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Medtronic Shares Fall on Questions About Stent

Oct 17, 2008 | Parker Waichman Alonso LLP

We have been writing about a number of findings related to stents that were revealed at the Transcatheter Cardiovascular Therapeutics meeting that took place recently in Washington.  Because of the results of one of the studies, entitled Sort Out III, Medronic—a medical device maker—shares fell Thursday.  The study revealed that Medtronic’s new drug-coated stent—the Endeavor—was linked with increased heart attacks and blood clots versus a stent made by its rival, Johnson & Johnson.

Study results included over 2,000 patients and indicated that heart patients who received the Medtronic Endeavor, experienced more heart attacks and blood clots and also required repeat procedures more often than those who were implanted with Johnson & Johnson’ Cypher.  Medtronic spokesman, Joe McGrath, disagreed, “The data are also short-term,” McGrath said in a statement. “At nine months, it’s premature to draw any meaningful conclusions about a difference between Cypher and Endeavor.”  McGrath noted that, “Sort Out III at nine months has no bearing on what matters most to patients with coronary artery disease:  Long-term freedom from adverse events and long-term freedom from repeat procedures.”

In his statement, Dr. Campbell Rogers, chief scientific officer at Johnson & Johnson’s cardiovascular unit, the Cordis Corporation, said, “The breadth of clinical safety and efficacy data and the long-term patient outcomes associated with the Cypher stent are completely unmatched by the competition, and this gap continues to widen.”  Leerink Swann analyst, Rick Wise, said he felt the market had overreacted to the data.  Morgan Stanley analyst David Lewis, saw the downturn as a “modest negative” for Medtronic.  Medtronic shares were off about two percent, to close at $40.01.

Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages to restore blood flow and relieve chest pain

Two studies, one occurring at the annual Transcatheter Cardiovascular Therapeutics conference and another published separately, report that cardiac patients may fare better by receiving fewer artery-opening stents and that stents tend to be used arbitrarily.  Both studies focused on how to treat patients with clogged arteries, a condition known as ischemia, in which patients develop chest pains when blood flow to the heart's muscle is blocked.

Following release of the study data and in an unprecedented move, eight medical companies are collaborating to initiate a $100 million study to understand how to best protect heart patients from rare but dangerous clots following heart stent implantation.  The study is intended to take four years and include 20,000 patients and will be looking at whether heart stent patients can safely be removed from aggressive blood-thinning treatment after one year, or if such patients would be better served by remaining on the medication for at least two and a-half years following implantation with a stent.  Today, guidelines mandate that those patients implanted with drug-coated stents remain on the medication for no less than one year; however, there is some concern about this course of treatment because clots can form in the devices well over a year after they are implanted, with potentially lethal consequences.