PETER BENESH: Investor’s Business Daily

The race is on among medical device makers to grab bigger pieces of a shrinking market for cardiovascular stents (stints).
The latest entrant is Medtronic MDT, with Abbott Labs ABT coming up fast on incumbents Boston Scientific BSX and the Cordis unit of Johnson & Johnson JNJ.

But first, that shrinking market.

Much of it can be traced to concerns over the safety of drug-eluting stents, which administer drugs to slow healing and thus prevent scar tissue from re-blocking the artery.

More than 6 million people worldwide have received drug-eluting stents, 3 million in the U.S.

In December, the Food and Drug Administration held hearings on the safety of the stents.

The agency had said it was “aware of recent data suggesting a small but significant increase in the rate of death and myocardial infarction (heart attack) possibly due to stent thrombosis (a blood clot in the stent) in patients.”

After the hearings, the FDA’s experts called on manufacturers to give doctors and patients stronger risk warnings. The panel also recommended that the FDA tell doctors to keep stent patients on aspirin and Plavix for a full year after implantation of a drug-eluting stent.

Plavix is an anti-clotting drug jointly marketed by Bristol-Myers Squibb BMY and Sanofi-Aventis SNY.

Slumping Sales
Since the alarm bells sounded, sales of drug-eluting stents have fallen. They had been $6 billion worldwide. The market now is $4 billion to $5 billion worldwide, says John Capek, Abbott’s executive vice president of medical devices.

Abbott seeks FDA approval for its Xience V drug-eluting stent. It’s playing catch-up with the Cypher stent from Cordis and the Taxus Express2 from Boston Scientific. Those products got FDA approval in 2003 and 2004, respectively.

Abbott will be fourth to market in the U.S. behind new entrant Medtronic.

On Oct. 10, an FDA committee unanimously recommended approval for Medtronic’s Endeavor stent. Twelve days later the European Union approved Medtronic’s Endeavor Resolute stent, a variation of the U.S. model.

Medtronic will start selling the EU-approved stent in 50 countries by the end of the year. It expects FDA approval for the U.S. stent by year-end, says Scott Ward, president of Medtronic’s cardiovascular unit. He predicts a “blockbuster launch.”
“We’re prepared to flow 100,000 units onto the U.S. market within 30 days of approval,” Ward said.

Ward concedes the market is far from certain. Drug-eluting stents once were used in 90% of angioplasty operations. Now they’re used in 60% to 65% of those procedures, Ward says. Some doctors have turned to bare-metal stents.

Still, Ward figures Medtronic can overcome the challenges of selling into a suddenly shaky market. He says the Endeavor stent has shown a lower rate of heart attack and stent thrombosis than competitors.

My Stats Can Beat Your Stats
This is where the industry’s stent wars become statistics wars.

Makers of drug-eluting stents have been running tests to compare their own stents with those of their competitors. The result: a deluge of data that confuses and often conflicts.

Last November, Boston Scientific released a study done in the Netherlands that showed its Taxus drug-eluting stent had a lower rate of re-intervention and equal or lower instances of death or heart attack than the Cypher from J&J’s Cordis unit.

In June, Cordis responded with data of its own from a Danish study. It found that patients on Cordis’ Cypher stent were less likely to need another operation at that same site than patients who got a Taxus stent.

Three weeks ago Abbott said its developmental Xience stent showed a 43% reduction in “major adverse cardiac events” after one year compared with Boston Scientific’s Taxus.

Another study, completed in April 2006 and funded by Cordis, found that inaccurate placement or deployment of stents by surgeons, in the words of the FDA’s Web site, “was strongly correlated with the development of restenosis (re-blockage).”
The study found that drug-eluting stents were poorly installed in two-thirds of cases. In those instances, 5% of patients needed another surgery compared with 2.5% for those with well-placed stents.

Two studies released at a European conference in September compounded the confusion.

One, funded by Sanofi-Aventis and conducted by a consultant for Bristol-Myers Squibb, showed that heart attack victims who got drug-eluting stents in emergency surgery were five times likelier to die after two years than those who got bare-metal stents and Paxil on the side.

The other showed no major difference between patients who got drug-eluting stents and those who got bare metal stents. It found that patients with drug-eluting stents faced a 1% added risk of death.

Meanwhile, Medtronic has begun an 8,800-patient trial pitting its Endeavor against J&J’s Cypher. It will be the largest randomized stent trial, Ward says.

“We think that Endeavor will increase utilization of drug-eluting stents, putting usage into the 70% range or higher once physicians have access to a safer stent,” he said.

Endeavor should be a successful niche product, says analyst Jason Wittes of Leerink Swann, which has done business in the past 12 months with Abbott, Medtronic and Boston Scientific.

“We think it can get 15% of the market,” he said.

The future of stents seems to lie with Abbott, Wittes says. “People look to Abbott for the next generation.”

New Frontier
Abbott is working on a drug-eluting stent that dissolves, unlike metal stents. Called Absorb, it’s now in first trials in humans. Thirty patients signed up for the early trial, with one dropping out after developing a cardiac problem. That’s a low side-effect rate, Capek says.

The biosoluble stent could be on the market in Europe by 2011 and 2012 in the U.S., Capek says.
“If it works as well as metal stents, it could be a replacement product for all the drug-eluting stents we have today,” he said.