FRACTURE IDE Trial Results for Boston Scientific SEISMIQ™ 4CE Catheter

Boston Scientific has announced positive results from the FRACTURE IDE trial evaluating the SEISMIQ™ 4CE Coronary Intravascular Lithotripsy Catheter for patients with severely calcified coronary artery disease. The trial met its primary safety and effectiveness endpoints, showing high rates of freedom from major adverse cardiac events at 30 days and procedural success. The trial, involving 420 patients, demonstrated that stents were successfully delivered in all treated patients, with no deaths reported. These findings may support regulatory submissions for the catheter and potentially enhance treatment options for severe coronary artery disease.