Nuvectra?

[anonymous]

Anyone know what the story is with Nuvectra and how it stands up to SJM/BSX/MDT? What is their selling point? Do they have a unique feature the others don't have?

 

[anonymous]

Only know it's former st Jude neuro group at the helm. I've heard they have a lot of people looking to leave because of VP and President. Product seems to also be lacking compared to other more contemporary platforms and technology. Good luck

 

[anonymous]

Actually the complete opposite but good try.

 

[anonymous]

'me two' piece of shit product trying to buy into the market. $200k first year guarantee is nice. After that though...best thing would be have something lined up when that runs out.

 

[anonymous]

Zero traction in my market.

 

[anonymous]

Zero traction in my market.

I have not seen or heard of them in my area yet. Sounds like it is a dated system and I think they may have already had product issues. Competitive space and tough to compete in unless your offering something really unique.

 

[anonymous]

You think they'll stay afloat?

 

[anonymous]

You think they'll stay afloat?

Helll no

 

[anonymous]

Maybe Matty size 6 can take some docs to a few strip clubs and buy some biz...if he doesn't f up his expense report again. Sunshine act don't lie

 

[anonymous]

Keep underestimating Scott Drees and Co. We like that!

 

[anonymous]

Keep underestimating Scott Drees and Co. We like that![/QUOTE

Sounds like you have an insider's view of things. In your opinion, what was Nuvectra's biggest success in 2016?

 

[anonymous]

Did nuvectra already have a recall on their leads?

 

[anonymous]

Class 2 Device Recall Algovita Spinal Cord Stimulation (SCS) System


Date Initiated by Firm October 11, 2016
Create Date December 17, 2016
Recall Status1 Open3, Classified
Recall Number Z-0781-2017
Recall Event ID 75459
PMA Number P130028
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit;
Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit;
Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit;
Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit.
Model Number (s) 112x-xx (CT), 108x-xx(T).
These are part of the Algovita Spinal Cord Stimulation System.

The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patients spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patients brain. The stimulators are rechargeable, and the frequency of recharging is dependent on
individual patients use of the system.
Code Information all serial numbers
Recalling Firm/
Manufacturer Nuvectra
10675 Naples St NE
Blaine MN 55449-5802
For Additional Information Contact Kathy Jo Fahery
763-951-8219
Manufacturer Reason
for Recall Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System. It has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.
FDA Determined
Cause 2 Nonconforming Material/Component
Action Nuvectra field sales associate or contracted distributor were sent a Nuvectra Urgent Field Safety Notice (Field Action Number: 2016-03) on 10/11/2016 via Fed-Ex. The letter provided background information, described the problem, & the product involved in the recall. The letter listed the potential clinical implications, rate of occurrence, recommendations and mitigations and action needed. Provided consignees with notices for them to deliver to physicians as well as Response forms for them and the physician. For questions contact Kathy Jo Fahery +01.763.951.8219.
Quantity in Commerce 406 US, 985 OUS

 

[anonymous]

Class 2 Device Recall Algovita Spinal Cord Stimulation (SCS) System

Date Initiated by Firm October 11, 2016
Create Date December 17, 2016
Recall Status1 Open3, Classified
Recall Number Z-0781-2017
Recall Event ID 75459
PMA Number P130028
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit;
Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit;
Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit;
Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit.
Model Number (s) 112x-xx (CT), 108x-xx(T).
These are part of the Algovita Spinal Cord Stimulation System.

The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patients spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patients brain. The stimulators are rechargeable, and the frequency of recharging is dependent on
individual patients use of the system.
Code Information all serial numbers
Recalling Firm/
Manufacturer Nuvectra
10675 Naples St NE
Blaine MN 55449-5802
For Additional Information Contact Kathy Jo Fahery
763-951-8219
Manufacturer Reason
for Recall Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System. It has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.
FDA Determined
Cause 2 Nonconforming Material/Component
Action Nuvectra field sales associate or contracted distributor were sent a Nuvectra Urgent Field Safety Notice (Field Action Number: 2016-03) on 10/11/2016 via Fed-Ex. The letter provided background information, described the problem, & the product involved in the recall. The letter listed the potential clinical implications, rate of occurrence, recommendations and mitigations and action needed. Provided consignees with notices for them to deliver to physicians as well as Response forms for them and the physician. For questions contact Kathy Jo Fahery +01.763.951.8219.

 

[anonymous]

All lies

 

[anonymous]

All lies

How so?

 

[anonymous]

I'm not sure about lies, but the recall you posted is a bit misleading.

The truth is that two patients did have issues with the leads overextending. The recall affected very few devices and was immediately fixed. There are no bad leads in any patients and there were controls implemented so that this specific manufacturing problem wouldn't happen again. All this was addressed in Nuvectra's Q3 Earnings call. In fact I believe NVTR management made the recall public and fixed the issue before the government even made it public.

 

[anonymous]

I'm not sure about lies, but the recall you posted is a bit misleading.

The truth is that two patients did have issues with the leads overextending. The recall affected very few devices and was immediately fixed. There are no bad leads in any patients and there were controls implemented so that this specific manufacturing problem wouldn't happen again. All this was addressed in Nuvectra's Q3 Earnings call. In fact I believe NVTR management made the recall public and fixed the issue before the government even made it public.

The same earnings call where they reported a whopping $3.8 million in revenue.

 

[anonymous]

The same earnings call where they reported a whopping $3.8 million in revenue.

Not great but headed in the right direction

 

[anonymous]

I'm not sure about lies, but the recall you posted is a bit misleading.

The truth is that two patients did have issues with the leads overextending. The recall affected very few devices and was immediately fixed. There are no bad leads in any patients and there were controls implemented so that this specific manufacturing problem wouldn't happen again. All this was addressed in Nuvectra's Q3 Earnings call. In fact I believe NVTR management made the recall public and fixed the issue before the government even made it public.

2 out of how many? This company just opened its doors.