FORWARD CAD, an FDA investigational device exemption (IDE) study, evaluates the safety and efficacy of the company’s latest intravascular lithotripsy (IVL) catheter. It aims to treat calcified, difficult-to-cross stenotic de novo coronary artery lesions prior to stenting. Dr. Evan Shlofmitz and Dr. Ziad Ali, both of St. Francis Hospital & The Heart Center recently treated the first patient.
Javelin, Shockwave’s latest catheter, aims to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD). The novel, non-balloon IVL platform delivers a similar safety and efficacy profile to the company’s legacy catheters.
Shockwave designed Javelin with a single 120-pulse lithotripsy emitter at the distal tip of the catheter. The company developed it for use in sub-total occlusions or extremely narrowed vessels. (Read more about the Javelin IVL catheter at Medical Design & Outsourcing.)
Shockwave’s FORWARD CAD study spans approximately 35 sites in the U.S. and UK. Investigators aim to enroll up to 158 patients with moderate-to-severely calcified, stenotic de novo coronary artery lesions presenting with stable angina or following stabilization after acute coronary syndrome (ACS). These patients are suitable for non-emergent percutaneous coronary intervention (PCI).
“Our commitment to realizing the full potential of IVL to optimize 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,” said Dr. Nick West, chief medical officer, Shockwave Medical. “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.”
