Re: A question about helmets?

[Guest guest]

HI Kelli,

There are a lot of different band/helmets that treat plagio. They all

do the same thing, in the right hands!! Your ortho HAS to be

experienced. That is key to success!! Please keep us posted.

Welcome to the group!

> Are there basically 2 types,the STAR & the DOC?

[Guest guest]

Kelli:

The DOCband made by Cranial Technologies & the STARband made by

Orthomerica are the 2 most commonly used products, but there are

other bands and helmets our there. We have a list of FDA

approved " cranial molding orthosis " in our " files " section *I

think*. Let me take a look for you.

There are also locally made helmets made by local hospitals. The

locally made helmets are usually of a passive design, meaning they

don't apply any pressures the the non flat side of the baby's head,

the passive helmets are simply shaped the way the child's head should

be and rely on growth spurts to get improvement, as the child's head

grows, it will grow into the gap left in the flat area of the helmet.

The STAR & DOC band are both " aggressive " meaning they apply VERY

(not felt by the child at all) slight pressures to the non flat side

of the baby's head to help push the other side out while slowing down

the growth of the good side, allowing the flat side to catch up

some.

Click here for a comparison chart of the DOCband and STARband,

http://www.plagiocephaly.org/support then click " compare cranial

molding orthosis " .

Hope this helps, I got a bit long winded, hope I didn't confuse you!

Debbie Abby's mom DOCGrad

MI

> Are there basically 2 types,the STAR & the DOC?

[Guest guest]

> Are there basically 2 types,the STAR & the DOC?

Kelli,

The STARbands and DOCbands are actually two examples of an active

design for cranial orthosis. Basically, when getting a moulding

device, you have two choices....either a passive design (your locally

made helmets) or an active design. The STARbands and DOCbands do

seem to be more common, but there are quite a few FDA approved

devices out there. As good timing would have it, I just received an

email from Orthomerica with a list of different FDA approved designs

which I'll paste below. I do just want to reitterate though, that

success with any device is dependant upon an expereienced and

knowledgable ortho!

Niki

Here's that list for you:

FDA Cleared Cranial Remolding Orthoses

" The FDA regulates cranial remolding orthoses to assure their safety

and effectiveness. These rules regulate various aspects of the

design, clinical evaluation, manufacturing, packaging, labeling,

commercial distribution and postmarket surveillance of cranial

remolding orthoses. " 1 It is important for parents to make sure their

infant receives an FDA cleared orthotic design. The following

information is provided to assist parents in their efforts to find

effective orthotic care for their infants. All orthotic designs and

manufacturers listed below adhere to the strict guidelines

established by the FDA in regards to the manufacture of cranial

remolding orthoses for positional plagiocephaly.

510(k) Number

Name of Orthosis

Applicant

Date of Clearance

K021918

Clarren Helmet (Orthomerica)

Orthomerica Products, Inc.

6333 N. Orange Blossom Trail

Orlando, FL 32810

07/25/02

K021207

STARlight Cranial Remolding Orthosis

Orthomerica Products, Inc.

6333 N. Orange Blossom Trail

Orlando, FL 32810

07/09/02

K021221

O & P Cranial Molding Helmet

Orthotic & Prosthetic Lab, Inc.

748 Marshall Ave.

Webster Groves, MO 63119

07/01/02

K020448

Static Cranioplasty Orthosis

Eastern Cranial Affiliates

2525 North Tenth Street, #804

Arlington, VA 22201

04/12/2002

K013700

Orthosis Helmet Molding

Precision Prosthetics & Orthotics, Inc.

5353 Wayzata Blvd., #505

Minneapolis, MN 55416-1334

02/05/2002

K013719

Becker Band Cranial Remolding Orthosis

Becker Orthopedic Appliance Co.

635 Executive Dr.

Troy, MI 48083

02/05/2002

K014012

DOC Band

Cranial Technologies, Inc.

1395 West Auto Dr.

Tempe, AZ 85284

01/28/2002

K012804

Plagiocephalic Applied Pressure Orthosis

Fit-Well Prosthetic and Orthotic Center

50 South 900 East, #1

Salt Lake City, UT 84102

01/17/2002

K012920

Molded Cranial Helmet

Fairview Orthopedic Laboratory

220 S. 6th Street

Minneapolis, MN 55402-1498

11/28/2001

K012830

Lerman & Son Cranial Orthosis Helmet

Lerman & Son

8710 Wilshire Blvd.

Beverly Hills, CA 90211

11/20/2001

K013458

Cranial Helmet

Children's Hospital

5353 Wayzata Blvd.

Minneapolis, MN 55416-1334

10/29/2001

K012007

RHS Helmet

Restorative Health Svs., Inc.

1301 K Street, N.W.

Suite 1100 – East Tower

Washington, DC 20005-3373

09/19/2001

K011350

STARband Cranial Remolding Orthosis

Orthomerica Products, Inc.

6333 N. Orange Blossom Trail

Orlando, FL 32810

07/03/2001

K011433

Ballert Cranial Molding Helmet

GEMA, Inc.

2434 W. Ave.

Chicago, IL 60659

06/12/2001

K003035

Clarren Helmet

Children's Hospital & Medical Center

1301 K Street, N.W., #1100

Washington, DC 20005

06/06/2001

K003630

Michigan Cranial Helmet

Danmar Products, Inc.

221 Industrial Dr.

Ann Arbor, MI 48103

05/29/2001

K010273

Cranial Molding Orthosis

Orthotic Solutions, Inc.

2802 Merrilee Dr., #100

Fairfax, VA 22031

04/25/2001

K001669

Hanger Cranial Band

Hanger Orthopedic Group, Inc.

2 Bethesda Metro Center

Bethesda, MD 20814

12/08/2000

K000861

Craniocap

Gillette Children's Specialty Healthcare

1785 Gold Court

Eagan, MN 55122

10/30/2000

K001167

OPI Band

Orthomerica Products, Inc.

6333 N. Orange Blossom Trail

Orlando, FL 32810

07/07/2000

K964992

DOC Band

Cranial Technologies, Inc.

1331 North 7th St., #170

Phoenix, AZ 85006

05/29/1998

1 http://www.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

[Guest guest]

i just wanted to tell you good luck on your appt...your at a great age for correction also...trust me when i say that i know where you are at..i too blamed myself for my sons plagio...i spent many nights crying and torturing myself...its not your fault...your being a great mommy for noticing and taking the steps to correct it...thats a great big pat on the back!!...keep your chin up...after casting we waited aprox 2 weeks...we had the docband tho..good luck again and keep us posted..

brenda

mom of tucker

Re: A question about helmets?

> Are there basically 2 types,the STAR & the DOC?Kelli,The STARbands and DOCbands are actually two examples of an active design for cranial orthosis. Basically, when getting a moulding device, you have two choices....either a passive design (your locally made helmets) or an active design. The STARbands and DOCbands do seem to be more common, but there are quite a few FDA approved devices out there. As good timing would have it, I just received an email from Orthomerica with a list of different FDA approved designs which I'll paste below. I do just want to reitterate though, that success with any device is dependant upon an expereienced and knowledgable ortho!NikiHere's that list for you:FDA Cleared Cranial Remolding Orthoses "The FDA regulates cranial remolding orthoses to assure their safety and effectiveness. These rules regulate various aspects of the design, clinical evaluation, manufacturing, packaging, labeling, commercial distribution and postmarket surveillance of cranial remolding orthoses."1 It is important for parents to make sure their infant receives an FDA cleared orthotic design. The following information is provided to assist parents in their efforts to find effective orthotic care for their infants. All orthotic designs and manufacturers listed below adhere to the strict guidelines established by the FDA in regards to the manufacture of cranial remolding orthoses for positional plagiocephaly. 510(k) Number Name of Orthosis Applicant Date of Clearance K021918 Clarren Helmet (Orthomerica) Orthomerica Products, Inc.6333 N. Orange Blossom TrailOrlando, FL 32810 07/25/02 K021207 STARlight Cranial Remolding Orthosis Orthomerica Products, Inc.6333 N. Orange Blossom TrailOrlando, FL 32810 07/09/02 K021221 O & P Cranial Molding Helmet Orthotic & Prosthetic Lab, Inc.748 Marshall Ave.Webster Groves, MO 63119 07/01/02 K020448 Static Cranioplasty Orthosis Eastern Cranial Affiliates2525 North Tenth Street, #804Arlington, VA 22201 04/12/2002 K013700 Orthosis Helmet Molding Precision Prosthetics & Orthotics, Inc.5353 Wayzata Blvd., #505Minneapolis, MN 55416-1334 02/05/2002 K013719 Becker Band Cranial Remolding Orthosis Becker Orthopedic Appliance Co.635 Executive Dr.Troy, MI 48083 02/05/2002 K014012 DOC Band Cranial Technologies, Inc.1395 West Auto Dr.Tempe, AZ 85284 01/28/2002 K012804 Plagiocephalic Applied Pressure Orthosis Fit-Well Prosthetic and Orthotic Center50 South 900 East, #1Salt Lake City, UT 84102 01/17/2002 K012920 Molded Cranial Helmet Fairview Orthopedic Laboratory220 S. 6th StreetMinneapolis, MN 55402-1498 11/28/2001 K012830 Lerman & Son Cranial Orthosis Helmet Lerman & Son8710 Wilshire Blvd.Beverly Hills, CA 90211 11/20/2001 K013458 Cranial Helmet Children's Hospital 5353 Wayzata Blvd.Minneapolis, MN 55416-1334 10/29/2001 K012007 RHS Helmet Restorative Health Svs., Inc.1301 K Street, N.W.Suite 1100 – East TowerWashington, DC 20005-3373 09/19/2001 K011350 STARband Cranial Remolding Orthosis Orthomerica Products, Inc.6333 N. Orange Blossom TrailOrlando, FL 32810 07/03/2001 K011433 Ballert Cranial Molding Helmet GEMA, Inc.2434 W. Ave.Chicago, IL 60659 06/12/2001 K003035 Clarren Helmet Children's Hospital & Medical Center1301 K Street, N.W., #1100Washington, DC 20005 06/06/2001 K003630 Michigan Cranial Helmet Danmar Products, Inc.221 Industrial Dr.Ann Arbor, MI 48103 05/29/2001 K010273 Cranial Molding Orthosis Orthotic Solutions, Inc.2802 Merrilee Dr., #100Fairfax, VA 22031 04/25/2001 K001669 Hanger Cranial Band Hanger Orthopedic Group, Inc.2 Bethesda Metro CenterBethesda, MD 20814 12/08/2000 K000861 Craniocap Gillette Children's Specialty Healthcare1785 Gold CourtEagan, MN 55122 10/30/2000 K001167 OPI Band Orthomerica Products, Inc.6333 N. Orange Blossom TrailOrlando, FL 32810 07/07/2000 K964992 DOC Band Cranial Technologies, Inc.1331 North 7th St., #170Phoenix, AZ 85006 05/29/1998 1 http://www.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm For more plagio info

[Guest guest]

Amy,

Welcome to the group. Your certainly not alone in your thinking when you

start blaming yourself looking with hindsight, but as they say, hindsight is

always 20/20. In hindsight, my son's plagio started inutero, but not one

Doctor ever pointed out that his eye looked a little smaller, head looked

squished on the left side, and we never saw it either, we were smitten. CT

took one look at his 2 day old pic, and said, yeah, definetly. It made me

feel like I should have seen it too. We should be harder on the paid

professionals for letting us down, than on ourselves, they come into contact

with tons of kids, and have much more knowledge, or should have. I'm glad to

hear that your little one is on his way to getting that helmet, and onto a

rounder noggin!

I think its pretty typical to expect some crying, and if you can bring a

lollipop, or a musical toy, or sippy cup, favorite stuffed animal, anything

to help distract from the moment might help. I will tell you that nothing we

did worked for my son- but it was literally over in 10 min. I would recommend

having Dad there too, extra hands to help hold him and another set to get the

props going and the distractions. Good luck to you and please keep us

posted. Try to remember that your doing a great job for your child by

getting educated, you have one lucky baby to have such a caring, and

concerned mom.

' Mom

[Guest guest]

Amy so happy that you have found us welcome aboard. We have another ballert

family so Hope they chime in you will be great support for one another. First

you sound like a wonderful mommy doing the best she can so don't beat

yourself up because the DR's lead you astray. If you want to beat anyone up

beet up the guy who told you Cranio man I would like to kill him. Probably a

man with no kids-make sure you write a complaint letter about him to the

hospital administrator so they can get him more education and not scare

another mommy half to death. With that said............. Adam is still a

great age to see good results with the helmet so your fortunate that you and

your DR were proactive and you didi not get the it will roundout on its own

story. I would leave the who what where and how in the background and you

have the right attitude what's done is done and now you are moving forward to

do what is best for your son. The helmet is wonderful intervention and so

effective as well. CASTING- ugh well go to our files section here is a link

and take a look we have many good tips what worked for me

1. take someone with you to help

2. he will get abath when it is done maybe take a big fuzzy towel or toy

3. we played his favorite CD in the room- which helped for a milli second but

it kept me focused on singing to him and trying to keep him calm

4. we introduced suckers when he felt that in his mouth and the taste he was

like hhhmm what is this- then he started crying later:-)

5. take a bottle

6. in the exit casting we kept a t shirt on him that I didn't care if it got

ruined by plaster and he did better- maybe because he wasn't naked I don't

know. He laughed through his exit casting and this seemed to be the only

thing different and his age of course.

When the kids are young helmets generally come in quicker but I would be

willing to bet 10 days for you - I am not real familiar with ballert sorry.

Most kids adjust without problem and some have a harder times than others.

One Mom suggests wearing a cap on your sons head from now until he gets his

helmet and that might work.

You sound like a good Mom with a great attitude we are so glad you are here.

God luck Friday and be sure to let us know how it goes!

beck

Mom to and

Memphis

[Guest guest]

Hi all. I'm a new member and have already learned so much--reading all of your e'mails (including who's older than who I'm 30....but more importantly my son, Adam, is 5 1/2 mons old. I want to share my story (vent) and would love to read any comments/suggestions you guys can offer.

At his 4 mon appt. I mentioned that several people had pointed out a flat spot on Adam's head. My pediatrician was pro-active and recommended a CT scan. We had that done two days later and the !%@$%@^%@$ radiologist interpreted the CT as craniostenosis of the left lamboidal suture. So, off to the neurosurgeon we went----it took a month to get in for that consult. Meanwhile, we didn't try any positional changes, because I was under the impression that his little bones were fusing prematurely and had nothing to do with position. I hadn't noticed him favoring that side and he doesn't have tort. Anyway, the neurosurg informed us that his sutures were fine and that it was "positional plagiocephaly". Suggested the helmet vs. trying to do the positioning thing. I just don't think we'd be able to keep him from rolling around now---he'll be free-er in the helmet. His appt witht he othotist is on Friday--for the casting. I saw some pics of what to expect on the CAPPS website. I can only guess how much of a fuss Adam will make. Any suggestions to make the ordeal any less of an ordeal?? He doesn't take a pacifier. I'm sure it's harder on me, than on him.

My other issue is how guilty I feel about my baby's deformed head. I have no idea if it's mild, mod or severe (the neurosurg pointed out how his ears are assymetrical---which seems to be common with all of your kids too), but feel like I should have done something. Like I said before, I never noticed him laying towards that side----but he must have been....how else would his head have gotten flat. It wasn't in utero or during the whole birthing process. What's done is done---now I just want to fix it.

So, Friday will be our big day. Going to Ballert (as per neurosurg rec). How long should it take to get the helmet--after the casting?? How long did it take your kids to adjust to having the helmet on. Hopefully it's no big whoop. We'll find out soon enough.

Amy

Plainfield, Illinois

Re: A question about helmets?

> Are there basically 2 types,the STAR & the DOC?Kelli,The STARbands and DOCbands are actually two examples of an active design for cranial orthosis. Basically, when getting a moulding device, you have two choices....either a passive design (your locally made helmets) or an active design. The STARbands and DOCbands do seem to be more common, but there are quite a few FDA approved devices out there. As good timing would have it, I just received an email from Orthomerica with a list of different FDA approved designs which I'll paste below. I do just want to reitterate though, that success with any device is dependant upon an expereienced and knowledgable ortho!NikiHere's that list for you:FDA Cleared Cranial Remolding Orthoses "The FDA regulates cranial remolding orthoses to assure their safety and effectiveness. These rules regulate various aspects of the design, clinical evaluation, manufacturing, packaging, labeling, commercial distribution and postmarket surveillance of cranial remolding orthoses."1 It is important for parents to make sure their infant receives an FDA cleared orthotic design. The following information is provided to assist parents in their efforts to find effective orthotic care for their infants. All orthotic designs and manufacturers listed below adhere to the strict guidelines established by the FDA in regards to the manufacture of cranial remolding orthoses for positional plagiocephaly. 510(k) Number Name of Orthosis Applicant Date of Clearance K021918 Clarren Helmet (Orthomerica) Orthomerica Products, Inc.6333 N. Orange Blossom TrailOrlando, FL 32810 07/25/02 K021207 STARlight Cranial Remolding Orthosis Orthomerica Products, Inc.6333 N. Orange Blossom TrailOrlando, FL 32810 07/09/02 K021221 O & P Cranial Molding Helmet Orthotic & Prosthetic Lab, Inc.748 Marshall Ave.Webster Groves, MO 63119 07/01/02 K020448 Static Cranioplasty Orthosis Eastern Cranial Affiliates2525 North Tenth Street, #804Arlington, VA 22201 04/12/2002 K013700 Orthosis Helmet Molding Precision Prosthetics & Orthotics, Inc.5353 Wayzata Blvd., #505Minneapolis, MN 55416-1334 02/05/2002 K013719 Becker Band Cranial Remolding Orthosis Becker Orthopedic Appliance Co.635 Executive Dr.Troy, MI 48083 02/05/2002 K014012 DOC Band Cranial Technologies, Inc.1395 West Auto Dr.Tempe, AZ 85284 01/28/2002 K012804 Plagiocephalic Applied Pressure Orthosis Fit-Well Prosthetic and Orthotic Center50 South 900 East, #1Salt Lake City, UT 84102 01/17/2002 K012920 Molded Cranial Helmet Fairview Orthopedic Laboratory220 S. 6th StreetMinneapolis, MN 55402-1498 11/28/2001 K012830 Lerman & Son Cranial Orthosis Helmet Lerman & Son8710 Wilshire Blvd.Beverly Hills, CA 90211 11/20/2001 K013458 Cranial Helmet Children's Hospital 5353 Wayzata Blvd.Minneapolis, MN 55416-1334 10/29/2001 K012007 RHS Helmet Restorative Health Svs., Inc.1301 K Street, N.W.Suite 1100 – East TowerWashington, DC 20005-3373 09/19/2001 K011350 STARband Cranial Remolding Orthosis Orthomerica Products, Inc.6333 N. Orange Blossom TrailOrlando, FL 32810 07/03/2001 K011433 Ballert Cranial Molding Helmet GEMA, Inc.2434 W. Ave.Chicago, IL 60659 06/12/2001 K003035 Clarren Helmet Children's Hospital & Medical Center1301 K Street, N.W., #1100Washington, DC 20005 06/06/2001 K003630 Michigan Cranial Helmet Danmar Products, Inc.221 Industrial Dr.Ann Arbor, MI 48103 05/29/2001 K010273 Cranial Molding Orthosis Orthotic Solutions, Inc.2802 Merrilee Dr., #100Fairfax, VA 22031 04/25/2001 K001669 Hanger Cranial Band Hanger Orthopedic Group, Inc.2 Bethesda Metro CenterBethesda, MD 20814 12/08/2000 K000861 Craniocap Gillette Children's Specialty Healthcare1785 Gold CourtEagan, MN 55122 10/30/2000 K001167 OPI Band Orthomerica Products, Inc.6333 N. Orange Blossom TrailOrlando, FL 32810 07/07/2000 K964992 DOC Band Cranial Technologies, Inc.1331 North 7th St., #170Phoenix, AZ 85006 05/29/1998 1 http://www.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm For more plagio info