FDA approves Medinol's medicated stent

Judith and Kobi Richter  photo: Yossi Zeliger
Judith and Kobi Richter photo: Yossi Zeliger

The $750 million compensation Medinol won from Boston Scientific enabled it to develop the new stent, which will make it more competitive. 

Medinol, owned by Kobi and Judith Richter, announced at the end of last week that the US Food and Drug Administration (FDA) had approved its EluNIR drug-eluting (medicated) stent for the treatment of patients with narrowing or blockages to their coronary arteries. Medinol says that the EluNIR stent system is designed with a novel metallic spring tip and the narrowest strut width of any stent on the US market to help clinicians easily deliver this new DES in highly complex anatomy and disease.

After several years of close competition, medicated stents are now considered preferable to bare metal stents. The medicate stent market is worth billions of dollars annually and is growing, and so the new stent, which is the first that Medinol has launched for a long time, should improve the company's competitiveness. Medinol employs about 300 people, most of them in Jerusalem. It is a somewhat secretive company, but its annual revenue is believed to be in the hundreds of millions of dollars.

Medinol was a pioneer of stents, and developed a bare metal stent that was marketed in the 1990s by Boston Scientific. Boston Scientific, however, started to produce its own stents, and Medinol sued it, winning $750 million damages. This enabled Medinol to invest in the long and expensive process of developing the new stent. Medinol's bare metal stent is now marketed by Cordis, part of Cardinal Health, which will also market the new product.

FDA approval for the EluNIR product was obtained after it demonstrated a 5.4% Target Lesion Failure rate among 1,919 patients from 76 sites in eight countries, the lowest reported Target Lesion Failure rate in a contemporary US pivotal study, and a zero percent rate of late stent thrombosis at 12 months. Medinol recently obtained CE-mark for the EluNIR stent, and it is currently being used by physicians in Europe.

"Medinol has a legacy of developing innovative interventional cardiovascular technologies, which has culminated today with the FDA approval of the EluNIR DES," said Dr. Yoram Richter, chief scientific officer at Medinol (and the son of Kobi and Judith Richter). "For more than 20 years, Medinol has continuously raised the bar for the quality and performance of stenting systems. With our innovative manufacturing process, the EluNIRDES offers clinicians the latest generation DES. Notably, the FDA approval of the EluNIR DES marks the first such approval for a privately held company based outside of the US."

Published by Globes [online], Israel business news - www.globes-online.com - on December 4, 2017

© Copyright of Globes Publisher Itonut (1983) Ltd. 2017

Judith and Kobi Richter  photo: Yossi Zeliger
Judith and Kobi Richter photo: Yossi Zeliger
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