The breakthrough device, Shockwave C2 IVL catheter, designed to fracture calcium in coronary arteries using pulsating sonic pressure waves, which facilitates the delivery of stents and expansion to improve blood flow to the heart.
This latest technology is an adaptation of urologic lithotripsy, a technique used in treating kidney stones into small pieces that can then pass from the body naturally.
The calcium accumulated in coronary artery restricts artery dilation and physically impairs blood flow, and results in inhibition of stent expansion.
The condition is said to be the most important predictor of restenosis and early stent thrombosis, or coronary artery re-narrowing and blood clots, within the stent after-stent procedures.
The device is designed to deliver short bursts of sonic pressure waves through the artery wall to break up hardened plaques without harming the soft tissue.
A catheter balloon is advanced to the calcified lesion and then inflated with fluid. The device creates a small bubble within the balloon that expands and collapses to generate the sonic waves that travel through the vessel and crack the calcium. After the calcium has been fractured, the balloon can be expanded and angioplasty is performed.
Currently, the device is being tested in DISRUPT CAD III, an Investigational Device Exemption (IDE) study, in which 442 patients are expected to be enrolled.
DISRUPT CAD III is a prospective, non-randomized, multicenter global IDE study to demonstrate the safety and effectiveness of the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter in de novo, calcified, stenotic, coronary arteries before stenting.
The US FDA has granted a breakthrough device designation to Shockwave Medical's intravascular lithotripsy (IVL) device.
