For Immediate Release: May 10, 2020 Media Inquiries: Michelle Bolek, 301-796-2973, [email protected] Consumer Inquiries: 888-INFO-FDA FDA issues alert…
 
READ MORE

For Immediate Release: May 10, 2020
Media Inquiries: Michelle Bolek, 301-796-2973, [email protected] Consumer Inquiries: 888-INFO-FDA
FDA issues alert on potential dangers of unproven treatment for multiple sclerosis
The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).
Some researchers believe that CCSVI, which is characterized by a narrowing (stenosis) of veins in the neck and chest, may cause multiple sclerosis (MS) or may contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord. However, studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.
“Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health. “Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes.”
The experimental procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. However, the FDA has learned of death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the experimental procedure. Balloon angioplasty devices and stents have not been approved by the FDA for use in treating CCSVI.
MS is a progressive, immune-mediated disorder of the brain and spinal cord. In MS, the lining around nerve fibers, and often the nerve fibers themselves, in the brain and spinal cord are injured, resulting in significant and disabling neurological symptoms. The underlying cause of MS is not known.
Complications following CCSVI treatment can be reported through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
The FDA also is notifying physicians and clinical investigators who are planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices. Any procedures conducted are considered significant risk clinical studies and require FDA approval, called an investigational device exemption.
In February 2012, the FDA sent a warning letter to a sponsor/investigator who was conducting a clinical study of CCSVI treatment without the necessary approval. The sponsor/investigator voluntarily closed the study.
The FDA will continue to monitor reports of adverse events associated with “liberation therapy” or the “liberation procedure” and keep the public informed as new safety information becomes available.
For more information:
Medical Device Safety
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

« Hide Text

International Healthcare Partners (IHP) has announced they have partnered with a lending institution to provide financing for Canadians…
 
READ MORE

International Healthcare Partners (IHP) has announced they have partnered with a lending institution to provide financing for Canadians obtaining healthcare outside of the country. The Synergy team is excited to announce this new option for financing as it opens many doors for Canadian patients.

For a $10,500 procedure, the monthly cost will be $254.73. This is an open loan. Providers will receive notice of financing approval and receive payment by wire transfer within 24 hours of notification that the procedure has been completed.

Deposits for the procedure will still be collected upfront with the option to finance the balance. The financing will be processed through IHP in conjunction with the Canadian lending firm and credit decisions will be available in minutes. Proof of approval will be supplied to Synergy.

The option for financing provides many more patients with the opportunity to travel to Synergy’s facilities and receive state-of-the-art care.

« Hide Text

The Society Of Interventional Radiology put this video together to share their research on the safety of using…
 
READ MORE

The Society Of Interventional Radiology put this video together to share their research on the safety of using Angioplasty to widen internal jugular and azygos veins.

« Hide Text

During much of 2011, Synergy Health Concepts performed all CCSVI procedures at Renaissance Surgery Center. At the end…
 
READ MORE

During much of 2011, Synergy Health Concepts performed all CCSVI procedures at Renaissance Surgery Center. At the end of 2011, Renaissance closed and filed for bankruptcy. Synergy continued providing CCSVI care at a local surgery center until our new facility opened in early January. As required by law, Renaissance Surgery Center has mailed a letter to all former patients asking if they would like copies of their medical records. Patients may wish to pursue this; however, all Synergy documentation including operative reports, balloons, stents, and other medical information is always kept by our medical records department. Synergy encourages any patients who have questions to contact our office, or the Renaissance trustee managing their bankruptcy.

Sincerely,

SHC

« Hide Text

At Synergy Health Concepts we have treated more CCSVI patients over the past year than any other clinic…
 
READ MORE

At Synergy Health Concepts we have treated more CCSVI patients over the past year than any other clinic in North America. Because we are constantly working with patients who want to schedule their CCSVI procedure, we know from our patients that the cost for treatment is a big hurdle in being able to get the treatment that each patient deserves. Because many insurance companies do not cover the CCSVI procedure, the total costs of the procedure, imaging, medications, airfare, hotel, and transportation add up quickly. This is why at Synergy we strive to improve each aspect of each patients experience with us which allows Synergy to minimize costs whenever and wherever possible.

Both over the past year and recently, Synergy has developed strong relationships with local, national, and international travel partners. Pacific Transportation Solutions is a local ground transportation service which focus’ on accessible transportation for local patients, as well as for all Synergy CCSVI patients. By developing a relationship with PTS, Synergy has streamlined the process of finding and utilizing ground transportation services while in Orange County for CCSVI care. By partnering with PTS, Synergy has negotiated special rates for our patients. If desired, all appointment times and dates with Synergy can be passed along to PTS to ensure your transportation is as stress free as possible during your stay in Orange County.

Earlier this year, Synergy was able to negotiate group rates for CCSVI patients at the Hyatt Hotel Newport Beach. By booking rooms at a large volume for our patients we were able to pass along the savings by providing free accommodations to all patients who travel from outside of our immediate area for their CCSVI care. This benefit to our patients includes complementary parking as well as a $50.00 voucher for food or drinks at Sol, the Hyatt’s in house restaurant.

Last month we solidified our relationship with International HealthCare Providers (IHCP). By working closely with IHCP, we were able to arrange for complementary companion airfare for patients traveling to Synergy via air travel. We require patients to have a companion with them during their medical care and most patients wish to bring a friend or family member during their travels. With this program, any patient who books air travel through IHCP will receive up to $500 off their companion’s airfare. At Synergy, we hope that this allows all patients to travel with someone during their CCSVI care.

Synergy Health Concepts is excited to announce that starting February 1st, any CCSVI patient who books air travel on WestJet through IHCP, will receive a 5% discount on their airfare. This new program will benefit anyone who wishes to travel on WestJet to Orange County. Currently WestJet offers direct flights from Canada into Santa Ana Orange County Airport (SNA). The Orange County Airport is only 5 miles from the Hyatt Newport Beach Hotel, and less than one mile from the Synergy offices in Newport Beach.

With the combination of these four travel options for CCSVI patient’s, Synergy leads the way in providing not only leading CCSVI care, but also affordable CCSVI care to our patients. Any patient wishing to speak with our office about their CCSVI questions, or questions regarding any of our travel initiatives, are encouraged to call our office at (877) RX-CCSVI, or (949) 221-0129.

« Hide Text

Dr. Hewett and a team of renowned industry experts, including Dr. Haacke, were published this month in the…
 
READ MORE

Dr. Hewett and a team of renowned industry experts, including Dr. Haacke, were published this month in the Journal of Vascular and Interventional Radiology.

Two hundred subjects with Multiple Sclerosis from two sites were evaluated with magnetic resonance imaging to quantify blood flow. The MS population was divided into two groups: those with evident internal jugular vein (IJV) stenoses and those without.

Of the 200 patients, 68 percent showed IJV structural abnormalities, including unilateral or bilateral stenoses at different levels in the neck. The total IJV flow normalized to the total arterial flow of the stenotic group was significantly lower than that of the nonstenotic group. The arterial/venous flow mismatch in the stenotic group was significantly greater than that in the nonstenotic group and the ratio of subdominant venous flow rate to dominant venous flow rate for the stenotic group was significantly lower than for the nonstenotic group.

Their research demonstrates that MR imaging provides a noninvasive means to separate stenotic from nonstenotic MS cases. The former group was more prevalent in the present MS population and carried significantly less flow in the IJVs than the latter.

At Synergy Health Concepts, we know that the best care in CCSVI treatment is founded upon ongoing research. In addition to the research outlined above, we are currently working on multiple IRB studies.

« Hide Text

Keeping a record of your personal medical history is an important step in managing one’s healthcare. Each doctor…
 
READ MORE

Keeping a record of your personal medical history is an important step in managing one’s healthcare. Each doctor and/or facility one visits will have a separate patient record; a personal health record will combine these separate records into a single, more complete record. This is especially important when consulting with a new physician. A majority of patients treated at Synergy Health Concepts travel to Costa Mesa from outside the state of California, which means their records from other doctors, and facilities are not always readily accessible or available. The doctors at Synergy will need certain records available to them in order to create the best treatment plan. Occasionally it will be requested that a patient send their records in at least one week prior to their scheduled pre-procedure consultation. During the CCSVI consultation patients will be asked to fill out various new patient forms (http://www.synergyhealthconcepts.com/for-patients/patient-forms/) that will call for detailed medical history. At the post-procedure follow-up patients will receive copies of their records to add to their personal health record, which will prove useful when following up with a primary care physician back home.

Patients who have received CCSVI treatment at another facility and are interested in coming to Synergy Health Concepts for a re-do procedure are encouraged to send in their previous procedure imaging and reports. Drs. Arata, Grewal, Harris and Hewett find it necessary to see the prior records to determine if the patient is a candidate for another CCSVI procedure. The records can be mailed to: Synergy Health Concepts, Attn: Medical Records, 4501 Birch Street, Newport Beach, CA 92660, or emailed to: [email protected]. After the images and report have been viewed the patient will receive a call to discuss the next step in their treatment plan.

At the consultation appointment, patients are asked to fill out a new patient packet. Included in this packet are questions regarding past medical history, below is a list of items you will need to know in order to comprehensively fill out the necessary documents:
• Emergency and local contact
• Date of last physical
• Dates and results of tests and screenings
• Major illnesses and surgeries, with dates
• A list of your medicines, dosages and how long you’ve taken them
• Any allergies
• Any chronic diseases
• Any history of illnesses in your family
Please have copies all of this information with you to expedite the paperwork process. A medical records release will also be filled out so that the patient may receive records after leaving the facility.

After the CCSVI procedure, patients at Synergy Health Concepts are scheduled for a follow-up appointment. At this appointment patients will receive a copy of their procedure imaging, in addition to a procedure report and copies of all of the paperwork they have signed. It is strongly recommended that each patient secures a pre and post CCSVI procedure appointment with their general practitioner before and after traveling to Synergy Health Concepts in Orange County, California. If paperwork is misplaced or imaging disc is damaged, one may email, [email protected], to request additional copies or call 949/221-0129 x202 with any health record related questions.

« Hide Text

As the CCSVI Patient Care Coordinator I am asked many questions by patients regarding their appointments and stay…
 
READ MORE

As the CCSVI Patient Care Coordinator I am asked many questions by patients regarding their appointments and stay in Orange County, California. Below is a list of the most frequently asked questions I receive during the scheduling process; also included is some helpful information pertaining to CCSVI treatment.

When I come to Synergy how long do I have to stay?
Your appointments at Synergy Health Concepts take place over the period of three days. The first day is reserved for the Haacke protocol MRV and consultation, the second day your tentative* procedure is scheduled, and the third day we will see you for a follow up. We do ask that you stay in the area for 48 hours post procedure. After that time you may travel. This usually works out to five days, four nights.
*the procedure is tentatively scheduled pending the consultation appointment

Do I have to stay in the hospital?
No. The procedure is done on an outpatient basis. After recovery you will be released to your adult accompaniment and advised to rest comfortably at your Hotel for the remainder of the day.

What if I do not have anyone to travel with me? Can I still schedule appointments with Synergy?
Yes. At Synergy we do require that there is someone with you 12-24 hours post operatively. If you are unable to have a family member or friend travel with you there are multiple caregiving services in the area that can provide the necessary care after the procedure. Just ask while scheduling and we can provide you with contact information to set up your caregiver. If additional nursing services are needed CNA’s and LVN’s are also available with these services. We are happy to provide referrals.

Can you help set up my flights and hotel?
Although at Synergy Health Concepts we do not assist with making reservations and flight plans; however, we do have a travel partner that assists our patients with all of their travel needs. You can reach International Health Care Partners at 866-227-8402 or visit their website at ihcproviders.com to make your travel arrangements.

I’m having an MRV. Are there any special instructions for this test?
The Haacke protocol MRV does not require you to fast but there are important points to discuss prior to booking your MRV with Haacke protocol. It is crucial when scheduling your MRV with Synergy Health Concepts that if you have any metals in your body such as a pacemaker, stent, shunt, or device from a prior surgery, it is made known at the time of scheduling. If so, the device needs to be cleared with the imaging center to make sure it is MRI safe. In addition, if you are claustrophobic we can provide sedation to make the test more comfortable for you. Please notate any claustrophobia on your intake form, or inform us when scheduling.

Does my insurance help pay for the procedure?
Some insurance companies do assist with the cost of your procedure with Synergy Health Concepts. Please forward a front and back copy of your insurance card to our office via fax: 949.223.4702 or e-mail our billing manager at [email protected] . We would be happy to check benefits for you.

I read the Pradaxa article on your website. Is there any other information regarding the medication I should know?
Yes, depending on where you visiting Synergy from the process of obtaining the medication can differ. Many Synergy patients from across the world are not sure if they will be able to obtain the prescribed three month regimen of Pradaxa post treatment. If you are not able to obtain Pradaxa prior to your scheduled procedure with Synergy we can provide the full three months of medication for you at a cost of $771.95. If you are an insured patient it is likely necessary to order the first month of medication through our office at a cost of $261.00. We will then provide a written script for the remaining two months. You can fill this with your local pharmacy and we will assist in getting it processed through your insurance. Because this process sometimes requires multiple appeals if the insurance does not allow please fill the prescription upon returning home to allow necessary time for the appeal process. The first dose of Pradaxa is administered the day of your procedure so it is necessary to have the medication the day of your treatment.

Is there any other information that you would need from me?
It is important as providers of your healthcare to have a well-rounded medical history of our patients. This includes recent blood work/labs, previous MRI’s, Doppler ultrasounds, previous procedure discs, and all other pertinent records. Having an account of your medical history allows us to monitor your progress with treatment and also consult with you in the future regarding your records. This includes reports as well as discs. If you are unable to copy your discs we will make sure when they are forwarded to our office that they are returned. If you have written reports they can be emailed to [email protected] or faxed to 949-223-4702.

The above questions are the most frequently asked when scheduling with Synergy Health Concepts but I would be happy to answer any others that you have along the way. Please do not hesitate to contact myself or the office if so. I would also like to mention that one of the greatest tools in answering questions regarding CCSVI and treatment with Synergy is exploring our website. There is great information available to potential patients including informational video, FAQ’s, news updates, supplement recommendations, and patient testimonials.

Crystal Conrad
Patient Care Coordinator
Synergy Health Concepts, INC
Orange County, CA

« Hide Text

Synergy Health Concepts takes pride in offering state-of-the-art facilities and top-of-the-line care for our patients. Undergoing any type…
 
READ MORE

Synergy Health Concepts takes pride in offering state-of-the-art facilities and top-of-the-line care for our patients. Undergoing any type of medical procedure can be a stressful and anxiety-provoking experience for anyone, especially when travelling abroad for it. We understand this and want to provide our patients with every comfort and security possible.

We will soon be moving into our new medical office building. It will be fully equipped with 4 patient examination rooms, 3 procedure rooms, and 7 pre-procedural and post-procedural recovery suites. This facility will allow us to provide every patient with the highest level of nursing and medical care. In addition to providing complete interventional medical care, we will also have a state-of-the-art 3 Tesla MRI and ultrasound machine. This will enable us to obtain the best imaging possible for our patients, including the Haacke Protocol MRI/MRV, Zamboni Protocol diagnostic ultrasound, as well as venous and arterial ultrasound imaging through the body, which gives us the ability to perform ultrasound-guided treatments such as vein ablations for varicose veins.

Patients receiving treatment at Synergy will be able to have all aspects of their care performed in one beautiful and well-equipped facility. This includes their diagnostic Haacke MRI/MRV, consultation with the physician, CCSVI procedure, follow-up CCSVI ultrasound, and post-procedural visit with the physician, giving patients peace-of-mind and comfort knowing that they will not have to be travelling in an unfamiliar place to receive the various components of their care. We strive to make this experience at Synergy Health Concepts as comfortable and pleasant as possible.

« Hide Text

Synergy Health Concepts is constantly striving to make the travel experience as stress-free and cost-effective as possible. With…
 
READ MORE

Synergy Health Concepts is constantly striving to make the travel experience as stress-free and cost-effective as possible. With that goal in mind, we have launched a new initiative to help our patients get the care they deserve. We are now offering a reimbursement up to $500 for your travel companion’s roundtrip airfare when booked through International Health Care Providers. All patients are strongly encouraged to bring a friend or family member to accompany them for their CCSVI procedure, and now they can do so at no additional cost.

Visit our Airfare and Accommodations page to learn more about this program.

« Hide Text