Shockwave Medical, part of Johnson & Johnson MedTech, has initiated its pivotal FORWARD CAD investigational device exemption (IDE) study, assessing the safety and effectiveness of the Shockwave Javelin coronary intravascular lithotripsy (IVL) catheter for the treatment of calcified, difficult-to-cross stenotic de novo coronary artery lesions prior to stenting.
The first patient was treated recently by operators Evan Shlofmitz and Ziad Ali at St Francis Hospital & The Heart Center in Roslyn (USA).
“There is an opportunity to improve the treatment of cardiovascular patients with tight, calcific lesions in narrowed coronary vessels that are challenging to cross with balloon-based approaches as currently we have to rely on atherectomy technologies,” said Shlofmitz.
“We are delighted to enrol the first patient in the FORWARD CAD clinical trial to determine whether Shockwave’s novel forward IVL platform can help reduce the recognised risks of atherectomy in this patient population,” adds Ali.
A prospective, multicentre, single-arm study across approximately 35 sites in the USA and UK, FORWARD CAD aims to enrol up to 158 patients with moderate-to-severely calcified, stenotic de novo coronary artery lesions presenting with stable angina or following stabilisation after acute coronary syndrome (ACS) and suitable for non-emergent percutaneous coronary intervention (PCI).
The co-global principal investigators of the study are Robert Yeh (Beth Israel Deaconess Medical Center, Boston, USA) and James Spratt (St George’s University NHS Trust, London, UK) and the US principal investigator is Robert Riley (Overlake Medical Center & Clinics, Seattle, USA).
The forward IVL platform is designed with a single distal emitter that creates ultrasonic shockwaves, with a spherical energy field that extends beyond the tip of the catheter. This novel design delivers lithotripsy closer to highly stenosed calcium lesions than balloon-based platforms.
Nick West, chief medical officer, Shockwave Medical, 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.”
