Most medical devices get CE mark very quickly, then clinical trials are conducted and data is shared during Wall Street CC's and through the company's webpage, with the disclaimer that the device is not approved for use in the US just yet, and that it's only an investigational device in the US. Just look at the media hype about Cameron Health's leadless ICD. The FDA has not approved it, yet people in the US already know about it, and looking at the Cameron Health website, there is this disclaimer at the bottom:
www.cameronhealth.com "This material is intended for general educational purposes only. The products described are investigational in the United States and can only be sold in those countries where appropriate regulatory agencies have approved these products for commercial release."
"The S-ICD System has received CE Mark and has been commercially available in select geographies, including several major European countries, since 2009. The system has been clinically evaluated in a variety of studies and has been implanted in more than 1,000 patients worldwide. Cameron Health received expedited review status and submitted its PMA application to the U.S. Food and Drug Administration (FDA) in December 2011. Boston Scientific anticipates FDA approval for the S-ICD System in the first half of 2013."
If what you're saying is true, then the FDA should send in the US Marshals with machine guns and shut down Cameron Health and Boston Scientific immediately based on what is presented on their websites and based on all the information that all the doctors in the US know about Cameron Health. I would recommend you contact the FDA immediately and report Cameron Health and Boston Scientific for the violations you just described. If you do not call the FDA and turn in Cameron Health and your beloved Boston Scientific, you're nothing but a coward.
What I am saying is true. They are allowed to market in areas that the product is approved for sale. But let 1 U.S. competitor find 1 piece of material found to be distributed by a Boston Scientific rep to a U.S. physician on an investigational product or feature and the fireworks begin. Boston Scientific would be fined if they started preselling the S-ICD system or a peripheral stent (before it was FDA approved). It is illegal to presell an investigational product or investigational feature in the U.S.
SO now at this point U.S. Boston Scientific peripheral stent sales reps are allowed to go into a physicians offices and begin selling the new stent and to do presentations on it Leave marketing materials behind. THey are not allowed to do that before FDA approval.
So there definitely is a ramp up period for any new product for any company here in the U.S.
Press releases about BSX buying another company and that companies technology is a different matter that is allowed. When it is done for say investment purposes.
Telling a physician why a BSX investigational device is better then the competitions is pre selling and is illegal.
The BSX press release says they plan on getting FDA approval in 2013, and the press release also talks about the technology and benefits to patients and physicians. That sounds like marketing to physicians to me.