FDA Clears Angiography Contrast Management System

The FDA has approved a contrast-management system for use in angiography procedures. The CMS-2000 Contrast Management System from Acist Medical Systems (Eden Prairie, MN) allows the physician instantaneous and variable control over the amount and flow of contrast used in diagnostic and interventional procedures.

In the typical angiography procedure, a combination of syringes and large motorized injectors are connected to a catheter via an array of tubing and manifolds to inject x-ray contrast. This requires the physician to use either physical hand pressure to administer the contrast, or to utilize a mechanical power injector, which only delivers a fixed dose. The CMS-2000 allows the physician to deliver a variable amount of contrast or saline via a push-button hand control device.

This new system is designed to save hospitals the additional cost of wasted contrast media at the end of the procedure by allowing for the re-use of the syringe for up to five cases, while still maintaining sterility. Only the part of the disposable kit that comes into contact with patient fluid must be changed out before the next procedure.

The CMS-2000, which currently carries the CE Mark, will be launched in the U.S. cardiology market in the coming weeks by the company's corporate partner, Bracco Device Division (BDD). BDD retains exclusive marketing and distribution rights for the CMS-2000 product line in the U.S. and Canada.

Edited by Ursula Jones