Things are starting to heat up in the vascular-medical-device arena. This time, the source of the conflict isn't the device itself, but the doctor-favored mechanism for its delivery.
The delivery of balloon catheters and stents used to clean out and keep open veins and arteries comes in two basic flavors -- over-the-wire and rapid-exchange. The name refers to where the guide wire is during the delivery process. Abbott Labs'
Privately held AngioScore sent a citizen's petition to the Food and Drug Administration arguing that Abbott didn't deserve an extension under the Hatch-Waxman Act. The act allows drugmakers and medical device companies to recoup some of the time that their patent was in effect, but unusable, because the FDA hadn't yet approved the drug or device.
Essentially, AngioScore argues that Abbott can't ask for a patent extension based on its new Xience V drug-eluting stent, which uses the technology, because the rapid-exchange technology was already used in an approved device back in 2003 and 2004. In other words, Abbott missed its chance.
AngioScore's not the only company that would benefit if the patent extension failed. Medtronic
On the other hand, fellow drug-eluting stent maker Boston Scientific
Sit back and relax, Fools -- we're likely to have a few more rapid exchanges before this fracas is finally settled.
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