Angioplasty.Org
Most Popular Angioplasty Web Site
   
Stent Center Stent Center
with support from Medtronic Cardiovascular
Will Medtronic Get An Rx (Rapid Exchange)
For Its Endeavor Stent?

October 23, 2008 (updated) -- Ending a prohibition that has lasted almost a decade, federal court judge D. Lowell Jensen of the Northern District of California ordered yesterday that the injunction preventing Medtronic’s access to the Rapid Exchange (RX) delivery system will end on October 29, 2008.


Paul Yock, MD
    Currently Medtronic (NYSE: MDT) is the only one of the big four stent manufacturers that does not have the Rapid Exchange technology -- a design which allows one operator to perform a stent placement (i.e. "two hands") as opposed to the older configuration of two operators ("four hands"). Abbott got the RX patents (also called the "Yock patents", after stent and IVUS inventor, Dr. Paul Yock of Stanford) when it acquired the vascular business of Guidant in 2006. When Boston Scientific acquired Schneider a decade ago, it gained the monorail rapid exchange technology invented by German cardiologist Tassilo Bonzel. Cordis / Johnson & Johnson licenses the technology, but Medtronic has been frozen out -- until now.

Lack of a rapid exchange system has hampered adoption of the Medtronic Endeavor stent because most cardiologists prefer RX as a simpler, faster and less labor-intensive system. Even so, in May Medtronic reported gaining 20% of the U.S. stent market. Two months later, Abbott's XIENCE stent (also marketed by Boston Scientific as the PROMUS) was approved by the F.D.A. and has rapidly become one of the most popular devices, pushing Medtronic's market share to the low teens. Analysts feel that the availability of a rapid exchange catheter will help Medtronic regain some of those sales.

The Yock patents were scheduled to expire on October 29, but Abbott recently prevailed on the U.S. Patent and Trademark Office to extend the patent -- and last week the Office granted a one-year interim extension. However, this new legal action in effects terminates that restriction and will allow Medtronic to begin manufacturing and distributing rapid exchange balloons and stents in seven days.

Abbott has yet to signal a counter move and Medtronic has stated that it will continue to abide by the injunction until October 29, after which time the company will announce its commercial intent.

 

Reported by Burt Cohen, October 23, 2008 (updated)