Boston Scientific touted a pair of FDA wins for cardiac ablation devices today, announcing pre-market approval for its IntellaTip MiFi XP high-resolution catheter and 510(k) clearance for the Zurpaz steerable sheath.
The IntellaTip is designed to help pinpoint cardiac ablation sites for surgeons, using high-resolution data to more accurately locate ablation points.
The PMA indication is for atrial flutter, a heart abnormality that affects more than 1 million Americans, according to the Natick, Mass.-based medical device company.
Boston Scientific said the FDA also granted a green light for the Zurpaz 8.5F steerable sheath, used to access the heart during catheter placement.
"We believe that the IntellaTip MiFi XP approval, combined with the introduction of our Zurpaz steerable sheath, demonstrates how we are delivering on our promise to provide electrophysiologists with meaningful innovation and complete solutions," Pete Sommerness, general manager for Boston’s electrophysiology business, said in prepared remarks.
Boston Scientific closed a 10-patient feasibility trial for the IntellaTip MiFi XP ablation catheter in May. At the time, the company said it’s planning to release a line of ablation catheters in coming years to tap the growing, $2.5 billion electrophysiology market.