J&J’s Shockwave Medical Begins Forward IVL Study

Shockwave Medical, part of Johnson & Johnson MedTech, has initiated its pivotal FORWARD CAD investigational device exemption (IDE) study.

The study will evaluate the Shockwave Javelin coronary IVL catheter to treat calcified, difficult-to-cross stenotic de novo coronary artery lesions prior to stenting. The first patient was treated recently by operators Evan Shlofmitz, DO, FACC, Director of Intravascular Imaging and Ziad Ali, MD, D.Phil., Director of the DeMatteis Cardiovascular Institute and Investigational Interventional Cardiology at St. Francis Hospital & The Heart Center in Roslyn, N.Y.

The prospective, multicenter, single-arm study hopes to enroll up to 158 patients at 35 U.S. and UK sites with moderate-to-severely calcified, stenotic de novo coronary artery lesions presenting with stable angina or following stabilization after acute coronary syndrome (ACS) and suitable for non-emergent percutaneous coronary intervention (PCI).

The IVL (intravascular lithotripsy) platform has a single distal emitter that creates ultrasonic shock waves with a spherical energy field that extends beyond catheter’s tip. It delivers lithotripsy closer to highly stenosed calcium lesions than balloon-based platforms, the company said.

“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 Nick West, MD, chief medical officer at 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.”