STARband family helmets are approved by the U.S. Food and Drug Administration (FDA)
Presently, more than 600K babies have been treated with STARband.
The success rate of STARband treatment is greater than 95%.
Orthomerica has been a manufacturer of STARband brand skull straightening orthoses since 2001.
To date, STARband orthotic helmets have been used on more than 600 thousand babies.
95% success rate proven by research.
Deformational Plagiocephaly is commonly known as Flat Head Syndrome, Oblique Head or Parallel Head.READ MORE
Deformational Brachycephaly is defined by a skull that is centrally flattened at the back of the head as well as extremely wide from ear to ear.READ MORE
Deformational scaphocephaly is characterized by a long head shape that is narrowed on the sides.READ MORE
Since 2000, Orthomerica has been producing STARband orthoses to the world.
We have been serving as Cranial in Turkey since 2013.
STARband orthotic helmets have been applied to more than 600,000 infants worldwide.
There are more than 800 STARband centers worldwide.
FDA is affiliated with the United States Department of Health; is responsible for food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary instruments and cosmetics. The roots of this organization, which has 110 years of experience and knowledge, go back to 1906. The purpose of its establishment is to present the scientific and comprehensive researches they have done on the products in question to the public in order to provide the products that will be necessary for a healthy life with the highest quality, and to protect the public health. The abbreviation FDA stands for U.S. It is the Food and Drug Administration and its Turkish equivalent is "American Food and Drug Administration". The organization consists of 9 separate sub-units such as Drug Evaluation and Research Center, Food Health and Nutrition Center, Medical Devices and Radiology Research Center. FDA; It is the most respected inspection authority in its field, which is accepted worldwide.
If the device or product to be used has the approval of the FDA (U.S. Food and Drug Administration); This indicates that the production conditions of the device or product in question are suitable for health, that it provides the promised effect, that it does not cause any damage to the person while providing this effect, that it can maintain this effect within the promised period and that it will not show any unexpected side effects in the future. Getting this approval requires an average of 5 years of serious inspection and observation process. Therefore, the reliability of devices and products that do not have FDA approval and promise great effects should be questioned. You can find a list of FDA-controlled and approved products at www.fda.gov.
The most important feature of STARband is the end of the treatment with only one helmet. More than 99% of patients with deformational plagiocephaly and brachycephaly who are treated with helmets end the treatment with a single helmet, even if it is very extreme. With its integrity in the STARband design, it allows to make arrangements that will allow the full recovery of the head shape during the treatment. This allows our orthotic technicians to make strategic intervention decisions throughout the treatment to achieve the best results for each patient at each visit.
You are not putting your baby at risk by starting helmet therapy. The FDA does not approve the use of devices that will endanger public health. STARband does not put your baby's normal development at any risk.
Most importantly, STARband helmets are FDA-approved as they have been proven to be effective, that is, straightening your baby's head. The helmet applied to your baby is not manufactured anywhere, but is manufactured specifically for your baby in accordance with the standards under the control of FDA, in Orthomerica facilities. At the same time, the FDA requires that your baby be followed up by a certified orthotic technician after the STARband helmet is applied.
STARscanner is designed only for the production of STARband helmets, that is, for the 3-dimensional (3D) measurement of infants' head deformations, evaluation of helmet treatment and monitoring of STARband helmets and their full recovery by strategically intervening inside.
Like STARband helmets, the STARscanner Data Collection System has been approved by the FDA. Since it is not harmful, FDA has approved STARscanner in a Class 1 scanning device category.
With 4 laser readers and 8 cameras in STARscanner, it scans with a high sensitivity of +/- 0.5mm. This sensitivity is specially designed according to the needs of your baby's head deformation and normal shape in the special program for STARband. This design is reflected in the production of your baby's helmet, again in millimeters, with the same precision.
Your baby's head shape is monitored by the STARscanner Data Collection System at each visit. By making millimetric comparisons with previous scans, improvement is observed at each visit. You and your doctor can follow where and how much the improvement is, both visually and numerically.
At the same time, your Orthotic Technician evaluates your baby's improvement at each scan and decides where, how much and when to strategically intervene inside your STARband helmet for full recovery.
Orthomerica has been producing special cranial straightening orthoses (Helmet) for more than 600+ babies in more than 800 cranial centers around the world on an area of ??10 thousand square meters since 2000 under the brand STARband.
STARband is a big family. Under the umbrella of STARband, hundreds of people work devotedly to deliver the best results and in the fastest way without any errors. At the same time, thousands of pediatricians, neurosurgeons, physiotherapists, technicians, academics and information technology specialists from all over the world contribute to the development of the STARband helmet treatment program with a multidisciplinary approach. That's why STARband is a huge family that follows constantly improving research. However, STARband and STARscanner are preferred in many studies conducted in the world.
STARband orthoses can only be intervened by orthotic prosthesis graduate technicians with STARband certificate. Students must successfully complete the STARband cranial course organized by the International Institute of Orthotics and Prosthetics (IIOP). They continue to undergo intensive training until they are competent to intervene strategically on helmets. Even after that, the trainings continue to follow the current developments and practices.
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