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Peripheral DES trial

This article was originally published in The Gray Sheet

Executive Summary

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)...

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Rubicon Filter

Embolic protection device indication for use in saphenous vein grafts will be sought using data from a conventional, single-device U.S. study, expected to begin early in 2005, Rubicon Medical says. Initial plans for a joint, randomized RULE-SVG trial with Boston Scientific's Taxus Liberté paclitaxel-eluting stent have been scrapped to ensure "fewer delays and complexities" following FDA feedback, the firm explains (1"The Gray Sheet" Aug. 23, 2004, In Brief). Separately, Rubicon has finalized a license for SurModics' hydrophilic coating to enhance filter deliverability...

Rubicon SVG trial to commence

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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