The Straits Times Interactive, 13 Nov 2004
S'pore-made stent does well in first trial

Tests on 120 patients show scar tissue is one third that in those with bare metal stents

By: Chang Ai-Lien, Science correspondent

A REVOLUTIONARY stent developed in Singapore , which reduces the risk of infection and scarring in heart patients, has shown promising results in its first clinical trial in Germany and South America.

The results obtained by using the new BioMatrix stent were presented at the world's largest heart conference in the United States.

The trial, involving 120 patients, demonstrated that the new stent worked safely and well, said Mr Lu Yoh Chie, president of Singapore-based medical device company Biosensors International, which developed it.

Among the results: The thickness of scar tissue inside the drug-coated stent was 0.26mm, about one-third that of the 0.74mm seen in patients with bare metal stents.

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

About 2,000 balloon or stent procedures are done yearly here to help unblock arteries, but they can narrow up again - probably due to scar tissue build-up - in a third of all cases.

Drug-coated stents were developed to prevent this problem. The drug Biosensors' product is coated with is mixed into a biodegradable polymer, similar to that used in dissolving sutures.

As a result, unlike the non-biodegradable material used in current drug-coated stents, the polymer disintegrates and is absorbed, instead of remaining in the body as a foreign object.

The drug that coats Biosensors' stent, and is designed to stop the body rejecting the stent, is also fat-soluble. That means it is less likely to be absorbed into the bloodstream, and stays longer in the wall of the blood vessel to do its job.

The findings were presented at the American Heart Association Scientific Sessions in New Orleans on Wednesday, the world's largest gathering of leading cardiologists and other heart specialists.

About 30,000 professionals specialising in basic science research and treatments for heart disease attended the event.

The trial was conducted at the Siegburg Heart Centre and Bruderkrankenhaus Trier, two German heart centres, and at Institute Dante Pazzanese of Cardiology, a medical research hospital located in Sao Paulo , Brazil.

Clinical trials are critical if a company wants to sell a drug or product commercially.

But even before it was tested on humans, the safety and effectiveness of the new stent was shown in tests done on pigs at the National Heart Centre here.

Biosensors plans to start clinical trials on other patients in several hospitals and centres here later this month, said Mr Lu.

This will be part of the next, more widespread, phase of trials, involving more than 100 patients in 40 countries.

The company hopes the results of the existing trial will help get the stent approved for commercial production by the relevant authorities in Europe by the end of next year, and in Asia by early 2006.

Said Dr Mak Koon Hou, a senior consultant at the National Heart Centre, of the stent: 'It has great potential based on these preliminary results.

'If the safety and efficacy can be replicated in large-scale clinical trials, then it will certainly have a role in routine clinical use.'