Boston Scientific: FRACTURE Trial Meets Pre-specified Safety, Effectiveness Endpoints

(RTTNews) - Boston Scientific (BSX) announced positive results from the FRACTURE Investigational Device Exemption trial evaluating the use of the SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter to treat patients with severely calcified coronary artery disease. The company said the study met its primary safety and effectiveness endpoints, demonstrating high rates of freedom from major adverse cardiac events at 30 days as well as procedural success.

The company noted that the investigational SEISMIQ 4CE Coronary IVL Catheter is compatible with the same console used in the SEISMIQ IVL System with the SEISMIQ IVL Peripheral Catheter, which received FDA clearance in 2025 for the treatment of patients with severely calcified peripheral artery disease.

In pre-market trading on NYSE, Boston Scientific shares are up 0.21 percent to $56.06.

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