CVD catheter cleared for new uses
The Food and Drug Administration has given Endosonics subsidiaryCardiovascular Dynamics (CVD) clearance to market expanded applicationsfor its Periflow line of peripheral balloon angioplasty-infusioncatheters. Earlier this year, the FDA cleared Periflow
The Food and Drug Administration has given Endosonics subsidiaryCardiovascular Dynamics (CVD) clearance to market expanded applicationsfor its Periflow line of peripheral balloon angioplasty-infusioncatheters. Earlier this year, the FDA cleared Periflow for percutaneoustransluminal angioplasty (PTA) as well as the infusion of site-specificcontrast media for peripheral vascular anatomy (SCAN 2/15/95).The agency's most recent action allows Periflow to be marketedfor both PTA and the site-specific delivery of therapeutic pharmaceuticalsinto the peripheral vasculature. CVD, of Irvine, CA, plans tobegin U.S. shipments of Periflow by the end of this year.
In other news, Endosonics said CVD has received approval fromthe Japanese Ministry of Health to market its Controlled AngioplastyTechnology catheters in Japan.