Riata appears to be failing in many countries .. now durata appears to be showing similar problems.
American centres appear to have fracture rates of approx 15% .
will a thin coating called optim save the day ? hard to believe ..
This is the million dollar question, and very hard to answer. We have little data to help. I do think the HRS webinar will calm some implanters, but let's not forget the research report 6-8 weeks ago that stated implanters were spooked and avoiding STJ for the time.
I work in this field so I have a bias, but I will do my best to report my observations un-emotionally. In my city, STJ's ICD market share has been down significantly in the last two months. If I were pressed to give a number I would say 30%. But, to provide balance, their pacer business is un-affected (obviously, huge revenue difference between ICDs and pacers). I also suspect that STJ's share loss in my area is more severe than across the country. There is a wide range of personalities among physicians, and products are choosen for a WIDE range of reasons...
I do believe STJ is still in the thick of this issue, they will have an earnings hit from this, and the CEO better be calm, cool, and collected on the next conference call (if anyone is willing to ask the tough questions). If you require a highly ethical company before investing (I think of Merck), this isn't it.
Two questions that should be asked:
- Back in 2007, when Mdt was getting burned at the stake for their lead issue, Starks made bold statements on how Riata was different (durable, would stand the test of time, backed by the best quality system around). His words are now empty. Why should we believe him now when he says Durata will be fine?
- STJ's only current ICD lead (Durata) was FDA approved through the 510k process, meaning that Durata required limited clinical data because it was designed very similarly to a known predecessor (Riata) with a known, reliable track record. Now that Riata has been recalled, how can physicians, or patients, or the FDA be confident in Durata?
The next conference call will be fascinating. If there is an earnings hit that cannot be masked by the Qtr to Qtr shell game that all companies play, then STJ has to address why customers don't believe them. Admittedly, the actions of STJ's competitors on this issue have been fierce! Is the issue real, or perceived, we honestly don't have the data to know yet, not enough time has passed. This is the turn off for conservative implanters.
At hospitals where implanters are not contractually tied to what they use, STJ has lost share. I do not know what portion of the US is tied into 1-2 year contracts. Let's say that STJ loses 8 - 10%share points in the US ICD market (I think this is reasonable), what portion of overall earnings is this? Please reply with your estimate.
Also, does anyone know when the next Qtr end conference call is?
Great presentation at AHA last night from the country's most noted lead expert on the "pre-recall" Riata situation. It was comforting to know that at least the doctors are taking steps to help the patients since St. Jude just sits around and does NOTHING but to deny the issue for financial greed reasons....
Today we are extracting our 13th Riata due to inside out abrasion which caused the lead to fail. Rep from STJ continues to say there is nothing wrong....disgusting.....FDA, when ever you would like to step in, that would be great!
Publish or post the pictures and evidence to back up your claims. If you're not in a position to get it published, contact someone who is.
Barry Meier at the New York Times published a significant article on Guidant before their 2005-2006 issues. You could contact him. You can also read his article at http://www.nytimes.com/2005/05/24/business/24heart.html?pagewanted=all as an example of what he wrote. You can also contact the FDA if your center's complaints aren't being taken seriously by STJ. Provide them a list of lead models, serial numbers, copies of the documentation of the issues, and then they'll be at STJ writing them 483s.
If you have evidence that the defect rate is as high as you claim it to be, then you and your center need to man-up, come forward publically, and do something about it. St. Jude's published failure rates (http://www.sjmprofessional.com/Resources/product-performance-reports/Product-Performance-Report.aspx) are much lower than you indicate. There are over 150,000 Durata and Riata leads implanted so a bunch of people could be impacted if what you say is true. If you have evidence that they are at a greater risk than reported, it's your duty to raise the flag.
If you don't have evidence and are just repeating what you read off cafepharma, stop alarming patients.
He said there were not any problems due to the optim coating. He's correct, the issue has nothing to do with optim coating. The coating is supposed to eliminate inside out abrasion. It won't. His comment is a play on words.
I work within the industry in a clinical capacity and find it hard to believe that St. Jude has not given any guidance on how to managed the patients. They put out a "Dear Doctor" letter almost a year ago, which they never delivered to the medical community rather they posted it online. This is not only a Riata problem, it is happening in Durata too. No doubt in my mind that they would have called a field action if they had another lead to market. This is truly a business ethics case that they will lose and will cost them DEARLY. We have stopped implanting all STJ leads.
On the contraary, the North part of the PA has grown and increased by 30% this quarter just by the sales of the pacemaker device. I have a feeling that you are a poster from the competitor that trying to inject negative fact to try to bring down the share price. While you said that you have stopped using STJ leads, many new clinics have signed and given more business this quarter.
What failure modes is your facility seeing and how are they being detected?
Is your facility proactively screening patients for lead damage with flouro?
If a damaged lead is detected, is it being capped or explanted?