UPDATED with comment from Zoll, trial investigator; trial details.
Advanced Circulatory Systems Inc.
December 23, 2014 by Brad Perriello
Zoll Medical is averaging an acquisition per month over the fall, announcing its 3rd deal in as many months, this time for Advanced Circulatory Systems and its non-invasive circulation assist devices.
The FDA’s Circulatory System Devices Advisory Panel voted this month to recommend approval for Advanced Circulatory’s ResQCPR system for use during emergency CPR to help increase survival and minimize brain damage.
Minnesota medical device maker Advanced Circulatory Systems won a panel date with the FDA to review a PMA bid for its ResQCPR resuscitation systems.
MASSDEVICE ON CALL — An FDA advisory panel will meet today to discuss the possibility of putting transvaginal mesh products into a higher risk category, effectively pulling existing devices off the market until further testing can prove safety and efficacy.
The latest report from the watchdog agency’s Obstetrics & Gynecology Devices Panel recommended revoking 510(k) clearance for the devices, which are used to treat pelvic organ prolapse, over rising concerns that they may expose patients to unnecessary risk without offering clinical benefit above safer options.
Advanced Circulatory Systems Inc. released positive results for a clinical trial for its ResQPump and ResQPOD cardiopulmonary resuscitation assistance devices.
The Roseville, Minn.-based CPR device developer and manufacturer said results from the study showed that the devices, when used in tandem, gave cardiac arrest victims a 53 percent better chance of survival than if they received standard CPR.