I searched the forums to see if anyone had any news recently....I've been following it for quite some time, so here's whats *REALLY* going on.
The maverick hasn't even been up for FDA consideration because of the ongoing lawsuit about the prodisc keel (ludicrous IP case, Synthes is as bad as Amazon and software patents!).
Anyhow, medtronic did not even appeal the injunction on the Maverick, or corrosponding shorter keel A-Mav. They remain barred from US Sales, though medtronic moved manufacturing to Europe some time ago, and since the prodisc patent was only filed in the US (Japan had prior art patents, so I'm not sure how it even was granted here), medtronic is free to manufacture, sell, etc the devices overseas, and seems to be content to do so.
The one bit of hope in the case was they appealed the O-Mav decision as well, since it uses 2 keels, and the US Circuit Court of Appeals ruled in favor of medtronic. Also in that case, for any business owners out there, if you decide you want to put all of your IP in a child company, make sure you set up the paperwork to show the child company grants the parent company an exclusive license to all IP, or that the child company is the only one manufacturing. Medtronic doesn't have to pay any of the damages because of this.
You can read it all yourself at
http://www.cafc.uscourts.gov/images/...rs/09-1538.pdf I have seen nothing from Medtronic nor the FDA about doing anything with the O-Mav, and medtronic claims it was developed specifically for insertion at the L4-L5 area where the aorta branches to avoid the complications that branching creates. I'm not sure if that means they feel comfortable with it at all levels, or just the L4-L5 level. I also don't know exactly what they submitted to the FDA when they revised their study with the shorter keel, was the O-Mav included? If so, getting approval, finally, should be a simple matter.
I guess this is all moot though, since I have been reading on this site that insurance companies have been paying for people to have surgery done in Germany. I myself think I am going to begin investigating this option quite soon. Perhaps by next hockey season, I can be back out on the ice!