THE WEXFORD-based Clearstream Technologies, which develops and manufactures medical devices such as catheters and stents that are used in procedures such as angioplasty, will carry out a major international trial of its new stent at St James’s Hospital in Dublin. The company has already received approval in Europe for its intrepide drug-eluting stent (DES).
A drug-eluting stent is a coronary stent placed into narrowed, diseased coronary arteries that slowly releases a drug to prevent fibrosis that, together with clots, could otherwise block the stented artery, a process called restenosis.
In a small number of cases, patients suffer late stent thrombosis or clotting of the blood when they are eventually taken off the drug regime.
However, during its safety trials it emerged that Clearstream’s intrepide stent prevented late stent thrombosis and the company is now conducting a major trial involving 1,000 patients which will be started in St James’s Hospital under Dr Niall Mulvihill.
“We believe we have a product that can solve a problem,” said Andy Jones, managing director of Clearstream. “The problem we believe it prevents is late stent thrombosis. We demonstrated it in our safety trials and now we need a much larger cohort of patients to prove it statistically.”
If successful, it will represent a huge opportunity for the firm, said Mr Jones who described it as an Irish success story.
“This product is designed and manufactured in Ireland,” he said.
“Drug eluting stents represent about 65 per cent of the worldwide interventional cardiology market. This jumps us to a point where we are addressing a much larger segment of the market than we were before.”