Their new 4-lead defibrillator system is taking away huge market share away from BSX. I wonder if this will impact BSX Q4/11 and future revenues significantly, stent revenue gain may not make up.
I agree with your assesment that as of right now more money is flowing into St. Jude then is flowing into BSX and this difference has occurred since 1 Feb. Here is a 6 month chart that shows that point.
In response to your second point. That St. Jude should be scrambling to make a new lead.
I think it is continually underestimated how hard that is to do.
Especially in today's regulatory environment. The FDA is requiring longer and longer studies to get a lead to market. This current regulatory environment has been created by the failures of the Medtronic Sprint Fidelas lead and now the St. Jude Riata lead. FDA let these leads onto the market place with very minimal proof of their long term durability. Hence they are now requiring more proof of long term durability. Any lead that has come out from any comapnay in the past 2 years or so has had a requirement of a 5 year field following. This is very expensive requirement for companies to fund. But the FDA feels it is necessary to avoid the current scenario they find themselves in.
BSX leads are the most durable.... I think this is and has been an under marketed aspect of BSX leads.
BSX has not had an issue the size of Riata for St. Jude or Fidelas from Medtronic but unfortunately BSX is now required to meet this current FDA environment. Basicly BSX is paying a price for something the other companies did. Not right not wrong just is.
FDA regulatory environment is becoming stricter and stricter. The question is when does it become so strict that it starts to stifle innovation here in the U.S.?
I hear ya. I appreciate the well thought out response. I think St.Jude is getting a good uptick from their work in the Afib Electrophysiology market. I am not dispiuting that here in the short term St. Jude is doing well.
It is more about me letting people know that a storm is brewing. St. Jude may make some in roads with some technologies.
Sooner or later they will have to face this lead issue. It is the lead that they use exclusively on ICD and CRT-D implants (that is more then 2/3rds of their CRM revenue come from those 2 style of implants)
The FDA may force their hand in the near future. It could come to that. THey may not be able to sell the Durata lead. They have no other lead to sell if Durata is pulled from the market place. That is why they have no choice but to say this only effects their older style leads. But it is not true. THey will have to move very very fast to not lose significant market share very quickly if it comes to that. THis is a rare scenario developing.
I am surprised St. Jude has tapped danced around this issue as long as they have. God forbid 1 patient die from this issue and it is found out and reported. This will move incredibly fast if that happens.
Ma, you'll be the only MOM here after today, hitting the road, got my MS filled and have to sell here. Wish you guys lots of luck, guess I missed the boat not selling close to $6.20 but still with a profit.
A Tale Of Two St. Jude's
The company's core CRM business continues to struggle. St. Jude has some definite company-specific issues (namely, worries about the quality of its leads),
The above is a Cut and paste from a Seeking Alpha article. The link is below if you wish to read the entire article.
Apparently Seeking alpha has now caught wind of this issue that is current, relevent, and on going with St. Jude's leads. This is a real issue. This could get really really ugly for St. Jude. This issue of their leads has the potential to blow-up and bite St. Jude. I do not want to speak of the scenario that would cause this blow-up. It is in my mind and real. These failures of their lead system is also real.
This article from Seeking Alpha was posted after I made my previous posts. Please read the current link in this post and make your own decisions.
Also please read my previous link to get a greater understanding of this issue in my previous posts. It is a real issue current and developing.
Riata is an old product that hasn't been sold since 2010, the STJ recall will have no impact on their revenues. STJ will continue to take market share away from BSX. BSX's crappy Cognis and Teligen have the set screw and header separation problems which will continue to haunt them.