from the October 2002 issue
Eluting Stents: a Revolution in Heart Care in the Making
A new approach, holding out great promise in the treatment of heart attacks, the most common cause of death in the Western world, is the use of drug coated stents. Two years ago,Johnson & Johnson, the leader in the field of medicated stents, launched first clinical trials, which included 35 medical centers in Europe and Israel. Two hospitals that participated in Israel, were the Hadassah Medical Center in Jerusalem and Haifa's Rambam Medical Center.
Technically named "eluting stents" they are a step up on bare metal stents, which are widely used to keep clogged arteries open. The problem with bare metal stents is that they fail to avoid reclogging of arteries in up to one third of all cases. The drug coated versions, which give off drugs that help halt cell development, have so far shown much lower rates of reclogging or restenosis. New clinical test data is expected to further confirm the previous results.
The three most prominently mentioned entrants into the medicated stent market are: sirolimus coated stents, rapamycin coated stents, and paclitaxel coated stents. A year ago, at the Congress of the European Society of Cardiology in Stockholm, investigators reported early results from the RAVEL trial, a trial examining the efficacy of a drug coated stent made by Johnson & Johnson. In the follow up period of 210 days the reported results indicated that there was no restenosis in patients receiving the drug coated stent in the RAVEL trial.
Investors and leading contenders for a share of the coated stent market are aware that drug eluting stents have the potential to lift the $2 billion coronary stent market to $4 billion to $5 billion, in a few years after their launch. Most analysts have indicated that the producers should enjoy impressive profit margins as drug eluting stents cost around three times as much as "bare" stents.
Boston Scientific Corp. (NYSE:BSX ), is expected to be close on the heels of Johnson & Johnson. according to analysts. Word is spreading in the industry, that Boston Scientific's 537 patient TAXUS II trial will cut restenosis rates to 1 to 3 percent. This is the first large scale test of the drug Paclitaxel, used by Boston Scientific.
J&J, with its Sirolimus coated Cypher stent, was the first to commercialize one of these lucrative devices in Europe. Guidant Corp. (NYSE:GDT ), the leader in the bare metal stent market, also has a drug coated stent approved in Europe, but it has as yet to launch it commercially due to a legal struggle with Boston Scientific.
Israel's Contribution to the Global Stent Industry
Prof. Hylton Miller, an interventional cardiologist and director of the catheterization unit at Tel Aviv's Sourasky Medical Center pointed out, and as we first wrote in IHTIR in the mid-1990s of the exciting, rapidly developing field of medical stents which emerged in 1996 as an adjunct to conventional balloon angioplasty . It quickly became one of the fastest growing fields in medical devices. Previously, the treatment of choice, for atherosclerotic plaque was balloon angioplasty, with more than 80%of the cases being so treated. However,since the dilated blood vessels became narrowed, cardiologists have added a stent, (a coiled metal spring), inserted in the heart blood vessel after angioplasty which improved overall results.
Israeli medical researchers were in the forefront of medical stent research and development. Medinol Ltd. an Israeli medical device company developed a medical stent in 1996. The US Boston Scientific was quick to see its potential and signed Medinol to a marketing agreement for its Israeli stents.
Additional cardiac and general stents and systems originated from researchers at the Technion, Israel's Institute of Technology. In the late 1990s Medtronic acquired InStent whose product line was designed in Israel. Prof. Rafael Beyar, now dean of Haifa Medical school was the Israeli developer of the stent and holder of the patents.
Reprinted from the Israel High-Tech & Investment Report October 2002
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