The market for drug eluting stents at 2.25mm in size just got a little bit bigger. Cordis (Miami Lakes, Florida) a Johnson & Johnson (New Brunswick, New Jersey) company has reportedly entered the fray with the recent launch of its 2.25mm Cypher Sirolimus-eluting Coronary Stent. For months now the market has been solely occupied by Boston Scientifics' (Natick, Massachusetts) Taxus Libert Atom (Medical Device Daily, May 28, 2009).
"Certainly now it becomes a two market product," Christopher Allman, a spokesman for Cordis told Medical Device Daily. "We'll be competing to gain market share."
The approval is based on the results of four studies including, in part, the clinical results of the SES-SMART trial. This trial was a randomized comparison of the 2.25 mm Cypher Stent to bare metal stents in the reduction of restenosis in small coronary arteries. At two years of follow up, patients receiving the Cypher Stent had significantly better clinical outcomes than those patients receiving a bare metal stent. In fact, use of the Cypher Stent led to an 82% reduction in restenosis compared to a bare metal stent (p<0.05) at six months.
The smaller size reduces the chance of restenosis, a painful side effect that seems to occur after some DES are implanted.
"Small vessel disease is quite complex and difficult to treat, Allman told MDD. This approval gives us a means to address this problem. We knew when we were developing the Cypher that eventually a smaller size would be necessary."
The stent is available now and has already been approved for use outside the U.S. But even still the company could have a ways to go to regain market share from Boston Sci, which has had its 2.25mm DES out since May.
The key for success over Boston Scientific comes from the clinical trial results of the stent, according to the company.
Cordis said that its stent has outperformed Boston Sci's Taxus in numerous clinical trials. The company said that In the ISAR-SMART 3 trial, for example, patients treated with the CYPHER Stent had 55% less late loss after eight months than patients receiving a TAXUS Stent (p=0.001). Data from the RESEARCH and T-SEARCH registries showed that patients treated with the 2.25 mm CYPHER Stent had a 65% lower incidence of death or myocardial infarction (MI) than patients treated with a 2.25 mm Taxus Stent (p=0.04).
In other news, the company along with Wyeth (Madison, New Jersey) reported that they were suing Abbott (Abbott Park, Illinois) and Boston Scientific alleging infringement of a coatings patent for coronary stents. The lawsuit was filed in U.S. District Court for New Jersey on Sept. 22. It alleges that Abbott and Boston Scientific infringe the patent with every sale of the Xience V and Promus stents in the U.S.
Cordis and Wyeth are looking for judgment affirming the infringement, an injunction against sales of both stent models in the U.S. and unspecified damages and interest.
The Cypher stent competes with Abbott's Xience V everolimus-eluting stent, which Boston Scientific sells under a private-label agreement as the Promus stent.
This is but the latest round in a plethora of cases between stent makers.
Cordis recently won an appeal of a patent lawsuit filed against the firm in 2003 by Boston Scientific when the Massachusetts company alleged that the design of Cordis' cypher stent infringed on two patents one of which dealt with a dual-layer coating for drug elution and the latter with the geometry of the stent's struts (MDD, January 30, 2009).
Collectively the companies are involved in dozens of cases regarding patent infringement. Cordis is involved in 10 lawsuits filed between Jan. 1, 2004, and Aug. 13, 2008. There are more than 20 lawsuits involving Medtronic (Minneapolis) over the same period of time, all of which deal with patents, while Boston Scientific (Natick, Massachusetts), is also named as part of more than 20 patent lawsuits in that time. Of that number for Boston Scientific, eight were filed in the first eight months of 2008, according to Justia.com, a database of legal news.
Omar Ford, 404-262-5546;