Johnson & Johnson (J&J) MedTech’s Shockwave Medical has commenced the multicentre, prospective FORWARD CAD investigational device exemption (IDE) study of the Javelin coronary intravascular lithotripsy (IVL) catheter for treating “difficult-to-cross”, calcified coronary lesions.
This study aims to assess the safety and effectiveness of the device in treating these de novo coronary artery lesions before stenting.
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The first subject in the study recently received the treatment from St Francis Hospital & The Heart Center’s intravascular imaging director Evan Shlofmitz and DeMatteis Cardiovascular Institute director Ziad Al.
The single-arm trial across nearly 35 US and UK sites seeks to enrol up to 158 subjects with moderate-to-severely calcified, stenotic de novo coronary artery lesions.
These patients will present with stable angina or after stabilisation from acute coronary syndrome (ACS) and are suitable for non-emergent percutaneous coronary intervention (PCI).
The trial’s co-global principal investigators are Robert Yeh from Beth Israel Deaconess Medical Center and James Spratt from St George’s University National Health Service (NHS) Trust.
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By GlobalDataOverlake Medical Center & Clinics’s interventional cardiologist Robert Riley is the US principal investigator.
Shockwave Medical chief medical officer Nick West said: “Our commitment to realising the full potential of IVL to optimise cardiovascular care is unwavering, and we believe Javelin has the promise to transform how interventional cardiologists treat patients with tight, challenging-to-cross, calcified coronary lesions.
“We look forward to learning more about how our enhanced IVL capabilities could lay the foundation for a new era of treatment that improves outcomes for these complex patients.”
Shockwave’s IVL technology leverages sonic pressure waves to disrupt calcified plaque, leading to enhanced patient outcomes.
Additionally, the company’s Reducer technology, currently under clinical investigation in the US and CE-marked in the European Union and the UK, aims to alleviate refractory angina by redistribution of blood flow in the heart.
Last month, Shockwave introduced the Javelin Peripheral IVL Catheter in the US market, targeting peripheral artery disease.
