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Wednesday, August 15, 2001



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Story of indigenous stents

M. Somasekhar

AN Indian company has developed a balloon-mounted stent that promises to help heart patients get rid of blockages in their arteries. Priced in the Rs 25,000-35,000 range, the tiny device has also obtained the CE-mark (conforming to European standards). T he CE certification firm.

``The stent is fully indigenous, including the capital machinery used for its fabrication which, in turn, has been manufactured by the parent company, Sahajanand Laser Technology'', said Mr Dhirajlal Katodia, the Chairman.

The balloon-mounted stent, branded the `Millennium Stent' has attracted international attention also, with the company bagging an export order of 400 units from France. The export is worth $2 million, he said.

Sahajanand Vascular has created a separate division for production and research in stents with an investment of Rs 5 crore. ``If technology for fabricating the stent is to be purchased from abroad, it would cost a minimum of Rs 30 crore'', Mr Katodia sai d.

In the growing market for stents in the country, the lead players are multinational companies. A significant percentage of the demand is still met through imports. The device is life-saving and expensive.

Interestingly, under one of the projects promoted by the Society for Biomedical Technology (SBMT), a joint initiative of the Defence research labs and private and public sector organisations, an indigenous version called the `Kalam-Raju' stent was develo ped a couple of years ago.

The low-cost balloon-expandable, stainless steel coil stent, was named after Dr A. P. J. Abdul Kalam, now Principal Scientific Adviser to the Government and one of the key brains behind the SBMT mission, and Dr Soma Raju, a leading cardiologist, now one of the main promoters of the CARE Hospitals and Foundation in Hyderabad.

The project to develop the stent by SBMT was intended to provide a low-cost and quality alternative to imported stents which were prohibitively priced. A separate enterprise called Andhra Cardiology Association was formed to market the product also.

The Kalam-Raju stent, after initial problems with animal trials, was stabilised and was implanted in nearly 100 patients with success. Being low-priced, it also played a key role in bringing the prices of the bare imported versions to the Rs 12-15,000 ra nge, according to Dr Arun Tiwari, Director of the Cardiovascular Technologies Institute (CTI) of CARE.

A stent is a metallic scaffolding used with the precise purpose of preventing arteries from collapsing after they are opened with a balloon (the now popular balloon angioplasty procedure).

The two key aspects of the stent are the material used and the design. While there are three choices for material -- stainless steel, titanium and gold -- the commonly used one is the first. In design, stents come in two forms -- coil or wire and tube.

Both the Kalam-Raju stent and the one fabricated by Sahajanand Vascular use surgical-grade stainless steel, but differ in shape. While the former is a coil or wired the latter system is a slotted tube.

The tube is imported from the US and, with the help of the laser technology available with Sahajanand Laser, it is cut and converted into the fine shape and design as per the requirements.

The standard size of the `millennium stent' is 2.5 x 12 mm. However, depending on the need of the patient, a range of sizes has been fabricated. In the last six months since its introduction in the market, nearly 2,000 stents have been sold, Mr Katodia s aid.

The company has set up two facilities at Surat to produce stents for the export market, and one in Daman to meet the growing demands of the Indian market. Since the launch of the product, MNCs have been forced to cut their product cost by at least 30 per cent, Mr Katodia said.

The company has also used surgical stainless steel with a special polish. The stent is bio-compatible and resistance to thrombosis because of the better stent-to-vessel interface. The Millennium Stent has been subjected to animal trials at the Shree Chit ra Thirunal Hospital in Trivandrum. ``Unorganised clinical trials have been done at the AIIMS, GB Pant and Batra hospitals in New Delhi; the Ahmedabad civil hospital and Sion hospital in Mumbai among others,'' according to Mr Katodia.

In medical history, the first metallic, self-expanding, wire-mesh stent implanted in a human artery was fabricated by Schneider of Germany in 1986 and was named `Wallstent'. Since then, several variants, such as Flexstent, Palmaz-Schatz, Wiktor, Micro, K alam-Raju, Cordis and Multi Link, have hit the market.

The introduction of stents has proved to be an effective method for stopping the possible closure of blood vessel during a routine angioplasty. The mechanical support (scaffolding) of the vessel wall explains the benefits derived after stenting. However, the problem of late restenosis or corrosion of the material used in the stent, or its fracture, have posed new challenges to scientists.

To overcome these complications researchers are concentrating on the development of drug-coated stents and application of radiation at the site of the implant. The biggest challenge, says Dr Tiwari of CTI, is ``to develop `biodegradable' stents''.

In fact, CARE Foundation has, in collaboration with the Institute for Nuclear Medicine and Applied Science (INMAS), New Delhi, and the Bhabha Atomic Research Centre (BARC), Mumbai, initiated a project to test the role of radiation in stopping restenosis.

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