Pathway Medical Technologies has been granted FDA 510(k) approval to sell its Pathway PV Atherectomy system, which cuts and removes plaque from leg arteries.
The Kirkland, Wash.-based company said its system has expandable, rotating scraping blades with aspiration for preemptive removal of both hard and soft plaque. The device treats peripheral artery disease, which afflicts about 8 million people, according to the American Heart Association (AHA).
Pathway plans to recruit a sales force and build inventory before taking the product to market, said Stephanie Amoss, vice president of marketing.
The company hopes to assemble an initial sales force of 15 to 25 people to begin selling the device in the fourth quarter of this year.