For the first time, Israeli company Medinol will sell its stents without Boston Scientific. Medinol is expected to file an application request in the US too.
Sources inform "Globes" that Medinol yesterday received CE Mark certification for NirFlex, its advanced stent.
This is the first time that Medinol has received such approval independently, without Boston Scientific (NYSE: BSX) of the US as a partner. The approval is not confined to the stent itself; it includes the comprehensive system, which includes a stent from the conduction system (a balloon and tube) on which the stent to be inserted into the artery is fitted.
This approval means that Medinol's plan for independent marketing is on schedule, thanks to its solution for the technological problem of developing conduction systems for its stent products.
CE mark certification opens the door for Medinol to a European market estimated in the hundreds of millions of dollars. The US market of about the same size has not yet been opened to the company, since it has yet to file a request for US Food and Drug Administration (FDA) approval for these two products. This request will probably be filed later, although the bad blood between Medinol and Boston Scientific may prove an obstacle to obtaining FDA approval.
No response from Medinol was available as of web posting.
Published by Israel's Business Arena on March 14, 2002