As quickly as a patent and a related court injunction expires, another lawsuit is filed in the ongoing case of Abbott Laboratories' (Abbott Park, Illinois) patent for a stent delivery system. It has sought to prevent Medtronic's (Minneapolis) access to the system for eight years.
But the day after the injunction was lifted, Medtronic launched its portfolio of angioplasty products in the U.S. on the Rapid Exchange (RX) Delivery System, including the Endeavor drug-eluting stent (DES), the Driver and MicroDriver bare-metal stents, and the NC (non-compliant) Sprinter balloon catheter systems.
A day later, Abbott filed suit in the U.S. District Court for the Northern District of California asking for a new injunction, Medtronic spokesman Joe McGrath told Medical Device Daily.
At the heart of the intellectual property war is the RX delivery system, popular among physicians because it enables a single operator to deliver angioplasty products, including balloon catheters and stents, through the coronary vasculature. As a short-, single-wire system, it is an alternative to the over-the-wire (OTW) delivery system, a dual-, long-wire system that requires two operators.
"We expect RX to add about two to three share points in the U.S. for the Endeavor drug-eluting stent," McGrath said. "With access to RX, we expect Endeavor's U.S. market share to stabilize in the high teens."
Medtronic said it has abided by the injunction since it was originally issued in 2000 for any RX catheter which infringes claim three of what's now known as the '233 patent.
"RX is the delivery system preferred by three-quarters of U.S. interventional cardiologists," McGrath said. "Medtronic's angioplasty products have previously been available on the OTW delivery system and our proprietary Multi-Exchange (MX) 2 delivery system, a short-, single-wire system. They remain available on these delivery systems."
"RX is a prescription for greater success in cardiac catheterization laboratories nationwide going forward," said Sean Salmon, VP and general manager of the Coronary and Peripheral Vascular business at Medtronic. "Delivering the Endeavor stent on RX makes our flagship DES even more deliverable."
E added, "Given the popularity of RX among physicians, patients with coronary artery disease across the country will soon be much more likely to receive the Endeavor stent, which has demonstrated both long-term safety and durable efficacy in extensive clinical research."
McGrath pointed out that the addition of RX adds no cost to Medtronic's products. "We've been manufacturing the Endeavor stent on RX in Ireland for several years for sale in international markets outside the U.S.," he said.
Medtronic received the CE mark for its Endeavor drug-eluting coronary stent with RX delivery system in 2005.