The encyclopedia · Product & Design · Product decision · 2002–2003
Cordis' CYPHER stent cut restenosis from 26.6% to 0% and won FDA approval
A polymer stent releases sirolimus at the artery wall, stopping the re-blocking of a quarter of bare stents; CYPHER was the first drug-eluting stent.
Cordis
the move
Stenting solved acute vessel collapse, but the vessel's healing response grew neointimal scar tissue that re-blocked the artery. In the RAVEL trial, 26.6 percent of patients with bare-metal stents had restenosis within six months.
Cordis' CYPHER stent added a polymer coating that elutes sirolimus, an anti-proliferative drug, over weeks. RAVEL randomized 238 patients at 19 centers: late luminal loss was 0.01 mm versus 0.80 mm, restenosis 0 percent versus 26.6 percent, and one-year major cardiac events 5.8 percent versus 28.8 percent.
The U.S. FDA approved CYPHER (PMA P020026) on April 24, 2003 — the first drug-eluting stent in the country — and the category transformed interventional cardiology.
why it works
- The drug acts at the injury site at therapeutic concentration without systemic side effects.
- Polymer release timing matches the weeks of neointimal growth.
- A dramatic randomized result made adoption fast and evidence-based.
- First-mover approval created a premium-price category.
what transfers
When the problem is timing — injury, then over-repair — deliver the treatment at the site and schedule it to the biology: local, timed release beats systemic dosing.
what came after
Cypher's success drew competitors such as Taxus, and later safety questions around late stent thrombosis tempered enthusiasm, but drug-eluting stents became the default for coronary stenting worldwide.
references
- FDA PMA P020026 — CYPHER Sirolimus-Eluting Coronary Stent
- A Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent (NEJM, 2002)
- FDA Summary of Safety and Effectiveness — CYPHER (P020026)
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