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# Enhanced Coronary Lithotripsy Catheter OK’d
- URL: https://www.fdaweb.com/enhanced-coronary-lithotripsy-catheter-okd/
- Published: 2023-10-20T12:00:00.000Z
- Updated: 2026-09-14T14:13:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155614

FDA has approved a Shockwave Medical PMA for what the company calls an “enhanced” Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) catheter, indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic *de novo* coronary arteries prior to stenting. Shockwave says the device provides 50% more pulses per catheter than the previous model that was approved in 2021\. “The enhancements of Shockwave C2+ will be an added benefit of IVL for optimally treating complex calcium, including more diffuse disease, as well as nodular and thick, eccentric calcium,” it adds.

According to the company, the IVL catheter is delivered across a calcified lesion and the integrated balloon is expanded to facilitate energy transfer. “An electrical discharge from the emitters vaporizes the fluid within the balloon, creating a rapidly expanding and collapsing bubble that generates sonic pressure waves,” it says. “The waves create a localized field effect that travels through soft vascular tissue, selectively cracking intimal and medial calcium within the vessel wall. After calcium modification, the integrated balloon may subsequently be used to dilate the lesion at low pressure in order to maximize luminal gain.”