Medtech titan St. Jude Medical (NYSE:STJ) won FDA premarket approval for its Cool Flex cardiac ablation system with indication to treat irregular heart rhythms.
St. Jude accepted the win quietly, with not announcements listed on its site despite approval having been granted nearly a month ago, according to an FDA memo.
St. Jude was not immediately available for comment.
FDA regulators granted labeling for the Cool Flex device in ablating tissue associated with irregular heart rhythms. The catheter uses radiofrequency energy generated by an external source to "destroy the small areas of tissue that block the heart’s internal electrical signals that cause the typical atrial flutter."
In clinical trials the system corrected typical atrial flutter for at least 30 minutes following treatment in 98.8% of the 179 patients evaluated. The treatment was sustained out to 3 months for 150 of those patients, according to the FDA notice..
St. Jude’s approval requires that the company provide annual reports on the "continued reasonable assurance of the safety and effectiveness of the device," including quantities of the device sold and distributed.
"The distribution data will serve as a denominator and provide necessary context for FDA to ascertain the frequency and prevalence of adverse events, as FDA evaluates the continued safety and effectiveness of the device," the federal watchdog agency said in an approval letter dated December 18.
The Cool Flex ablation system won CE Mark approval in the European Union in the summer of 2010.
