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First Drug-Coated Balloon IDE: A Conversation With Lutonix CEO Dennis Wahr

This article was originally published in The Pink Sheet Daily

Executive Summary

Following a four-year effort with FDA, Minneapolis start-up Lutonix recently met its goal to become the first company to gain an investigational device exemption for a drug-coated balloon.

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Cook Medical Makes Progress In Peripheral Stent Space

Cook Medical is making advances in the peripheral stent market with the imminent launch of its Formula balloon-expandable renal stent system, and a recent report of two-year data for its PMA-pending Zilver PTX paclitaxel-eluting stent.

TCT In Brief

DES in the leg: Cook Medical's Zilver PTX is the first drug-eluting stent to show clear improvements in treating peripheral artery disease over standard angioplasty and provisional bare-metal stenting in a randomized trial. The paclitaxel-eluting, polymer-free stent met its safety and effectiveness endpoints in Cook's 479-patient pivotal study presented Sept. 24 at the Transcatheter Cardiovascular Therapeutics meeting in Washington, D.C. Patients with femoropopliteal artery disease randomized to Zilver PTX had an event-free-survival rate (safety) of 90.4% compared to 82.6% in patients randomized to standard angioplasty. On effectiveness, Zilver achieved an 83.1% patency rate. About half of the angioplasties in the control group were judged to be "suboptimal," requiring either a bare-metal stent or Zilver to be placed. Lesions that received "standard care," i.e. either had an "optimal" angioplasty or received a subsequent bare-metal stent, achieved a 67% patency rate. Lesions in the suboptimal group that ultimately received Zilver achieved an 89.9% patency rate compared to 73% in the suboptimal bare metal stent patients. Cook sent the results to FDA this past summer as part of Zilver PTX's pending PMA submission

Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind

Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.





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