Avinger (NSDQ:AVGR) said today it launched its Pantheris lumivascular atherectomy system with extended nosecone in the European Union, touting that the device has been used in its first human patients.
The device was used by Dr. Arne Schwindt in treating peripheral artery disease in three patients at Münster, Germany’s St. Franziskus Hospital, the Redwood City, Calif.-based company said.
“Despite the difficult nature of these particular interventions, I was able to safely and effectively achieve positive outcomes for these patients using the new version of Pantheris with the extended nosecone. I am excited to continue to use this technology in lesions with higher plaque burden, and continue to see the added benefit of the design improvements incorporated into the next generation Pantheris platform,” Dr. Schwindt said in a prepared statement.
The new version of the device features a longer nosecone for improved plaque removal, Avinger said, and is qualified for sale in European Union under its existing CE Mark. The company said the extended nosecone increases storage capacity of the Pantheris system by 75%, which it says will result in improved procedural efficiency.
“We appreciate Dr. Schwindt’s continued partnership with us in our objective to improve physician user experience with our technology while continuing to generate positive patient outcomes. Dr. Schwindt’s feedback will continue to be invaluable as we launch our Pantheris next generation platform in additional sites both in the EU and in the US, once we receive FDA 510(k) clearance,” prez & CEO Jeff Soinski said in a press release.
Earlier this month, Avinger said it inked a $5 million deal to settle a class-action investors suit against the company and several of its officers and directors.