First Drug-Coated Balloon IDE: A Conversation With Lutonix CEO Dennis Wahr
This article was originally published in The Pink Sheet Daily
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 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.
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
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.