logo
  

BD Says Rotarex Atherectomy System Receives Expanded 510(k) Clearance From FDA - Quick Facts

Medical technology company Becton, Dickinson and Co. or BD (BDX) announced Wednesday that it has received 510(k) clearance for expanded indications from the U.S. Food and Drug Administration (FDA) for the Rotarex Atherectomy System.

The Rotarex Atherectomy System is a rotational excisional device that is built to remove and aspirate varying lesion morphologies including plaque and thrombus in the peripheral arteries.

The Rotarex System, already cleared for use in native arterial vessels, now has the expanded indications to treat within peripheral arteries fitted with stents, stent grafts, and native or artificial bypasses.

The FDA clearance of the Rotarex Atherectomy System's new expanded indications follows more than 10 years of real-world clinical experience involving the treatment of thousands of patients globally.

Now, physicians can use a proven tool to address some of their most challenging peripheral arterial disease (PAD) lesions, including the treatment of in-stent restenosis.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Home improvement company Lowe's and pet retailer Petco Health and Wellness Co. are set to launch a pilot store-in-store program whereby a total home solution will be offered to customers by bringing home improvement as well as pet care products, services and expertise together under the same roof. Chevron Corporation (CVX) reported fourth quarter profit of $5.1 billion or $2.63 per share, compared to a loss of $665 million or $0.33 per share, previous year. The company's U.S. upstream operations earned $2.97 billion, compared to $101 million, a year ago. The company said the improvement was primarily... While reporting financial results for the fourth quarter on Friday, Colgate-Palmolive Co. (CL) initiated its earnings and sales growth guidance for the full-year 2022. For fiscal 2022, the company now expects earnings per share to grow in double-digit percentage and adjusted earnings per share growth...
Follow RTT