20 September 2010
By Kounteya Sinha
New Delhi, India
Imagine a stent that, once implanted, will not only deliver drugs for more than two months, and widen blocked or narrow heart arteries in six months, but also completely dissolve in the body in the span of two years.
India is part of a 100–institute, final stage global trial of the world’s first completely biodegradable drug–delivering stent, which will eventually replace metal ones. Five institutes across India – Escorts Heart Research Institute (Delhi), Apollo (Chennai), Care Hospital (Hyderabad), Madras Medical Mission and SAL Hospital (Ahmedabad) – will use these biodegradable stents on cardiac patients suffering from multiple blockages.
The outcome will be studied for a year, and the patients’ progress will be monitored for the next two years.
Dr Ashok Seth, chairman of Escorts Heart Research Institute, who is the principal investigator in India for the trial, told The Times Of India, "Over 100 institutes from across 30 countries are involved in the trial. The drug controller general has just approved the trial, which we plan to start in another two weeks."
"Treatment of blocked or narrow arteries started with balloon angioplasty, which evolved into bare metal stents, followed by the present–day drug eluting metal stents. Now, we have the fourth revolution in interventional cardiology technology, thanks to the introduction of fully bioresorbabletherapeutic implants," he added.
According to Dr Seth, the Bioresorbable Vascular Scaffold (BVS) technology is "truly revolutionary". Research has found it to be both good and safe as metal stents are mostly made of stainless steel or cobalt, while bioabsorbable stents are made of polylactic acid, which is a proven biocompatible material. For instance, once the artery is opened, the stent will dissolve into carbon dioxide and water – both entities naturally used by the body – and will not cause side effects.
Results from the earlier ABSORB trial demonstrated that Abbott’s bioabsorbable stent successfully treated coronary artery disease, and the treated vessel could expand and contract after two years, indicating that the device had fully absorbed.
"If the bioabsorbable stent performs well in this large final trial with more complex narrowings, it will become the new standard of care for patients with coronary artery disease," Dr Seth said.
Easing The Pain
- India part of a 100–institute, 30–country final stage global trial
- Five institutes across India – Escorts Heart Research Institute (Delhi), Apollo (Chennai), Care Hospital (Hyderabad), Madras Medical Mission and SAL Hospital (Ahmedabad) – will use these stents on cardiac patients suffering from multiple blockages
- Outcome to be studied for a year, and patients’ progress to be monitored for the next two years
- Metal stents are mostly made of stainless steel or cobalt, while bioabsorbable stents are made of polylactic acid, which is a proven biocompatible material