Shockwave Initiates FORWARD CAD IDE Study of Javelin Coronary IVL Catheter

April 7, 2025—Shockwave Medical, Inc., part of Johnson & Johnson MedTech, announced it has initiated its pivotal FORWARD CAD investigational device exemption (IDE) study to assess 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 before stenting.

According to the company, the prospective, multicenter, single-arm FORWARD CAD IDE study will be conducted across approximately 35 sites in the United States and the United Kingdom. The company advised that the study aims to enroll up to 158 patients with moderately to severely calcified, stenotic, de novo coronary artery lesions presenting with stable angina or following stabilization after acute coronary syndrome and suitable for nonemergent percutaneous coronary intervention.

Shockwave stated that the first patient in the study was treated by Evan Shlofmitz, DO, and Ziad Ali, MD.

Dr. Shlofmitz is Director of Intravascular Imaging and Dr. Ali is Director of the DeMatteis Cardiovascular Institute and Investigational Interventional Cardiology at St. Francis Hospital & The Heart Center in Roslyn, New York.

“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,” commented Dr. Shlofmitz in the company’s press release.

Dr. Ali added, “We are delighted to enroll the first patient in the FORWARD CAD clinical trial to determine whether Shockwave’s novel forward IVL platform can help reduce the recognized risks of atherectomy in this patient population.”

The Co-Global Principal Investigators of the study are Robert Yeh, MD, with Beth Israel Deaconess Medical Center in Boston, Massachusetts, and James Spratt, MD, with St. George’s University NHS Trust in London, United Kingdom. The United States Principal Investigator is Robert Riley, MD, with Overlake Medical Center & Clinics in Bellevue, Washington.