Pathway Medical Technologies’ Jetstream G2
This article was originally published in The Gray Sheet
Executive Summary
Endovascular device maker launches second-generation Jetstream G2 peripheral atherectomy catheter for removing plaque, calcium buildup, thrombus and fibrotic lesions in lower limb arteries after receiving 510(k) clearance Feb. 2. Peripheral artery disease affects around 12 million Americans and is associated with high blood pressure, diabetes, heart disease, stroke and aging, the firm says. Jetstream G2's design enhancements over the first-generation Jetstream, which received FDA clearance in September 2008, include an aspiration port that is separate from the cutting mechanism to provide greater aspiration efficiency and a masticating system located within the port to help break aspirated material into smaller pieces before removal, the firm explains