Nuvectra?

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anonymous said:
2 questions please
1-how much time the Algeria SCS surgery take, compared to MDT BSX STJM +NVRO. I heard is substantially shorter.
2-Are their MRI friendly SCS's in the pipeline?
Thanks!
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1. Procedure time for SJM/BSX/MDT/NVTR is going to be about the same. They all require lead placement and intraop mapping / lead adjustment /re-mapping not coverage is no good. Nevro has anatomical placement indication so procedure is shorter.
2. The Nuvectra recruiter I spoke with said they expected MRI by "the end of the year" .... in the middle of 2016. Who knows if they'll ever have MRI approval? To my knowledge Nuvectra is MRI contraindicated at this point.
 






anonymous said:
To my knowledge Nuvectra is MRI contraindicated at this point.
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Here's what the labeling that they sent to FDA says.
"Magnetic Resonance Imaging (MRI). As a patient with an Algovita SCS system, you must not be exposed to MRI. The electromagnetic field generated by an MRI may forcefully dislodge your stimulator or leads, damage the stimulator electronics, and induce voltage through the lead that may cause an uncomfortable or jolting sensation or serious injury. The adverse effects listed above may also occur if your SCS system is explanted and any system components or fragments of components remain implanted. The adverse effects listed above may also occur if your SCS system is explanted and any system components or fragments of components remain implanted."
source: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130028c.pdf

Change that c after the PMA number to an a through d and you can see more of their stuff. FDA approval letter is http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130028a.pdf for example.
 
























The submission for MRI has been in for a while and the delay is on the government's end, not Nuvectra's.

One thing to look at is that there are several stages of MRI compatibility (such as 'extremities only' and 'full body') but Nuvectra is so confident that they will get approved for full body so they requested full body compatibility first, rather than work their way up to full body.
 






anonymous said:
Really ??! I heard ONE salesperson has left for reasons unrelated to the company. Care to back up your BS claim??????
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Check your own facts dbag. They had a mass firing 6 months in. Crazy to let do me if the talent go that they did but it's what happens when you empower sales leadership that has no understanding of the pain space or scs
 


















Stan C said:
The submission for MRI has been in for a while and the delay is on the government's end, not Nuvectra's.

One thing to look at is that there are several stages of MRI compatibility (such as 'extremities only' and 'full body') but Nuvectra is so confident that they will get approved for full body so they requested full body compatibility first, rather than work their way up to full body.
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Doubt that MRI submission has been in for a while for SCS. You don't think you would have seen a press release like when they submitted Virtis? Maybe a month or so delayed but no way it's been in "for a while".
 






Nuvectra's presentation at Leerink Partners Global Healthcare Conference they just said that the device will become MRI compatible once the government's tests have been done. They purposely built Algovita with non-ferrous materials so that it would be MRI compatible. They did their own tests and those tests passed.

Also, once they gain full body MRI compatibility, the approval will be retroactive. All devices that have been implanted in patients will automatically become full body MRI compatible.

You don't have to believe me though, just go look at the archived webcast at Leerink Partners.
 






anonymous said:
Nuvectra's presentation at Leerink Partners Global Healthcare Conference they just said that the device will become MRI compatible once the government's tests have been done. They purposely built Algovita with non-ferrous materials so that it would be MRI compatible. They did their own tests and those tests passed.

Also, once they gain full body MRI compatibility, the approval will be retroactive. All devices that have been implanted in patients will automatically become full body MRI compatible.

You don't have to believe me though, just go look at the archived webcast at Leerink Partners.
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We'll see. Purposely limiting non-ferrous material in the IPG is the easiest part of making the device MRI compliant. That is to keep the machine from pulling on the device. The harder part is designing the leads and IPG to not get damaged or heat up during the MRI which is a whole other set of issues.
 
















































anonymous said:
Nuvectra's presentation at Leerink Partners Global Healthcare Conference they just said that the device will become MRI compatible once the government's tests have been done. They purposely built Algovita with non-ferrous materials so that it would be MRI compatible. They did their own tests and those tests passed.
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You don't understand med device in the US. Government doesn't run tests here. This isn't China. FDA evaluates the data you submit. In this case in a supplemental PMA. Also their CEO didn't say shit about waiting on the government.

Drees said Algovita was designed with no ferrous metals and was designed from a biocompatibility standard to be MRI safe. He alluded to some feasibility studies that Nuvectra did confirmed it could be MRI Conditional. He said that they separated the original approval PMA submission from the MRI submission because they didn't want to slow down approval because of MRI. Now that they have clearance for the system and have completed the MRI supplemental PMA testing that they think is necessary for approval, they'll be submitting that supplement "imminently".

anonymous said:
Also, once they gain full body MRI compatibility, the approval will be retroactive. All devices that have been implanted in patients will automatically become full body MRI compatible.
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Because Nuvectra didn't modify anything in their system to "pass" their testing, anything covered in their testing and approved would also be retroactive for what was already implanted (provided it's in the scope of the testing).

Will be interesting to find out what's eventually approved. That webcast was 2/16. Let's say imminently means within the next month. That means we'll know around 9/15 at the latest. The supplemental has a 180-day review period to either approve or reject the supplement. You get questions 60-90 days that you have the rest of the days to address or you're shit out of luck and your supplement gets rejected.

anonymous said:
A You don't have to believe me though, just go look at the archived webcast at Leerink Partners.
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Listen to the presentation. http:// wsw. com/webcast/ leerink28/ nvtr

He also described that all four companies that they compete against (Medtronic, Boston Scientific, Nevro, and St. Jude) all have some level of MRI Conditional capability. For what it's worth, Drees thinks that Medtronic has the best MRI labeling (SureScan). The others have some limitations about what part of the body can be scanned. The claim that they will pursue per Drees is full body.
 






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