Upon the Food and Drug Administration’s (FDA) approval of the first drug-eluting stent for market use, on April 24, 2003, and official market release on May 5, 2003, Deborah Heart and Lung Center began offering this groundbreaking treatment to its patients. Deborah Heart and Lung Center’s Adult Cardiac Catheterization Laboratory, performed Deborah’s first implantation of the device on May 6.

The patient, a 56-year-old Burlington County man, had undergone triple bypass in September 2002. In April 2003, during a follow-up stress test and resulting catheterization, Deborah cardiologists discovered a coronary lesion requiring intervention. Immediately upon FDA approval, the patient was scheduled for implantation of a drug-eluting stent. The procedure, which lasted under one hour, was successful, and the patient is not expected to experience restenosis.

In the United States each year, 800,000 people undergo coronary angioplasty to open narrowed and/or blocked arteries. More than 80 percent of these patients will receive stents; however, within six to nine months, many of these patients will experience in-stent restenosis due to scar tissue build-up, which could require them to undergo additional interventional or surgical procedures. Drug-eluting stents, when used during angioplasty, offer effective reduction of restenosis by emitting a controlled-release drug for several weeks after the procedure. The drug significantly reduces the chance of in-stent restenosis by limiting smooth muscle cell proliferation inside the stent

In-stent restenosis has posed a challenge to cardiologists because the probability of recurrent restenosis in previously stented patients is in the 40 to 80 percent range. Though some therapies exist to treat in-stent restenosis once it occurs, until now, no methods were available to limit it.

Restenosis is largely caused by uncontrolled smooth muscle cell growth. Drug-eluting stents are equipped with an anti-proliferative, immuno-suppressive drug, which limits the replication of smooth muscle cells in the area of its release. A polymer coating on the stents ensures the controlled release of the drug over a period of three to four weeks, when restenosis is typically initiated. This modality has proven successful; in some clinical trials, drug-eluting stents have boasted in-stent restenosis rates of zero percent in patients with low risk of restenosis, and nine percent restenosis in more complex patients.