Boston Scientific receives FDA approval on breakthrough heartbeat treatment
New England Council member, Boston Scientific, has received approval from the United States Food and Drug Administration for a new catheter system to treat patients with atrial fibrillation, a condition that causes an irregular heartbeat.
The POLARx Cryoablation Balloon Catheter delivers targeted cryotherapy to the pulmonary vein by freezing tissue to block irregular electrical signals from the brain. The device utilizes two catheter balloon sizes, which allows physicians to provide minimally invasive and highly personalized treatment tailored to match their patients’ individual anatomy. Boston Scientific demonstrated the safety and efficiency of this exciting new technology in a global clinical trial that passed with no reports of moderate or severe adverse reactions.
“The U.S. approval of the POLARx Cryoablation System, which has been used in more than 25,000 patients worldwide to date, marks an exciting advancement for the treatment of AF and a new era of cryoablation capabilities,” said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. “By prioritizing procedural flexibility and individualized care, this offering transforms a key therapy in the electrophysiology space, addresses the unmet needs of physicians and affirms our commitment to making meaningful innovations to established technologies.”
The New England Council would like to congratulate Boston Scientific for the success of this innovative technology.
Read more in the Worcester Business Journal.