FDA Approves Cordis' Selution Device for Narrowed Vessel Treatment
What happened
Cordis received FDA approval for a new device, the Selution drug-coated balloon catheter, designed to treat narrowed vessels. This device delivers medication to the artery without requiring a permanent metal implant. Cordis is scaling up production and hiring 50 new employees in Irvine to meet expected demand following the approval.
From ocbj.com
Why it matters
The approval adds a new product to Cordis' extensive heart care portfolio. The Selution balloon is noted as the first and only of its kind approved in the U.S. to use sirolimus. Cordis plans to use its four Irvine facilities as exclusive manufacturing sites for Selution.
Cordis is a subsidiary of Cardinal Health, following an acquisition completed in 2015.
From ocbj.com
Who's involved
- FDARegulatory agency that granted approval for the new device.
- Cardinal HealthParent company of Cordis.
- IrvineLocation designated for exclusive Selution manufacturing sites.
Keep exploring
The entities involved
- FDA
-
Johnson & Johnson
U.S multinational medical devices, pharmaceutical and consumer packaged goods manufacturer
-
Cardinal Health
Healthcare company