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Medinol: Can Technology Still Win In Stents?

Executive Summary

Medinol, a small Israeli stent company, used innovative stent design and manufacturing processes to develop products that propelled its marketing partner, Boston Scientific, to early leadership in what became the biggest cardiovascular device market of the past decade. Problems resulting in litigation led Medinol to recently terminate the collaboration after six years, leaving the small firm with the choice of going it alone and having to build a worldwide sales and marketing network, or seeking another partner. The break-up occurs at a pivotal point in the development of coronary stent technology; bare metal stents are apparently about to give way to the next-generation drug-eluting stents (DES), which present perhaps an even larger opportunity than that enjoyed bvy their predecessors. Medinol is skipping over DES and is already working on the next-generation stent/drug therapy. Because of consolidation, the stent market is now dominated by four major playuers. Yet, Medinol chose to end its alliance with one of the Big Four to join forces with a much smaller player in this space, WL Gore & Associates Inc. Both Medinol and Gore are R&D-driven, and are betting that the rules of the stent game haven't changed: that ultimately in interventional cardiology, the best technology still wins.

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World Congress of Cardiology: DES Safety Dominates Discussions

While the greater efficacy of drug-eluting stents (DES) compared to bare-metal stents is widely accepted, over the past year, data has continued to build showing that first-generation DES also have a higher late-stage in-stent thrombosis risk, a complication that can cause death 30% of the time, according to some estimates. The findings of these studies had some physicians at this year's World Congress of Cardiology calling for "an immediate halt to DES overuse." However, most conceded that additional randomized trials will be needed to fully understand the potential risks associated with these devices.

Stents Branch Out and Return to Their Start-Up Roots

While innovation in interventional cardiology has historically come from small companies, industry consolidation and a flattening of technology has, in recent years, given the edge to large suppliers, which now all but dominate the field. Drug-eluting stents, which require huge resource expenditures, seem to epitomize this shift of interventional cardiology to a big-company game. But in at least one highly promising area--bifurcated lesions--small companies continue to have the edge in developing a device to effectively treat this significant unmet clinical need. Encouraging for these smaller companies is the fact that the critical technology hurdle in treating bifurcations is primarily mechanical, not biological, enabling new approaches that can potentially complement, not compete against, drug-coated stents.

Gore Partners with Medinol on the Rebound in Global Stent Deal

WL Gore & Associates and Tel Aviv, Israel-based Medinol, both privately-held companies, enetered into a worldwide partnership agreement covering stents and stent systems, the exact terms of which have not been disclosed. What's clear, however, is that the deal enables each company to fill a significant hole in their interventional cardiology product lines, while also restoring worldwide distribution channels for Medinol. The Israeli company, which focuses exclusively on developing and manufacturing innovative stent technology, lost its sales and marketing channel this year after dissolving a longstanding agreement with Boston Scientific. Now, it will be able to utilize the balloon and stent delivery system that Gore plans on unveiling later this year, along with Gore's distribution network, while Gore will have access to Medinol's ionnovative stent line, including the new NIRflex stent.

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