As far as coverage of the slow loss of Midrin from your local pharmacy there have been only a few well written articles about the subject.  Besides www.MigraineBlog.org‘s coverage our friend Migraine Health Advocate Teri Robert did some top notch coverage such as Migraine Abortive Midrin and Equivalents Update Feburary 9th, 2011. on the Migraine.com network.

Having said that let us all consider that generic Midrin is gone for good sans our friends who are compounding the cute little capsules.  Well don’t panic as we spoke to nationally renowned Migraine Expert, with an eye in alternative treatments and we are sure many readers have seen him before.  We would like you to meet Dr. Alexander Mauskop of CNN, FOX TV News, or MSNBC TV News fame?

Dr. Mauskop and MAGNUM Executive Director Michael John Coleman discussed the Midrin crisis as Director Coleman noticed Dr. Mauskop’s spend years of his life as well as  put a great deal of his own money into developing a over the counter anti-Migraine drug called “Migralex®?

Like Midrin having both abortive properties and pain fighting properties having synergy to our old friend Midrin.  But his drug Migralex® is base on magnesium, a well known Migraine fighting agent. Migralex® like Midrin® his medicine is compounded, but unlike Midrin it is compounded with aspirin an NSAID which is well known to be very effective in the correct doses. Now aspirin if over used in very large amounts every few hours by its self can be problematic you may have heard—leading to rebound headache.

But rebound is NOT an issue as you are protected from it by just following the directions and taking the FDA recommended dose every 4 to 6 hours.  We have had a great deal of positive feedback about Migralex® and it offers readers a readily available Migraine medicine to purchase online today to replace your empty Midrin bottle. You can visit Dr Mauskop’s popular Migraine Blog, and make sure you discuss with you attending physician you might have found a milder buy very effect replacement for the defunct Midrin in case you has special health issues; such as health issues with magnesium or to say aspirin.

Next on our list of replacement players up at bat is an old friend the ever popular GelStat® Migraine.  GelStat came to MAGNUM’s attention as the first over the counter Migraine drug that offered an abortive capacity for the Migraine patient.  Now we thought this was great as triptans, though very effective, are very costly. GelStat® Migraine is very effective at just $8.00 for a box of 4 separate 2ml oral doses.

Now GelStat is based on feverfew, a tried and true alternative treatment being used for Migraine for hundreds of years.  But only till recently do we have quality testing, some of which can be viewed at the GelStat website for your perusal www.GelStat.com. We also have some background on fever.  Few on our Alternative Treatment section of www.migraines.org if you are still looking for more on the plant this drug is based on.

We have some excellent feedback and we have others who this does not seem to be that effective.  Several years ago we gave a hard working auto mechanic who cannot afford time off for a bad Migraine several boxes to try.  With the exception for a severe ER Migraine he was trilled effectiveness of this odd little pill that you take sublingual (under the tongue).

We can’t believe we are giving Excedrin® Migraine a free plug but this would not be good journalism if we did not point best last replacement player if our metaphoric team is kinda short and does not look like he is major league.  Having said that we would like to draw you attention to a quality product, yes MAGNUM will say it, but with this caveat–Excedrin® Migraine can be very effect for many of us who suffer from Migraine, but only those who suffer from mild Migraines, and an occasional moderate Migraine.  But children do not try Excedrin® Migraine on a severe or god forbid on a profound Migraine because the medication will fail and you will need a triptan or an ergot in short order.  So please discuss this with your doctor, but our idea would be for Migrainuers who suffer with mild to moderate Migraines you can consider this as a full time replacement for your RIP Midrin.  But talk to you doctor about having abortive such as a triptan around to take on your breakthrough attacks.  You may be able to get by with a few samples if you severe attacks are so rare.  Which is why Excedrin® Migraine is something you may consider as you say goodbye to Midrin® for good.

Of course if someone decides to put it back in production MAGNUM will be the first to let you know.  But we have come so far, so don’t get your hope up!  So say bye bye to that that last bottle you have been holding on to, as those Midrin pills are getting pretty long in the tooth any way and they are not going back into production.  Rest in peace little maroon pill! (OK; RIP to generic maroon & white little pills too!)


Managing The Stress of Selling Your Home

Selling Your Home Can Be a Headache

Managing Stress During the Home Selling Process

Selling a home can give you an unmanageable migraine. The Huffington Post says that people often experience higher stress levels when going through the various stages of the home selling process. Studies show that the inspection process seems to be the most nerve-wracking experience for almost every seller.

Showing their home is not fun for sellers either, and then there is the appraisal process which can be a stomach churning experience. So, how do you stay calm and keep your stress levels manageable without running for the medicine cabinet and minimize the adverse effects that can be associated with selling your home?

Here are the top five tips we’ve found that should keep you sane during the sale of your home:

1. Preparation is key

No matter whether you are packing up the house, cleaning out the closets, or trying to find out how much your home is worth, planning is the best thing you can do to stay ahead of surprises and minimize your stress level. If you are a first time seller, then knowing what to expect ahead of time is the best way to combat the fear of the unknown.

Many sellers go into the property transfer process with blinders on not taking the time to research what to expect or how to find the most reputable appraiser. By learning about the processes that go along with selling a home, you can minimize anxiety because you know what to expect even if you do not know the ins and outs.

2. Get rid of clutter

You hear this statement all the time, but do how do you organize a whole home clearing without pulling your hair out? With the majority of home buyers searching online, the pictures of your home are critical to the sale.  Organize your clean out by room, function, or floor level depending on the time you set aside for cleaning. For instance, if you only have a few hours, then maybe it is best to tackle the bedroom closets or the mudroom first.

If you have a large block of time that you can set aside for sorting through your home, then you can tackle the attic, basement, or an entire room. To get even more work done in a short time, ask family and friends to help out. Forbes says to make three piles, sell, trash, and donate. If you plan to get rid of many extras, then you can order a dumpster, have a yard sale, or ask the thrift store to pick up your donations.

3. Take time for reflection and quiet time

One way to help yourself in the heat of the moment is to have a go-to meditation method or breathing exercise. You can do a grounding technique where you look for five things that you can touch, four things you can see, and so forth. Another way to get a hold of yourself when things get out of control is to breathe in and out slowly counting to five each way.

Practice stress relieving exercises before the selling process begins to get the most benefits. By practicing stress-reducing techniques when you do not need them, you can train your brain to go to the technique quickly in the heat of the moment. When the selling process becomes overwhelming, you know what to do to get immediate relief from the strain.

Simple stress reducers

Fox News says several things can minimize your stress levels. Some of the most helpful tips include:

  • Think about a “happy place”
  • Practice accepting things you cannot change
  • Eat something healthy
  • Go for a walk
  • Take a break from electronics or social media
  • Limit email checks to once or twice a day
  • Start taking vitamins
  • Work out
  • Take a nap
  • Light an aromatherapy candle
  • Take a hot shower
  • Organize something
  • Check off something on your to-do list to feel like you are making progress

4. Plan a Vacation During the Week of Showing

If you are the person that freaks out at every little change, mistake, or delay, then perhaps it is a better idea to remove yourself from the situation. For instance, the week of the appraisal, you can book a spa appointment and let your agent meet with the home analyst.

When the home is ready to show to, and you have the date for the open house, you should consider taking a mini-vacation when the home viewing is on the weekend. If you are showing your house during the summer, try to combine your vacation with the same week the real estate agent is showing your property to get your mind off of everything. Entrepreneur says that you can keep your house spiffier if you get out of the way when you are ready to show the home because there is nothing to clean up.

5. Delegate, Delegate, Delegate

Whether you are getting the home ready for the inspection, need help cleaning out the basement, or you have a ton of phone calls to make, spread the work out. Ask your spouse to help make the phone calls, split up chores between each member of the family. Call your in favors or throw a moving party.

You can also hire help when you cannot do the lifting or moving. Plan ahead to make sure you have plenty of extra hands when you are on a tight deadline to make the process a little easier. If you book a facial or a massage immediately after the stressful event, then you know you have something to look forward to when you are going through the roughest parts of selling your home.

When you feel like the walls are closing in and you need a distraction, breathing through the moment is a fantastic way to get over hard times and, sometimes it’s important to just get out of the situation and give yourself a moment to reset. Sometimes, venting to someone is a great way to relieve stress too.

Selling your home is going to come with surprises, but you can control how you deal with them.


migraines

Dealing with Migraines

Migraines, they are a literal pain in the head. Almost 5 millions Americans experience the burden of a migraine at least once a month. What exactly are they, and what causes them? Migraines are severe headaches that cause throbbing in one particular area of the head. Symptoms that come along with these vicious headaches include nausea and sensitivity to light, these symptoms may vary in intensity depending on the person. Although researchers are not completely certain on what causes migraines, many believe migraines involve complications with brain chemicals and nerve pathways. Omitting the past belief that migraines are caused by constricted blood vessels in the head, The Migraine Research Foundation has stated that they believe migraines are a collection of severe neauroligical symptoms as well as the fact that they are confident that there is more they can do for the victims of migraines.

Migraine Diagnosis

Migraines are usually self-diagnosiable, but for others who can not diagnose themselves, doctors can run blood tests as well as MRI or CT scans to further explore the issue. Once a patient is diagnosed with migraines, they are offered a wide variety of treatment options such as pain relievers and  caffeine combination drugs. Although these treatments may not completely omit the pain of migraines or the chances of getting another one, it does lower the risks. Patients can also try just simply relaxing and trying to get a full eight hours of sleep every night. Home remedies that may help reduce the pain of migraines include natural oils such as peppermint oil and basil oil. Peppermint oil helps open and close vessels, as many migraines are often caused by poor blood flow. Basil oil is a natural muscle relaxant, so it aids in relaxing tight muscles in the head.

Who Gets Migraines?

Migraines are unfortunately heredity, so it is important for families to know how to manage their migraines, if it does happen to be in their genes.If either parent gets migraines there is a 50-75% chance that their child will as well.  Families may be able to target who inherited the migraine gene by talking about family member’s past history with migraines. Understanding how others helped ease the pain of their migraines, may aid victims for their future head aches. This may also help victims be alert and aware as to what triggers these severe head aches as well as what symptoms come along with them. Those living with the trouble of migraine are also encouraged the keep a headache diary that includes triggers and symptoms along with the consistency of their migraines.

Personal Experiences with Migraines

I personally have had many traumatic experiences with migraines. My attacks would last about a week and gradually get worse day by day until it was so excruciating that I could not leave my bed. I would have to put up black out curtains in my room and stuff my head inside my pillows. Even the slightest noise or shining lights brought so much pain to me that even thought of standing up upset my stomach. I could not eat for my stomach was so nauseated, and even if I attempted to, I would just throw my food back up. One of the things that helped me during this times was BC powder, a powder formula that contains 845 mg of aspirin and 65 mg of caffeine. Although it took me a long time to discover this wonderous powder, I was very glad that I did.  The pain from a migraine can justifiably be bad enough to drive someone to take heavy drugs and end up in a rehab. This seemed to be the only thing that could ease the pain of my headaches. Although this worked for me personally, this may not be the best option for other migraine victims. Many people prefer more natural treatments such as massage therapy or natural oils as I mentioned earlier. Another effective option is increasing vitamin and mineral intake. Many people say that acupuncture, a form of alternative medicine where thin needles are inserted into the body, works for them. Studies show that acupuncture helps relieve the pain of migraines by increasing blood flow and stimulating nerves and muscles. In contrast to that, many people belief pain medications work best for them. Anti-seizure medications such as valporic acid and torpiramate reduce migraine chances because they contain neurotransmitters. Some people prefer the all natural way, while others would rather pain relief drugs. It all depends on the person and how severe their migraines are as well as what works best for them.

Conclusion

In overview, migraines are very burdensome and the 6th most disabling disease in the United States. Many people are still trying to learn about what triggers their migraines as well as how to treat them properly. Although the chance of getting another migraine may be very troubling to those who have had one of this terrible headaches, there is hope for victims as researchers are studying more on what causes them and how to properly treat them.

 


living drug free

Drug Rehabilitation Program Benefits

Drug Rehabilitation Programs

There is nothing to be ashamed of when looking for a drug rehab clinic. In fact, you are taking a brave step in overcoming your addiction by finding an accredited rehabilitation center. From inpatient rehab to outpatient rehab, there are so many benefits and ways to find the best treatment center to meet all your needs. While you may not be in the best state of mind, there is also no shame in asking friends or loved ones for help. In fact, they can help find the best center, along with comparing online reviews and industry testimonials. Remember, drug rehab help is also about emotional and moral support from your family members and friends.

Rehab Center Services

alcohol addictionWhether dealing with alcohol addiction or substance abuse, local rehab centers are committed to helping you get your life back. This is done via proper nutritional guidance, along with personal counseling, group counseling, activities, and medicines that help the body and mind recover from substance abuse. Drug rehab centers feature compassionate and caring doctors, nurses, mental-health experts and staff. Each team member plays a key role in helping you cope and overcome your addiction. Form anxiety and depression to drugs and alcohol, each program is customized and designed specifically to help you tackle and defeat addiction!

Which Rehab Center to Go With?

Finding a good and reputable drug rehab center does not have to be hard. Again, you should reach out to loved ones and friends that can help you. Remember, your family members and friends love you and will always be there every step of the way. By simply acknowledging that you have a drug addiction – that is literally winning half the battle. These centers not only help you medically and mentally, they can truly change your life at every turn. In fact, with guidance counselors and physicians – drug rehab teams are able to help you avoid triggers that lapses back into addition.

This is done by:

•    Educating and informing you on the best ways to avoid alcohol, drugs, tobacco or other harmful substances.
•    Teaching you how to love yourself, while reconnecting with your body, mind, spirit and soul.
•    Embracing your beliefs, ethics and morals – never judging you – and helping you become a strong-minded and independent person that will no longer need “crutches” to combat daily trials and tribulations of life.
•    Helping you improve your health with proper eating habits, rest, exercise, activities, and staying positive even in the most negative situations!

Getting Help

The single most important thing is admitting you need help.  Admitting you need help can be the most challenging part but is an important first step. Once you have broken down that interior barrier with yourself, you can start on the road to recovery.