Unichem Laboratories Ltd.
The Food and Drug Administration (FDA) approved a drug-eluting stent – Zilver PTX for treatment of peripheral arterial disease of femoral arteries. Zilver PTX is designed and manufactured by Bloomington-based Cook Inc.
The stent is an empty mesh tube that is employed to clear the clogged arteries and to open for blood circulation. The stent is inserted by surgical interventional procedure. An arterial stent is coated with controlled-release, clot-busting drugs to prevent arteriosclerosis.
According to FDA press release statement, PAD can occur due to deposition of atherosclerotic plaques in arteria intima that affects blood flow. Symptoms of PAD include gangrene and persistent leg pain.
479 patients were recruited to determine the safety and efficacy of the stent and the patients were monitored over a period of one year. At the end of the study period, researchers found femoral arteries without clogging in 83% of the new stent implanted patients. However, only 33% of normalcy is reported in the control group.
The stent is contraindicated in gestation and breast-feeding women or women who opt to become pregnant within 5 years. The commonly reported adverse event of Zilver PTX is recurrence of PAD in the affected artery if stent is removed.
The FDA directed the manufacturer to conduct five-year post approval clinical trials with minimum participants of 900 participants with implanted stent.