Medical device start-up InspireMD Ltd. has obtained EU CE Mark certification for its proprietary stent. The company said that the certification will enable it to market the stent in certain countries Asia, Latin America, and Africa, where marketing approval corresponds with EU approval.
The company has developed a family of stents with expandable, fishnet style, micron-level polymer sleeve wraps that seamlessly prevent embolic showers without affecting drug delivery. The sleeve keeps the stent in place while reducing the cuts in the arterial wall.
InspireMD CEO Ofir Paz said that the company provides doctors with a comprehensive defense against embolic showers by combining protective means as an integral part of the stent, and that catheterization is unaffected by the application of aids.
InspireMD is conducting clinical trials of the stents at two medical centers in Germany. A few months ago, the company announced that it had received initial orders worth $1.5 million from hospitals in Europe and Latin America, even before the product was launched. The company expects to obtain US Food and Drug Administration (FDA) approval for the stents within two years.
In contrast to US Food and Drug Administration (FDA) certification, CE Mark certification only means that the device is safe for use; it does not certify as to the device’s effectiveness.
Published by Globes [online], Israel business news - www.globes.co.il - on October 24, 2007
© Copyright of Globes Publisher Itonut (1983) Ltd. 2007