Cordis Announces Plans to Discontinue Cypher Stents, Drop Nevo Development

In a surprise move, Cordis Corporation will stop making its sirolimus-eluting Cypher and Cypher Select stents by the end of 2011, the company said in a press release on June 15, 2011. In addition, Cordis revealed it no longer intends to pursue the development of another sirolimus-eluting stent, the Nevo stent, which showed promising clinical outcomes compared with a conventional paclitaxel-eluting stent just last year at the EuroPCR meeting in Paris, France.

The double announcement effectively represents Cordis’ exit from the DES market.

“The news is definitely surprising,” said Ajay S. Kirtane, MD, SM, of Columbia University Medical Center (New York, NY), in a telephone interview with TCTMD. “From a historical perspective, the whole DES era was ushered in through Cordis’s introduction of the Cypher stent. Now, Cypher has, to a large extent, been supplanted by other stents. From an interventionalists’ perspective, it will be very odd not to have a Cordis DES in that space. But that’s just how evolution works.”

Dr. Kirtane speculated that the decision likely stemmed from expectations of a saturated DES market in the United States. “I think it’s probably partly that it’s hard to maintain a competitive edge with several other devices out there,” he said.

David E. Kandzari, MD, of Piedmont Heart Institute (Atlanta, GA), agreed.

“We have seen a declining market share representation of Cypher in recent years, but . . . what is surprising is not so much that [this product] is disappearing but that a successor to Cypher from the people who were first to market in this space is not going to happen. It appears from what they have said that they are out of the market altogether,” he told TCTMD in a telephone interview. “Cypher was the Coke of sodas, it was the Kleenex of tissues. But [to exit] in such a short time from [its introduction in] 2003 to its fate today, it’s somewhat sad and disappointing.”

Announcement Takes Nevo Co-PI By Surprise

Dr. Kandzari, who served as co-principal investigator of the Nevo program in the United States, said he found out about the company’s decision via news reports.

The Nevo stent is a balloon-expandable cobalt chromium alloy stent containing multiple reservoirs filled with a blend of sirolimus and a bioabsorbable polymer. Absorption of both drug and polymer occurs within about 3 months, leaving only a biologically inert bare-metal platform. The Nevo arose from the Conor stent, which failed to meet its primary endpoint in the COSTAR II trial (Krucoff MW, et al. J Am Coll Cardiol. 2008;51:1543-1552).

Early results for Nevo were considered good following the success of the Res-I trial, which compared it with the Taxus Liberté paclitaxel-eluting stent (Boston Scientific, Natick, MA). Soon after, Nevo II was launched in Europe as a multicenter trial of Nevo vs. the everolimus-eluting Xience V stent (Abbott Vascular, Santa Clara, CA). However, enrollment in Nevo II was suspended in late 2010 because of problems with the balloon catheter.

Still, Dr. Kandzari said the expectation before now was that the Nevo III study would launch in the United States, and investigational sites were already in place.

“It’s challenging for us and our integrity as investigators, because we have to see our colleagues and let them know that we had no insight into this decision,” he said. “I assume that if Nevo is being discontinued that the program is not going forward, but so far no one from the company has contacted me regarding that.”

 

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Source:
Cordis Announces Discontinuation of Nevo Sirolimus-Eluting Coronary Stent [press release]. Bridgewater, NJ: Johnson and Johnson; June 15, 2011. http://www.jnj.com/connect/news/all/cordis-announces-discontinuation-of-nevo-sirolimus-eluting-coronary-stent. Accessed June 15, 2011.

 

• Dr. Kandzari reports research and grant support from Cordis.

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