Trials of Desi Heart Stent Start in May
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28 March 2011
By Kounteya Sinha
New Delhi, India
First To Be Tried In Large Animals
India’s very own desi drug eluting stent (DES) will go into trials on large animals in May.
According to the schedule, human trials will be started in another year. If the stent proves "effective and safe for human use", India will have its low cost stent in another three years.
DES are coated with medication that is slowly released to help prevent growth of scar tissues in the artery lining. This helps the artery remain smooth and open for good blood flow to the heart. At present, a drug eluting stent costs well over Rs 1.25 lakh while the one being developed under CSIR’s New Millennium Indian Technology Leadership Initiative (NTMLI) may cost as low as Rs 40,000, besides being most advanced in its design.
Speaking to TOI, Dr Ashok Seth from Escorts Heart Research Institute, who is the chief clinical coordinator of the project, said, "We have already created the platform by designing an all new basic metal stent. We will put the drug on that and test it on animals."
According to Dr Seth, president–elect of the cardiology society of India, most of the cost of a stent at present is what companies spend on its research. The making of the stent would not cost more than $100 while patients spend $1,700–$2,500 to get it, Dr Seth said.
He added, "Our stent aims to cost less than one–fifth of what DES costs now. It should be available in three years time after it is tested well, scientifically proven to be safe and effective."
Stents are known to cause restenosis — the formation of new blockages at the site of stent placement due to new tissue growth. This tends to occur during the first 3 to 6 months after the procedure. Dr Seth and his partner DrG S Bhubaneswar from Sri Chitra Tirunal Institute of Medical Sciences (Trivandrum) have now found a way to greatly reduce restenosis.
Dr Bhubaneswar, who is conducting the animal trials, told TOI, "We have coated the stent with titanium nitride. This greatly minimizes chances of restenosis because it is more blood compatible. We will insert it in pigs since their blood clotting profile is very similar to humans. We will remove the stents after three months and six months to study the biocompatibility of the stent and tissue response." Dr Seth said, "Chances of restenosis is about 30% in bare metal stents."