Shockwave Medical announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter.
Shockwave said that it is engaged in development and commercialisation of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, and its platform is currently in an Investigational Device Exemption (IDE) study called DISRUPT CAD III.
Shockwave Medical president and chief executive officer Doug Godshall said: “Receiving Breakthrough Device Designation is an important milestone, validating IVL as a unique solution for complex calcified coronary disease.
“Our international customers have responded very positively to Shockwave’s C2 since its commercial launch last year, and our team has been working hard to bring this transformational technology to patients with coronary disease in the United States.”
Shockwave C2 IVL Catheter breaks calcium in coronary arteries
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.
Shockwave has designed the C2 IVL Catheter to break problematic calcium to improve blood flow to the heart muscle, using sonic pressure waves that facilitate stent delivery, deployment and optimal expansion.
Under the Breakthrough Device Program, FDA is expected to provide priority review and interactive communication for Shockwave during C2 IVL Catheter premarket review phase.
Godshall added: “We are encouraged that the FDA has determined that Shockwave C2 qualifies as a Breakthrough Device and we look forward to working collaboratively with the agency so we can make Shockwave C2 available as expeditiously as possible.”
The DISRUPT CAD III is a prospective, non-randomised, multicentre IDE study designed to evaluate the safety and effectiveness of the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter in de novo, calcified, stenotic, coronary arteries prior to stenting.
Shockwave said that its C2 Coronary IVL catheters are available for the treatment of de novo coronary artery disease in Europe and select other geographies, and are available only for investigational use in the US.
