Spectranetics Corp. Thursday announced the U.S. Food and Drug Administration had cleared two new products for removing infected pacemaker leads that are designed to supplement its medical laser.
The Colorado Springs-based company said the new products represent its “entry into the mechanical extraction device market and complement” its lasers. Spectranetics CEO Scott Drake said in the release that “physicians consistently emphasize the need for the right tool at the right time for lead management. By providing a broader range of clinical solutions, our goal is continue to enable safe, predictable outcomes” in removing infected leads, a market the company estimates at 400,000 patients annually.
The approval comes just three days after Spectranetics told stockholders to expect lower revenue and higher losses as a results of in the first quarter when its financial results are released April 23 as a result of a “temporary disruption” tied to a sales force expansion.