The FDA approved the Freezor Xtra cryoablation catheter to treat patients with an abnormal heart rhythm known as atrioventricular nodal re-entrant tachycardia (AVRT).
Medtronic, which manufactures the catheter, announced the approval on Feb. 16. The company said the catheter is used to freeze cardiac tissue and block unnecessary signals in the heart. The FDA had previously approved the catheter for use during minimally invasive cardiac surgeries.
The expanded approval was based on the ICY-AVNRT trial, which enrolled 397 patients at 34 sites in the U.S. and Canada. Six months after the procedure, 92.6 percent of patients were free from AVRNT. The trial also met its safety endpoints. Medtronic said there were no primary safety events related to the catheter.
Approximately 319,000 people live with AVNRT and more than 49,000 people are diagnosed with the condition each year, according to Medtronic.
“The expanded indication for this catheter will allow more patients to benefit from a safe and effective therapy that can prevent heart racing, and allow them to get back to their normal activities," Peter Wells, MD, heart rhythm doctor at Baylor Heart and Vascular Hospital in Dallas and principal investigator of the ICY-AVNRT trial, said in a news release.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.