Johnson & Johnson Medical Phils. recently launched its Cypher Sirolimus-eluting Stent in local hospitals. This is the first and only drug-coated stent approved by the Bureau of Food and Drugs (BFAD) for treatment of narrowed coronary arteries.
An industry first, the Cypher Sirolimus-eluting Stent is a new medical device that addresses one of the most stubborn problems in coronary artery disease treatment – the potential for restenosis.
Restenosis is the re-narrowing of diseased coronary arteries previously treated with balloon angioplasty procedures. It represents a major step forward in medical technology through the integration of a novel acting drug incorporated into a two layer-controlled-release polymer coating on arguably one of the best stent platforms currently available.
"The Cypher Sirolimus-eluting Stent is a breakthrough technology that offers a longer-term and lower-risk solution to CAD compared to other existing treatment options. This is especially important for the Philippines where heart disease, including CAD, is the leading cause of death," says Dr. T. C. Khoo, vice president for medical affairs of Johnson & Johnson Medical Asia-Pacific.
"The results of one of the largest, most extensive medical device clinical development program in Johnson & Johnson, have shown that the Cypher Sirolimus-eluting Stent significantly reduces restenosis rate among CAD patients," Khoo adds.
Worldwide, more than 1.3 million people undergo balloon angioplasty each year, but 25 to 30 percent of the cases result in restenosis, caused by repeat build-up of fatty deposits or the growth of scar tissue at the artery wall that was disturbed by the placement of the stent. It is estimated that 20 percent of 30 percent undergo repeat angioplasty within six months of the initial procedure.
The Cypher Sirolimus-eluting Stent virtually eliminates restenosis through the consistent and controlled release of an active drug to control cell growth, while reducing the risk of blood clot formation. The drug, known as Sirolimus, was selected for its ability to stop cell growth, as opposed to other drugs that kill cells, such as those used to treat cancer – found in other coated stents.
Sirolimus is a naturally occurring antibiotic marketed by Wyeth Pharmaceuticals, a unit of Wyeth, under the name Rapamune, which is used to prevent renal transplant rejection. Johnson & Johnson has entered into an exclusive worldwide license agreement with Wyeth for the delivery of Sirolimus via a stent.
In a landmark clinical trial, known as the RAVEL study involving 238 patients at 19 centers across Europe and Latin America, it was found that the Cypher Sirolimus-eluting Stent placed in patients with CAD dramatically reduced the incidence rate of restenosis to zero percent compared to 26 percent for the conventional, uncoated stent.
The RAVEL study supports results from another earlier pilot study involving 45 patients in Brazil and the Netherlands, where no cases of restenosis were reported for up to two years. The RAVEL data revealed other important indices of the stent’s efficacy.
For more information on balloon angioplasty procedures using the Cypher Sirolimus-eluting Stent, Filipino patients may approach cardiologists in any of the following hospitals: Asian Hospital and Medical Center, Chinese General Hospital, Makati Medical Center, Philippine General Hospital, Philippine Heart Center, St. Luke’s Medical Center, The Medical City and University of Santo Tomas Hospital.