Medical Device Daily Staff Writer

Cordis (Bridgewater, New Jersey), the stent making arm of Johnson & Johnson (J&J; New Brunswick, New Jersey), is pulling out of the drug-eluting stent (DES) business, as tougher competition and a flat market have eroded sales of these once top products.

On Wednesday, the company said that it would discontinue its Cypher and Cypher Select-drug coated stents by the end of this year. In addition, J&J said that it would stop development of its new stent, the Nevo.

"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," said Seth Fischer, company group chair and worldwide chairman, Cordis. "Cordis has been a leader in establishing many markets including diagnostic and guiding catheters, bare metal and drug-eluting stents, carotid stenting, and treatment of peripheral vascular disease and arrhythmias. These therapies have benefited millions of patients worldwide, saving lives and improving quality of life, and we will continue to bring innovative cardiovascular solutions to patients in the future."

According to J&J, it will eliminate up to 1,000 jobs as it consolidates a research and development team and shuts two manufacturing plants, the San German, Puerto Rico plant where Cypher is made and one in Cashel, Ireland, where Nevo was to be manufactured.

J&J is expected to take a charge of $500 million to $600 million as it restructures its Cordis heart device business.

J&J will continue to make stents for blood vessels outside the heart, particularly in the legs and feet, and is developing one to treat life-threatening aneurysms in the abdominal aorta, a major vessel that distributes blood to arteries below the waist.

"Any decision like this takes time," Sandra Pound, a spokeswoman for J&J told Medical Device Daily. "We're always evaluating the markets that we operate in."

The discontinuation of Nevo comes after the company reported favorable results from the stent in the Res-I clinical trial. In May, the firm released results of the trial at EuroPCR and said that at 12 months showed the Nevo had continued to demonstrate excellent safety and efficacy outcomes compared to Taxus Liberte.

Nevo differs from other DES products because it uses a reservoir (RES) technology, which J&J was able to acquire when it purchased Conor Medsystems (Warren, New Jersey) for $1.4 billion more than four years ago (Medical Device Daily, Feb. 5, 2007).

Also unlike other drug-eluting stents, the company has made claims that stents developed with RES technology will not need to be surface-coated. Instead, each stent will have hundreds of small holes or reservoirs in the stent struts, loaded with a bioresorbable drug-polymer matrix. Over time, the drug polymer matrix is reabsorbed with no polymer left behind.

The company could put the products up for sale or count them off as a loss completely. But Pound, a determination on just what should be done with the products hasn't yet been determined.

"We're pursuing all options for the products," Pound told MDD. We haven't reached a decision yet but we are pursuing all options."

J&J said that the Biosense Webster business will continue to focus on the electrophysiology market while Cordis expands its product portfolio for endovascular and cardiology procedures.

As of late J&J's stents have run up against several challenges. The products that were once solid leaders in the space, have lost market share to stents developed by Abbott Laboratories (Abbott Park, Illinois), Boston Scientific (Natick, Massachusetts) and Medtronic (Minneapolis).

Another blow came when a jury in the District Court for the District of Delaware found that Cordis owed Boston Scientific about $19.5 million for infringing its Jang patent, which covers intellectual property associated with coronary stent technologies (MDD, May 12, 2011).

On top of that, Mass Device is reporting that the U.S. Court of Appeals for the Federal Circuit upheld a U.S. District Court for Minnesota verdict that awarded $22 million in damages to Spectranetics, after a jury found that Cordis infringed a patent covering a method for cutting stents.

These issues coupled with the fact that it can scarcely be considered a secret that stenting procedures (drug-eluting stents in particular) have come under fire in the past few years.

Criticisms of DES arose when Swedish doctors openly questioned the efficacy of DES and said that such procedures have a higher rate of death at the 2006 European Society of Cardiology (ESC; Sophia Antipolis, France) conference (MDD, Sept. 6, 2006).

The reports at the time indicated DES devices may increase the risk of potentially fatal clots in the form of late thrombosis. As a result, the worldwide use of DES went into a sharp decline, with sales going from $5.1 billion in 2005 to $3.9 billion in 2007, according to the Thomson Reuters (New York) agency, Research Markets.

Omar Ford, 404-262-5546;

omar.ford@ahcmedia.com

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