Biosensors’ Heart Stent Matches J&J Rival in Study

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, researchers said.

The news is a boost for Singapore-based Biosensors, which believes its product may avoid some of the problems seen with conventional drug-coated stents–tiny scaffolds used to prop open clogged coronary arteries.

Its BioMatrix product represents a novel approach because it is made with a bioabsorbable polymer.

After nine months, the drug and polymer dissolve completely, leaving patients with bare metal that should 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 followed for nine months, no significant difference was seen in the performance of BioMatrix compared to J&J’s Cypher, Stephan Windecker of Bern University Hospital, Switzerland, told the annual meeting of the European Society of Cardiology.

A total of 9% of patients given the new stent suffered cardiac death, experienced a heart attack or needed reopening of arteries. That compared to 11% of those using Cypher.

Cardiologists said the results were encouraging but they pointed out that the study had followed patients for less than a year and BioMatrix had simply shown ‘non-inferiority’ to an existing drug stent, rather than proving itself better.

Windecker acknowledged longer-term follow-up studies were needed to confirm the theory that BioMatrix could reduce the risk of late blood clots.

Biosensors won approval to sell BioMatrix in Europe at the beginning of this year — a key step in the company’s planned return to profitability. It is also on sale in Asia.

Chief Executive Mike Kleine said the clinical trial was the first of a series of pivotal studies that could make its product a new industry standard.

SOURCE: Forbes.com