FDA approves Medinol's PioNIR Plus stent

Johnson & Johnson markets the stent elsewhere in the world, but it is not clear who the US distributor will be.

Medinol has received approval from the US Food and Drug Administration (FDA) to sell its PioNIR Plus stent. This is on the basis of the results of a comprehensive trial of the product that was completed a year ago.

The PioNIR Plus stent, also sold under the name Presillion Plus, is a stent developed by Medinol for coronary arteries. It is of the 'bare metal' type, that is, stents that are not coated with medication.

The trial found that the stent was competitive in its performance with both coated and bare stents, particularly in terms of renewed stenosis after surgery, cardiac events after surgery, and formation of blood clots.

The stent is currently sold in Europe and around the world by Johnson & Johnson, but that company does not have a franchise for the product in the US. Johnson & Johnson has a coated stent called Cypher, but last year it announced that it would considerably reduce its cardiology activity, including stents, which is not favorable for sales of Medinol's products.

Because of the state of Johnson & Johnson's cardiology activity, it is also not clear at present who will market the new stent for Medinol in the US. It might be Johnson & Johnson, or another company, or Medinol itself.

Medinol expands

The US is the largest cardiology market in the world, representing 50% of the global market, and so although bare stents only account for 25-30% of it, this is still very attractive for Medinol and any potential partner. Moreover, because of the strict regulatory requirements, the number of competitors in bare stents in the US is low, another reason that this market is attractive. It is mainly the very large companies that are active in this area in the US: Medtronic, Abbott Laboratories, and Boston Scientific.

Medinol, owned by Judith and Kobi Richter, is one of Israel's largest medical device companies, and also one of the most secretive. It has annual sales in the tens, and possibly hundreds, of millions of dollars. It recently enlarged its offices and production plant, so it seems that it is growing. The PioNIR stent (named after Nir Poraz, who was killed in the attempt to rescue abducted soldier Nachshon Wachsman in 1994) is the company's leading product. Medinol has stents and stent supports in various stages of development, but as far as is known it is not active in coated stents.

Medinol made newspaper headlines in the mid-2000s because of a highly publicized court case against Boston Scientific, which was its partner for selling a previous stent, but decided to produce and sell its own stents, in violation of the agreement with Medinol, according to the Israeli company. After five years of legal wrangling, the two companies reached a settlement under which Medinol received $750 million from Boston Scientific, a sum that is twice the largest exit by any Israeli medical device company in the past decade.

Published by Globes [online], Israel business news - www.globes-online.com - on May 10, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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