SurModics has licensed its advanced hydrophilic coating technology to Xtent for use in the delivery system of its novel drug-eluting stent (DES) system, designed to reduce the time, complexity and cost of coronary stent procedures.
Xtent is hoping the coating technology will help it keep ahead of the game in the rapidly evolving DES market, estimated to be worth $5.5bn (€4.3bn) and growing.
"In the highly dynamic drug-eluting stent market, deliverability is emerging as a key differentiator, especially in the treatment of complex coronary disease, which is the largest and fastest growing portion of the market," said Greg Casciaro, Xtent president and CEO.
Drug eluting stents have revolutionised the treatment of coronary artery disease, with close to 100 per cent penetration in the US, and 50-60 per cent in the UK.
They have made it feasible for cardiologists to treat increasingly complex lesions in more difficult patient populations such as diabetics.
Currently, however, patients with long, diffuse lesions or blockages in more than one artery require multiple stent placements and there is a need for new technology that will allow the navigation and delivery of stents through patient vasculature.
Xtent's new DES takes a less invasive approach than currently available systems as it allows the physician to precisely customize the stent to fit the lesion length and to treat lesions in multiple arteries with a single catheterization, said the company.
"In this way it is capable of delivering multiple custom-length stents to treat lesions in numerous vessels with a single procedure and improves stent deliverability while reducing procedure complexity, time and cost."
Xtent recently successfully completed a Phase I clinical trial and as a result the company is pushing forward with the product, initiating a Phase II trial in multiple European centres.
Commenting on the product, Bernard De Bruyne, co-director at the Cardiovascular Center in Aalst, Belgium, said: "The Xtent DES catheter is very deliverable even in tortuous anatomy."
"The outer sheath on the catheter not only protects the stent, but it has a coating that is extremely slippery. The combination of flexibility, pushability and highly lubricious coating makes the overall delivery of the catheter quite competitive."
Xtent expects to gain marketing approval for the new DES system in Europe during 2007 and in the United States in 2009.