Researchers revealed that a new heart stent from Biosensors International made with a biodegradeable drug coating appears as safe and effective as an older industry standard from Johnson & Johnson.

Singapore-based Biosensors believes the product is the answer to some of the problems seen with conventional drug-coated stents that contain tiny scaffolds used to prop open clogged coronary arteries. BioMatrix makes it product using a novel approach -- a bioabsorbable polymer.

The drug and polymer dissolve completely after nine months, leaving patients with bare metal that is thought to be less likely to cause late stent thrombosis -- a rare condition in which blood clots form inside stents a year or more after implantation.

In a clinical study involving 1,700 patients that were followed for nine months, there was no significant difference seen in the performance of BioMatrix compared with J&J's Cypher. This information was reported by Stephan Windecker of Bern University Hospital, Switzerland, at the annual meeting of the European Society of Cardiology.

Although cardiologists feel that the results are encouraging, because the study followed patients for less than a year and BioMatrix had only shown "non-inferiority" to an existing drug stent and not proved better, they feel that longer studies are needed. Ron Waksman of the Washington Hospital Center feels that before anyone becomes over enthused with new-generation drug-eluting stents, new-generation trial designs that will further assess whether or not these new stents are necessarily better - are called for.

Biosensors received approval to sell BioMatrix in Europe at the beginning of 2008. It is also for sale in Asia, but a new clinical trial will be needed before gaining approval in the United States.

More Industry Headlines