Medtronic, a US heart devices maker, yesterday unveiled new data which it says highlight the equivalence of its new drug-eluting stent Endeavour to Johnson & Johnson’s big-selling offering, Cypher. Endeavour is now on track to reach the world’s largest pharmaceutical market, the USA, next year, where it is expected to become the third offering available to heart disease patients.
Results from the pooled clinical data presented at this week’s American College of Cardiology meeting show that Endeavour was safe and effective in 1,300 patients with coronary artery disease who were enrolled across four trials; there were no incidences of late stent thrombosis (blood clots) at more than 30 days post implant and an overall thrombosis rate of just 0.3%.
So confident is Medtronic in its stent that it is prepared to put its money where its mouth is and go head-to-head against the big boys in the field – Johnson & Johnson and Boston Scientific. Longer-term results from the Endeavour III study showed the safety and clinical profile of its stent was maintained after one year, with Endeavour showing equivalence to Cypher on all endpoints. For example, target vessel failure rates for the two stents at 12 months were 13.2% for Endeavor and 11.8% for Cypher (p = 0.87), compared with 12.0% and 11.5% respectively at nine months (p = 1.00).
And Medtronic has also enrolled 1,000 patients into a trial comparing Endeavour with Boston Scientific’s Taxus – with the primary endpoint being target vessel failure. It expects to complete the 1,500-patient sign-up by the spring, although there are suggestions in the market that this could be somewhat of a tall order.
However, the news certainly marks a positive for Medtronic. Last year it took a knocking after Endeavour failed to demonstrate equivalence against Cypher on a measure known as late-loss (0.34mm versus 0.13mm for Cypher) – which indicates whether a blood vessel is likely to narrow. However, at the time, Medtronic stressed that late loss is a surrogate marker and that other clinical endpoints are of greater importance.
The Endeavour system has already been granted approval in Europe and has been launched in more than 85 countries around the world. And analysts are reportedly pleased with Medtronic’s efforts to spotlight Endeavour’s strong safety profile, suggesting this could become a key selling point in the company’s marketing strategy upon launch.