said Wednesday that early results of a study on its Endeavor drug-coated stent show the device is safe when compared to a traditional uncoated stent. But like the results of a different, but related, study released Tuesday the data didn't impress investors, as the stock slipped.
Medtronic announced the results at a medical conference in Paris, adding that the safety data from this test called Endeavor II will be used in its application to seek European regulators' approval for the device.
Medtronic expects to seek approval in Europe later this year and in the United States in late 2005 for the device used to keep blood flowing through coronary arteries after the vessels have been cleared of fatty deposits. Drug-coated stents are more effective in preventing the reclogging of arteries than are the traditional uncoated -- or bare metal -- stents.
The Paris results are one in a series of clinical trials conducted by Medtronic as it chases two other companies in the rapidly-growing market for drug-coated stents:
Johnson & Johnson
J&J's drug-coated stent, Cypher, has been available in the U.S. for 15 months; Boston Scientific's Taxus has been on the U.S. market since early March. Both companies sell the drug-coated stents overseas. Another large medical device company,
is also working on a drug-coated stent.
Medtronic's announcement Tuesday focused on comparing, among other things, an indicator of safety called a major adverse cardiac event, or MACE. That includes patients who had heart attacks, experienced the need for repeat procedures and ones who died. The test matched patients with other patients receiving the drug-coated stent vs. those getting an uncoated Medtronic stent. The test is 'blinded,' so neither patients nor investigators know the identity of the stents given to patients.
But the results of both groups were favorable enough to convince Medtronic that its drug-coated stent is safe. Both groups' MACE rates "are fully in the expected levels for this type of study," said Dr. Richard Kuntz, co-principal investigator for the study. Kuntz is chief of the division of clinical biometrics at Brigham and Women's Hospital in Boston.
In one group, the MACE rate was 2.9% for 596 patients. In the other group, the MACE rate was 3.5% for 595 patients. Other safety indicators also showed almost identical low scores for the two groups. The patients come from more than 70 hospitals in Europe, the Middle East and Asia.
"As the pivotal trial in our Endeavor clinical program, we are pleased to see the early results have confirmed the safety of the device at the customary 30-day analysis point," said Scott Ward, president of Medtronic's vascular products division.
The Endeavor II's results follow by one day the release of another Endeavor study at the Paris conference. Although Medtronic executives said the results encouraged them to keep their timelines in seeking regulators' approval for the device, some Wall Streets analysts worried about one indicator called 'late loss' -- the degree to which an artery, kept open by a stent, becomes narrower over time.
Tuesday's announcement showed that the late loss after 12 months was 0.58 millimeters compared to the 0.33-millimeter late loss during a four-month period. The 12-month and four-month results cover the same patients.
But the test's principal investigator, Dr. Ian Meredith, said Tuesday that the results demonstrate "the sustained long-term benefit of the Endeavor stent." Noting that the study illustrated low MACE rates and low reclogging rates of arteries, Meredith said the increase in late loss over time "appeared to have no meaningful effect on clinical outcomes, which was positive." Meredith is a medical professor at the Monash Medical Centre in Melbourne, Australia.
Recently, Medtronic's stock was down 82 cents, or 1.7%, to $46.30.