FORWARD CAD Data Presented for Johnson & Johnson’s Shockwave Javelin Coronary IVL Catheter

November 2, 2026—Johnson & Johnson announced that 30-day results from the pivotal FORWARD CAD investigational device exemption study evaluating the Shockwave Javelin coronary intravascular lithotripsy (IVL) catheter were presented at TCT 2026 in San Diego, California.

The company noted that the catheter remains investigational in the United States and is designed to modify calcified, difficult-to-cross de novo coronary lesions before stent placement.

FORWARD CAD is a prospective, multicenter, single-arm study conducted at 28 sites in the United States and United Kingdom. The cohort included 158 patients with de novo coronary lesions showing moderate to severe calcification on angiography and either > 90% stenosis with a lesion length < 40 mm or a chronic total occlusion (CTO) with a J-CTO score of 1.

Johnson & Johnson reported that the study exceeded prespecified performance goals for both its primary effectiveness endpoint (technical success) and primary safety endpoint (freedom from major adverse cardiovascular events [MACE]) through 30 days:

• Technical success was achieved in 93.6% of patients, defined as successful Shockwave Javelin coronary IVL–enabled lesion crossing without serious angiographic complications at final imaging.
• At 30 days, 93.4% of patients were free from MACE, a composite of cardiac death, myocardial infarction, or target vessel revascularization.

Among treated lesions, 96% were moderately or severely calcified, mean diameter stenosis was 81%, and 20% were CTOs. Low complication rates were reported, with serious angiographic complications at final imaging occurring in 1.3% of patients, noted the company.

“Successfully treating heavily calcified lesions begins with being able to facilitate lesion crossing, an enduring challenge that can limit what physicians can achieve for patients,” commented Robert Yeh, MD, MBA, Global Coprincipal Investigator and Section Chief of Interventional Cardiology at Beth Israel Deaconess Medical Center, in the company’s press release. “These findings represent an important step toward overcoming that barrier and creating a viable treatment path for patients whose disease may be beyond the reach of conventional balloon-based calcium modification approaches.”

The Shockwave Javelin coronary IVL catheter uses a single emitter at its distal end to generate acoustic pressure waves in a spherical field extending beyond the catheter tip. According to Johnson & Johnson, this configuration allows IVL energy to be delivered closer to tightly narrowed, calcified lesions than balloon-based IVL systems.

“The FORWARD CAD IDE study shows that difficult-to-cross lesions may be treated successfully without compromising safety,” added James Spratt, MD, Global Coprincipal Investigator at St. George’s University NHS Trust. “This study suggests that Shockwave Javelin could help physicians manage patients with limited treatment options.”