The Straits Times, 29 March 2004
Heart patient here to get revolutionary stent

By: Chang Ai-Lien, Science correspondent

A REVOLUTIONARY made-in-Singapore stent that reduces the risk of infection and scarring in heart patients, is being inserted into its first Singapore patient today.

The device, which has had promising results in clinical trials in Germany, will be implanted into a patient at the National Heart Centre here by a leading German cardiologist.

A stent is a tiny metallic tube used to keep open an artery that has been cleared of its fat and cholesterol.

This one, which is coated with a drug to prevent scarring, is special because the drug has been mixed into a biodegradable polymer, similar to that used in dissolving sutures.

So, rather than remaining in the body as a foreign object, the polymer disintegrates and is absorbed.

This is different from current drug-coated stents on the market, which use non-biodegradable material.

The drug covering the stent, developed by medical device company Biosensors International, is called Biolimus, and is an immuno-suppressant to stop the body rejecting the stent.

The body's attempts to reject stents cause scarring, which would narrow the artery again.

Because it is fat-soluble, the drug could stay in the blood vessel wall longer and work better, which could reduce scarring.

About 2,000 balloon/stent procedures are done yearly here to help unblock arteries, and about a third of stent patients experience a re-narrowing of the arteries, probably from scar tissue build-up.

Drug-coated stents were developed to prevent this problem.

The new stent has also been tested in animals at the National Heart Centre, and the possibility of a further clinical trial here is being discussed.

Speaking about the trial involving 120 patients at Germany's Siegburg Heart Centre, Professor Eberhard Grube, the centre's chief of cardiology and the trial's principal investigator, said results are very promising.

'The initial six-month follow-up of patients has shown excellent healing of the vessels involved,' said Prof Grube, who will be performing today's procedure.

It will be watched live by experts attending the 13th Singapore Live Interventions in Vascular Endotherapy Course, an annual cardiology convention organised by the National Heart Centre.

He said the plan is to have the stent approved by the European authorities next year.

A senior consultant at the National Heart Centre and its director of clinical trials, Dr Mak Koon Hou, said if the device works as well as trials have indicated, it could help lower the price of drug-coated stents, benefiting patients.

Biosensors, which was formed in 1990, has offices all over the world, including the United States, Japan and China; but its president Lu Yoh Chie chose to make Singapore its worldwide headquarters.

'Singapore is the gateway to Asia, which offers an explosive growth of opportunities for health-care products, particularly cardiology, with the rise of coronary heart disease in this region.

'Singapore's strong medical infrastructure and the push towards life sciences is an added advantage,' he told The Straits Times.

A similar stent by the company was so promising that the rights to use its clinical trial results were bought by US-based medical device giant Guidant Corporation for more than US$20 million (S$34 million).

Clinical trial results are critical if a company wants to commercialise a product.

Biosensors plans to improve its drug-coated stents and develop a completely dissolvable one, said Mr Loh.