Medical Device Daily

The past two years haven't boded well for drug-eluting stents (DES). Continued debate over the safety of the devices has been well-documented and has made headlines constantly in Medical Device Daily. But Cordis (Miami Lakes, Florida) a Johnson & Johnson (New Brunswick, New Jersey) company, is hedging its bets on the Nevo sirolimus-eluting coronary stent in a global head-to-head trial that will compare it to the Xience V everolimus-eluting coronary stent from Abbott (Abbott Park, Illinois)

The company apparently has so much faith in the Nevo and the positive results of the upcoming NEVO II trial that it has reported it will stop production of the Cypher Elite, which 700 patients in the U.S. have been implanted with and are currently enrolled in a clinical trial for the product, which will end in five years.

To make it even more apparent on how much Cordis seems to be backing the device and distancing itself from past models, the company has come up with the slogan, "Transform your thinking about DES."

"We believe Nevo is a significant step forward in stent technology," said Rogers, MD, company CSO and global head of R&D. "It marks a continuation of the Cordis tradition of innovation that began with our introductions of the first bare-metal stent and the first drug-eluting stent."

The NEVO II trial will be a randomized, non-inferiority trial of nearly 2,000 patients with coronary artery disease. Results from the trial will be used to provide long-term data in support of a pre-market approval application with the FDA. The company said it plans to meet soon with regulatory authorities to soon finalize this trial.

Nevo differs from other drug-eluting stents 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 nearly two 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 design also allows drug delivery from a stent with a surface that is 75% bare metal upon insertion and becomes fully bare metal upon drug delivery and polymer bioresorption in three months.

Nevo does share some similarities with the Cypher, in that it will use the same drug, sirolimus, which has now been used in more than 3 million people.

A possible timeline for the device's regulatory approval shows the company pushing for the European CE mark by the end of this year, suggesting a potential launch for the device in 2010. Cordis also said it plans to file for U.S. approval in late 2011.

If proven to be successful, the stent could counter a study that ran in the New England Journal of Medicine last month, which compared coronary-artery bypass graft surgery and drug-luting stent procedures (MDD, Feb. 20, 2009). The study evaluated Boston Scientific's (Natick, Massachusetts) Syntax and showed that those who underwent CABG have better results than those who have stent procedures.

It can scarcely be considered a secret that stenting procedures (drug-eluting stents in particular) have come under fire in the past few years. It all began right about the time 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.

Stent sales for J&J have sunk tremendously. Just in 4Q0, the company said that sales of the Cypher plunged nearly 63% and the price was 6% lower in 4Q07. In 2008, J&J said that its drug-eluting stents fell 23% worldwide and nearly 39% in the U.S.

"We continue to be very enthusiastic about Nevo and believe it represents the most significant advance in the drug-eluting stent market since we launched the Cypher stent," Campbell said. "We also understand that in a rapidly evolving competitive and regulatory environment, it is incumbent on companies to show how a new product compares to a more recently approved product in the category, which is what we are doing with this new trial."

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