Brind.
  1. Corporate restructuring news includes the transformation of CORDIS from a division of Cardinal Health, the acquisitions of Guidant by Boston Scientific and Abbott Laboratories, and appointments involving Cirtec Medical.

FDA Approves Cordis' Selution Device for Narrowed Vessel Treatment

1 report, 1 independent Updated Mon 00:00
AI-generated briefing. Brind wrote this from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.

What happened

Some supportReported by 1 outlet

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

Some supportBrind's analysis of the reports

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.

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The entities involved

Coverage

Newest first; wire copies grouped