Cordis Quits Stent Business, Dropping Cypher, Nevo DES

Shelley Wood

June 16, 2011

June 15, 2011 (Bridgewater, New Jersey) — The first company to bring a drug-eluting stent (DES) to worldwide markets is not only dropping development of its novel reservoir-based DES design, it is going to be getting out of the coronary stent business altogether [1].

Cordis/Johnson & Johnson made the announcement in a press release earlier this morning, reportedly surprising some of the investigators for the US-based NEVO III trial, led by Dr David Kandzari (Piedmont Heart Institute, Atlanta, GA) and Dr Daniel Simon (University Hospitals Case Medical Center, Cleveland, OH). According to the release, Cordis will stop making the once-groundbreaking Cypher sirolimus-eluting stent by the end of 2011 and is abandoning development plans for its Nevo sirolimus-eluting stent.

Kandzari told heartwire he found out about the news "from Wall Street," while Simon said he received a call from Cordis executive Campbell Rogers early Wednesday.

Cypher was really the Coke of the sodas, the name brand synonymous with drug-eluting stents.

The announcement marks the end of an era, of sorts: the Cypher was the first drug-eluting stent ever to prove itself in clinical trials as superior to a bare-metal stent for reducing restenosis--earning a standing ovation at the 2001 European Society of Cardiology meeting, as reported by heartwire . The Nevo stent, meanwhile, the sirolimus-loaded version of the failed Conor stent, was supposed to be an answer to the indiscriminate drug delivery offered by existing DES, because its novel design used little reservoirs filled with sirolimus and polymer, rather than coating the entire stent with the drug.

The Nevo, however, has faced a number of hurdles--the NEVO II study was suspended last year due problems with the stent delivery catheter, and according to Kandzari, NEVO III has never gotten off the ground. Moreover, there has been almost no news on how any studies with the Nevo are progressing.

When Cordis first bought the technology, there was real promise, Kandzari said in an interview with heartwire . The reconfigured stent "seemed to have overcome many of the problems of the Conor program, and the [RES-1] trial, while small, showed trends favoring not only efficacy but safety with the Nevo stent. But the company has been so secretive about whether there has been any progress made."

Then, in February, Cordis announced it was laying off the bulk of its US coronary stent sales force. "In hindsight, looking back, you have to wonder if today's announcement wasn't planned internally by Cordis several months back," Kandzari observed.

Simon, meanwhile, said he was disappointed, commenting that he had been "excited" by the Nevo technology and thought it was a "real technical advance." But he also pointed out that stents have become a "commodity" technology, with the price dropping from over $3000 a stent to around $1400.

"That's only going south from here, so it's pretty easy to understand why Cordis would make this business decision, not wanting to spend $500 million dollars for an uncertain return. . . . But Cordis has always been on the forefront of innovation, [and it's clear] they are going into the next frontier."

The Cypher's one-time dominance has been eclipsed by the Xience/Promus everolimus-eluting devices, as well as the rise of other platforms, using other drugs. But as Simon observed, the timing of the Cypher's demise is "ironic," coming as it does on the heels of trial results like EXCELLENT and SORT-OUT 4, which have suggested equivalency between the Cypher and Xience stents. And while he admits the newer stents have the advantage of being much more deliverable, he maintains there are still circumstances in which having the Cypher on hand would be a welcome option.

Explaining the company's decision, Cordis group chair and worldwide chair Seth Fischer stated, "Due to evolving market dynamics in the drug-eluting stent business, we see greater opportunities to benefit patients and grow our business in other areas of the cardiovascular-device market."

Those "other" areas include those currently the focus of Johnson & Johnson's Cordis and Biosense Webster businesses: namely, electrophysiology mapping/navigation systems and products for "lower-extremity disease," abdominal aortic aneurysm disease, and vascular-closure devices.

Still, for those at the heart of the DES world, riding the undulating fortunes of these devices over the past decade, the departure of Cordis from the coronary stent arena is a head-shaker. "Cypher was really the Coke of the sodas, the name brand synonymous with drug-eluting stents," Kandzari said. "To think this has happened from 2003 to the present: it's hard to find words for it."