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Rubicon SVG trial to commence

This article was originally published in The Gray Sheet

Executive Summary

Cardiovascular Research Foundation Chairman Martin Leon, MD, will serve as primary investigator of the RULE-SVG trial of Rubicon Medical's Rubicon Filter saphenous vein graft filter. The study, likely to begin in Q2, will evaluate the filter's ability to capture and remove emboli released into the bloodstream during bypass surgery. The device also is being evaluated in Europe for distal protection during carotid stenting. Boston Scientific recently acquired an 18% share of the Salt Lake City firm for $15 mil. (1"The Gray Sheet" Nov. 10, 2003, p. 21)...

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Rubicon Medical and Boston Scientific expect to launch the RULE-SVG trial of Boston Scientific's Taxus Liberté paclitaxel-eluting stent used in conjunction with Rubicon's Rubicon Filter embolic protection device for the treatment of diseased saphenous vein grafts by year-end, pending IDE approval. The trial will randomize Taxus Liberté patients to treatment with the Rubicon Filter or Boston Scientific's EPI Filterwire, and be used to support regulatory filings for Taxus Liberté and Rubicon Filter in the U.S. (1"The Gray Sheet" March 1, 2004, In Brief)...

Financings In Brief

Rubicon Medical: Boston Scientific buys $15 mil. of Rubicon Medical Series A Preferred Stock convertible into 10.9 mil. shares, bringing the firm's stake up to 18%. Boston Scientific says it will tender an offer for all outstanding shares of Rubicon if it acts on an option to buy the stock of the company's two largest shareholders, CEO Richard Linder and Chairman David Berger, who combined own just under 50%. The option will close 90 days after U.S. regulatory approval of the Rubicon Filter embolic protection system, which has yet to commence U.S. clinicals. European pivotal trials for heart and carotid artery indications are expected to complete in early 2004. Rubicon may wait until after CE mark approval to pursue U.S. indications, which likely will begin with saphenous vein grafts (1"The Gray Sheet" July 28, 2003, p. 6)...

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