This article is more than 5 years old. Information may no longer be current.
Other Key Recent FDA Developments
Click Here to Manage Email Alerts
Below are other recent FDA News headlines. To read more, search the titles online at Healio.com/Intervention.
DES System Designed for Patients with Large Vessels Approved by FDA
Medtronic announced the FDA approval of a new drug-eluting stent designed for patients with larger vessels and for transradial access.
FDA Designates Recall of Catheters as Class I
The FDA has designated Vascular Solutions’ product recall of a line of catheters as a class I recall, the most serious kind. The recall affects 7,054 devices manufactured and distributed in the United States from May 2015 to April 2017.
Balloon-expandable Covered Stent Launched in US
A balloon-expandable covered stent for treatment of iliac artery occlusive disease recently received FDA approval and is now commercially available in the United States, C.R. Bard announced.
Coronary Dilatation Catheters Receive FDA Clearance
OrbusNeich announced that a line of coronary dilatation catheters for the treatment of patients with acute MI and coronary ischemia has received 510(k) clearance from the FDA and has launched in the United States.