Alright!
So here is the news.
Further biocompatibility testing is needed for all of NuVasive's stainless steel implants, including STRYDE.
Until further notice (Nuvasive quotes July, possibly later) Stryde nail is completely unavailable and all inventory needs to be returned. IN the past few months we were still allowed to use our inventory ,however we are not allowed to implant any further STRYDE at this time.
We thankfully can continue using PRECICE titanium implants , which have a 10 year track record of success and accuracy. We are also continuing lengthening over nails (LON) Lengthening and then Nailing (LATN) and circular fixator lengthenings
On the bright side, a lot of people are still going forward with PRECICE lengthenings which represent a considerable cost saving.
Quote from: Michael J. Assayag, MD on February 13, 2021, 02:48:46 PMAlright!
So here is the news.
Further biocompatibility testing is needed for all of NuVasive's stainless steel implants, including STRYDE.
Until further notice (Nuvasive quotes July, possibly later) Stryde nail is completely unavailable and all inventory needs to be returned. IN the past few months we were still allowed to use our inventory ,however we are not allowed to implant any further STRYDE at this time.
We thankfully can continue using PRECICE titanium implants , which have a 10 year track record of success and accuracy. We are also continuing lengthening over nails (LON) Lengthening and then Nailing (LATN) and circular fixator lengthenings
On the bright side, a lot of people are still going forward with PRECICE lengthenings which represent a considerable cost saving.
Thanks for the news, you definitely are one of doctors who are more involved with patients. Many of us just want to have some certainty and information in order to make a choice about our treatment, so thank you again for the information you provided.
The British NHS... has found problems regarding the Stryde nail. what is puzzling that the American FDA.. did not do the correct checks.. let's see what happens.. as the NHS.. will make sure patients safety.. comes 1st
Hey guys, I got new from Paley and he says that talking about cancer is nonsense, that all of this is due to corrosion at the junction of telescopic ends and it can cause an extra thickening of the bone. He said it happens in half or more of the cases, but he is not concerned because it goes away when removing the rods and it does not cause any serious issues.
Quote from: V21 on February 14, 2021, 08:31:55 AMHey guys, I got new from Paley and he says that talking about cancer is nonsense, that all of this is due to corrosion at the junction of telescopic ends and it can cause an extra thickening of the bone. He said it happens in half or more of the cases, but he is not concerned because it goes away when removing the rods and it does not cause any serious issues.
Let's wait and see what the FDA or NHS will say, not Paley who has an obvious incentive for it to get back in the market.
Quote from: V21 on February 14, 2021, 08:31:55 AMHey guys, I got new from Paley and he says that talking about cancer is nonsense, that all of this is due to corrosion at the junction of telescopic ends and it can cause an extra thickening of the bone. He said it happens in half or more of the cases, but he is not concerned because it goes away when removing the rods and it does not cause any serious issues.
Similarly to LON, is it possible to keep the stryde nail or is it mandatory to remove it?
You should remove it, but you can keep it in if you want. I don't know why you would want to besides not wanting to pay the removal surgery fee. Especially with this whole "unproved biological safety profile" controversy going on now with nuvasive nails.
The timing is not very important, which allows some freedom to choose when to remove it. some people get their nails removed in a year, some in 5 years. Sooner (given full consolidation) is obviously better, as there's just less chance of material going into your body, but it's not like if you don't remove within 2 years you'll get metal poisining or something. It's just over time, material may get absorbed into your body which is no bueno
Quote from: ghkid2021 on February 14, 2021, 04:24:50 PMYou should remove it, but you can keep it in if you want. I don't know why you would want to besides not wanting to pay the removal surgery fee. Especially with this whole "unproved biological safety profile" controversy going on now with nuvasive nails.
The timing is not very important, which allows some freedom to choose when to remove it. some people get their nails removed in a year, some in 5 years. Sooner (given full consolidation) is obviously better, as there's just less chance of material going into your body, but it's not like if you don't remove within 2 years you'll get metal poisining or something. It's just over time, material may get absorbed into your body which is no bueno
Im planning to keep it. Simple titanium rod that many people live with all their lives. I honestly don't mind it and I would also be saving myself from another surgery.
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