Boston Scientific has received FDA 510(k) clearance for its Bolt intravascular lithotripsy (IVL) system, marking a significant milestone in its vascular treatment portfolio. The system, designed to enhance percutaneous transluminal angioplasty, disrupts calcium in stenotic lesions before full balloon dilation at low pressures.
Key features of Bolt IVL:
- Advanced Laser-Based IVL: Uses acoustic pressure waves to fracture calcium in coronary and peripheral arteries.
- Directional Energy Delivery: Visible, directional emitters ensure consistent treatment of calcified lesions.
- RESTORE ATK Trial: Evaluated Bolt IVL in 97 patients with above-the-knee stenotic lesions.
Analysts at BTIG expressed optimism over the rapid clearance and noted that Bolt IVL is also under FDA review for below-the-knee applications and is being evaluated in the FRACTURE IDE study for coronary artery disease.
Boston Scientific’s acquisition of Bolt Medical earlier this year strengthens its position in the IVL space, where Johnson & Johnson, Abbott, and emerging players like FastWave and Vantis Vascular are also vying for market share.
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