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February 8, 2016
Stentys's Self-Apposing, Self-Expanding DES for BTK Launched in Europe
February 8, 2016—Stentys announced the initiation of commercialization of the company’s self-apposing, self-expanding paclitaxel-eluting stent for a below-the-knee (BTK) indication. The first distribution agreements for its drug-eluting stent for treating BTK arteries were made in Germany and Belgium. On January 28, the company advised that the first interventions using the device to treat BTK artery disease were successfully conducted in live-case procedures broadcast at LINC 2016, the Leipzig Interventional Course held January 26–29 in Leipzig, Germany.
On September 28, 2015, Stentys announced European CE Mark approval for the BTK indication based on the results achieved by the PES BTK-70 study, where it prevented amputation in 99% of the 70 patients treated for critical limb ischemia.
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