Release date: 2010-10-18
According to a one-year study published at the Annual Meeting of Cardiovascular Catheterization (TCT) in Washington, DC, a year after the patient used Cook's stent, the rate of arterial blockage was 17%, and those who used blood vessels 33% of patients treated with angioplasty and an old-fashioned stent
A study found that the use of Cook Medical's drug-eluting stents is more effective than standard treatments for patients with blocked thigh arteries. Cook produces medical devices for minimally invasive medical procedures.
According to a one-year study published at the Annual Meeting of Cardiovascular Catheterization (TCT) in Washington, DC, the percentage of arterial reocclusions after a year of use of Cook's stents was 17%. The proportion of patients undergoing angioplasty and an old-fashioned stent was 33%.
The medical device produced by Cook is expected to be the first drug-eluting stent to replace heart bypass surgery in the US market for the treatment of peripheral arterial disease (PAD). According to data from the National Institutes of Health, about 12 million people in the United States suffer from the disease. Cook has filed an approval application for this stent with US regulators, but it will face fierce competition from Abbott and Medtronic in the $3.4 billion drug-coated stent market.
Michael Dake, the chief scientist of the study and a surgeon at the Stanford University Medical Center, said that the use of this stent can reduce the chances of amputation, bypassing, and repeated interventions for patients with PAD.
PAD is a very difficult disease to treat, which occurs when plaques block the artery and interfere with blood flow to the legs and other parts of the body. When a patient walks, he or she often feels awkward and tired at the legs or hips. According to the American Heart Association, these patients are more than four times more likely to have a heart attack and stroke. If the condition is not treated effectively, the patient will be amputated.
Better efficacy
The study, funded by Cook, also compared the drug-coated stents it developed with bare metal stents. The study found that 10% of patients who used Cook's stents had re-stenosis of the arteries, which blocked the flow of blood; the proportion of patients treated with bare metal stents was as high as 27%.
Sanjay Misra, an interventional radiologist at the Mayou Clinic who participated in the study, said in a telephone interview on September 16: "We just want to know if we can introduce a more durable medical procedure. Will keep the blood supply to the legs for a longer period of time."
According to Teri Minor, a senior analyst at market research firm Frost & Sullivan, the market for PAD products is expected to grow 15% this year, from $3.4 billion in 2009 to $3.9 billion.
Opening up a new era
The study, a total of 479 patients, was the first to test for the use of drug-eluting stents to remove blockages from the largest arteries of the thigh. Gregg Stone, director of cardiology at Columbia University Medical Center, said successful trial results It may be a new era for the treatment of this disease.
The use of drug-eluting stents to prevent the accumulation of scar tissue has become commonplace in cardiac surgery. This study is to clarify how much treatment would be used when such stents are used in the thigh.
The most common treatment for leg thrombosis is a medical procedure called balloon angioplasty that inserts a tiny balloon into the leg to remove the blocked blood vessel. In some cases, a bare metal stent (without medication) is placed after angioplasty to prop open the patient's artery.
Due to the repeated movements and pressure generated by the patient while walking, the bare metal stent is easily broken after being placed in the patient's leg.
The stent, called Zilver PTX, produced by Cook, is already on the European market. It does not contain a layer of chemical polymer, which is commonly used in drug-coated stents to place the drug in place. As a result, it can be released slowly. When used in cardiac stents, this chemical polymer may inhibit proper healing of the patient and cause long-term side effects.
Dake said that without this chemical polymer can produce a therapeutic effect, then this removes a factor that may have a negative impact.
In June of this year, Cook submitted a Zilver PTX stent approval application to the US regulatory authorities for the treatment of femoral artery occlusion. The femoral artery is a large blood vessel carrying blood that extends from the bottom of the groin to the thigh.
Abbott and Medtronic have been marketing or are experimenting with stents and expandable drug-coated balloons for the treatment of blocked leg arteries.
Noble Financial Group analyst Jan Wald said the market is currently quite attractive. "We are beginning to see some medical device manufacturers spending more time and energy in this area."
Source: Pharmaceutical Economics
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