ACS
This article was originally published in The Gray Sheet
Executive Summary
Lilly subsidiary Advanced Cardiovascular Systems begins marketing its ACS Edge coronary dilatation catheter, the company announced Oct. 7. The over-the-wire catheter, which was approved via a PMA supplement on July 29, was launched in Japan in June and in the U.S. and Europe in September. The ACS Edge has a smooth inner lumen and small crossing profile that is "achieved through a new, proprietary balloon-tip forming process," the firm says. The catheter, which is priced at $695, is 20 mm long and is available in widths from 1.5-4.0 mm. The company says that it is awaiting approval of PMA supplements, submitted in August, for ACS Edge catheters in lengths of 30 and 40 mm.
You may also be interested in...
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.
Medicare Reimbursement For Part B Drugs Is 48% Above 340B Prices To Hospitals, MedPAC Finds
New study updates past commission analyses and highlights the significant margin between Medicare payments for drugs and the prices paid by 340B-eligible providers.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.