jawsurgeryforums.com
General Category => Functional Surgery Questions => Topic started by: Lestat on January 30, 2017, 01:00:22 PM
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The CHALLENGE
ELIMINATE RESORPTION & INFECTION
Conventional materials used in facial bone contouring procedures have significant weaknesses. Patients receiving autologous bone transplants experience unpredictable resorption and reduction of bone volume whereas alloplastic implants, such as plastics and titanium, have risks of exposure and infection.
OUR SOLUTION
CUSTOMIZED REGENERATIVE IMPLANTS
Due to the proprietary calcium phosphate-based material composition, reinforced by titanium, and CAD-based manufacturing and design, OSSDSIGN® Facial provide new clinical opportunities for treatment of various facial bone deformities.
The material composition based on calcium phosphate has several positive effects on the surrounding tissue, including upregulation of collagen deposition1. The implants are reinforced by non-exposed titanium, based on CAD design and manufacturing, allowing a flexible yet stable implant solution for facial reconstruction.
http://www.ossdsign.com/customized-implants-for-facial-bone-Augmentation
https://3dprint.com/163163/ossdsign-3d-printed-implants/
(http://www.ossdsign.com/upl/images/485025.jpg)
What are your thoughts?
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The CHALLENGE
ELIMINATE RESORPTION & INFECTION
Conventional materials used in facial bone contouring procedures have significant weaknesses. Patients receiving autologous bone transplants experience unpredictable resorption and reduction of bone volume whereas alloplastic implants, such as plastics and titanium, have risks of exposure and infection.
OUR SOLUTION
CUSTOMIZED REGENERATIVE IMPLANTS
Due to the proprietary calcium phosphate-based material composition, reinforced by titanium, and CAD-based manufacturing and design, OSSDSIGN® Facial provide new clinical opportunities for treatment of various facial bone deformities.
The material composition based on calcium phosphate has several positive effects on the surrounding tissue, including upregulation of collagen deposition1. The implants are reinforced by non-exposed titanium, based on CAD design and manufacturing, allowing a flexible yet stable implant solution for facial reconstruction.
http://www.ossdsign.com/customized-implants-for-facial-bone-Augmentation
https://3dprint.com/163163/ossdsign-3d-printed-implants/
(http://www.ossdsign.com/upl/images/485025.jpg)
What are your thoughts?
sounds like ct bone implant
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sounds like ct bone implant
OssDsign has FDA approval since three days. CT-Bone is not even yet available in Europe.
I wonder if OssDsign is better than Peek. Only god knows...
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Sounds neat. But I think one should remember with these "stiff" implants the amount of augmentation in any one operation is quite limited. Still, this looks very interesting for areas that are traditionally hard to augment.
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OssDsign has FDA approval since three days. CT-Bone is not even yet available in Europe.
I wonder if OssDsign is better than Peek. Only god knows...
yes but the material looks give or take the same. Any doctors commenting on it like eppley or yaremchuk?
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yes but the material looks give or take the same. Any doctors commenting on it like eppley or yaremchuk?
Why do they call it regenerative? Its only regenerative if the implant is totally colonized by bone cells or acts like live bone (i.e. able to self-repair if injured etc..)
We need to know more, but I feel the word "regenerative" here is misleading and a scam.
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Why do they call it regenerative? Its only regenerative if the implant is totally colonized by bone cells or acts like live bone (i.e. able to self-repair if injured etc..)
We need to know more, but I feel the word "regenerative" here is misleading and a scam.
I don't know if I would use the word scam, but again it sounds like like ct bone implant its a synthetic implant that is very close biologically to bone
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I wonder how many patients have had this material implanted, given the very short nature of the FDA clearance. I would like to hear the what the surgeons think of it, before coming to any conclusions.
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I don't know if I would use the word scam, but again it sounds like like ct bone implant its a synthetic implant that is very close biologically to bone
I don't think that's true. Biological bone is ALIVE with bone cells and marrow cells and blood vessels. There isn't any of that stuff nor alive bone cells in this calcium phosphate. Honestly, I think all they mean here is that it's not rejected by the body since it's already made of calcium and that maybe blood vessels can grow into it. But they grow into medpor too. That doesn't make the medpor "alive". Seriously one bump to the phase and if this calcium phospate shatters or breaks it won't heal back into place. That's the fundamental test right there. So calling it regenerative is TOTALLY and ABSOLUTELY misleading.
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More about bone regeneration:
https://www.ncbi.nlm.nih.gov/pubmed/28117976
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Has anyone contacted the company? ???
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Has anyone contacted the company? ???
The million dollar question. Just ask them if that implant either is colonized by real bone after time (and if so how) and/or what happens after you've had it for a year and that area is injured. Will it "join" or heal like real bone? If not it's just a brittle implant.
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I like their approach. They seem "cosmetic augmentation" oriented, which sounds refreshing, since you wouldn't have to justify yourself too much to benefit from it.
As far as I got it, they are already experimenting it in Europe ?
I may sound foolish, but I would be willing to test it, sounds as safe as hydroxyapatite to me.
Gonna ask my surgeon about it.
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Well, let's contact them, seems more promising than CT-bone. Who are the knowledgeable members who know a good list of questions to ask? I'd be interested in contacting.
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When you read "FDA approved" don't immediately think they are talking about the USA FDA. Many other countries have analogous regulating agencies called the FDA, like thailand for example.
Because i took a 5 second look at their website and immediately spotted on the bottom: "Not for sale in the USA"
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When you read "FDA approved" don't immediately think they are talking about the USA FDA. Many other countries have analogous regulating agencies called the FDA, like thailand for example.
Because i took a 5 second look at their website and immediately spotted on the bottom: "Not for sale in the USA"
Very interesting, so question 1: What country's FDA approved it?
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Seriously if it breaks you're f**ked.
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http://www.massdevice.com/ossdsign-wins-fda-nod-3d-printed-cranial-reconstructive-implants/
This suggests us fda
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Seems like a feasible alternative if CT-Bone fails to materialise, as unfortunately seems likely.
All we need to know, which surgeons will be performing these implants (in the midface) within the next year?
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Seems like a feasible alternative if CT-Bone fails to materialise, as unfortunately seems likely.
All we need to know, which surgeons will be performing these implants (in the midface) within the next year?
Far from all we need to know, lol.
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""Retrospective study data presented by OssDsign last year showed that after an average of 9.5 months, 96.7% of patients who received its implants were free from complications that necessitated implant removal.""
Still sounds high risk to me. Wonder how that number compares to other materials.