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In Brief: Cardiovascular Dynamics

This article was originally published in The Gray Sheet

Executive Summary

Cardiovascular Dynamics: FDA approves PMA supplement for its FACT-22 (Focus Angioplasty Catheter Technology) and ARC-22 (Active Response Catheter) coronary balloon angioplasty catheters. The products feature longer balloon inflation lengths (22 mm), "which expand the clinical applications and potential market" for CVD's Focus technology, the company says. CVD gained approval in January for the original version of its FACT catheter; an original version of the ARC was approved in June. CVD's Focus technology provides users "both low and high balloon inflation pressures within a single catheter," the company says. CVD plans to launch the new FACT-22 and ARC-22 versions at the scientific sessions of the American Heart Association in November...

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