Last week, Medinol received CE-mark approval for introducing its pre-mounted Nirflex systems across Europe.
Israeli stent designer and manufacturer Medinol announced on Monday that it had received US Federal Drug Administration (FDA) approval to begin recruitment for its Investigational Device Exemption (IDE) study in the US for its next generation Nirflex stent. Last week, Medinol received CE-mark approval for introducing its pre-mounted Nirflex systems across Europe.
Medinol said it was pleased to note that the FDA accepted the Nirflex as a continuation of the company's Nir stent, whose clinical data is owned by Medinol, thereby approving a simpler study of equivalence between the Nirflex and the Nir. This study will begin in 12 US leading medical centers in May 2002.
Medinol CEO Dr. Judith Richter commented that "FDA approval of clinical studies on the Nirflex marks another important milestone in Medinol's charge back into the forefront of the global interventional cardiology market. We are very pleased with the momentum we are building towards delivering the profound benefits of the Nir family of stents to cardiac patients and cardiologists around the world."
According to the company, the Nirflex stent combines extreme flexibility, before and after deployment, with the optimal scaffolding traditionally associated with the Nir family of stents. Medinol said that the Nirflex was developed by Medinol and was the company's patented and exclusive property.
Medinol also announced that it was working to bring to market a number of other specialized systems that have long completed development and have been presented in Europe.
Published by Israel's Business Arena on March 19, 2002