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Bolt Medical developed a next-generation laser-based intravascular lithotripsy system designed to fracture vascular calcium using acoustic pressure waves delivered via a balloon catheter. The technology demonstrated safety and efficacy in pivotal clinical trials such as RESTORE ATK and RESTORE BTK for peripheral artery disease. In December 2024, the company received FDA approval to commence the FRACTURE IDE trial investigating coronary applications. In early April 2025, the FDA cleared the device for above-the-knee use based on RESTORE ATK data. Commercial launch by acquirer Boston Scientific expected in first half of 2026.
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