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News

Avinger receives CE Mark approval for lumectomy catheter for image-guided atherectomy

Avinger : 30 August, 2013  (New Product)
Avinger receives CE Mark approval for Pantheris - a system that combines directional atherectomy capabilities with real-time intravascular visualization to remove plaque from blocked arteries.


Pantheris is designed to remove the blockage while avoiding the disruption of normal arterial wall structures. This new type of image-guided atherectomy is referred to as lumectomy. Currently, approximately 200 million patients worldwide suffer from PAD.



"And now with Pantheris, I won't have to play the guessing game to decide what part of the artery needs to be treated. I'll be able to see what I need to cut, and what should be left alone. The benefits of this advantage for my patients could be dramatic."



"This is a major milestone for Avinger, and I couldn't be more pleased with the progress we've made by getting Pantheris to market in Europe," said founder and Chief Executive Officer John Simpson PhD, MD. "Providing physicians with a tool to see the difference between the healthy artery wall and the disease itself while treating the vessel in real time - this is what I've been working towards for my entire career."



The first commercial Pantheris cases in Europe are to be performed by Arne Schwindt, MD of St Franziskus Hospital in Muenster, Germany. Dr Schwindt is also a Co-principal Investigator of Avinger's US IDE trial, VISION. VISION is a multi-centre, non-randomized global clinical study designed to evaluate the safety and efficacy of Pantheris. "I've always been an advocate of using atherectomy as a minimally invasive way to treat patients with PAD," said Dr Schwindt. "And now with Pantheris, I won't have to play the guessing game to decide what part of the artery needs to be treated. I'll be able to see what I need to cut, and what should be left alone. The benefits of this advantage for my patients could be dramatic."


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