FORWARD CAD IDE: Shockwave Javelin Coronary IVL Catheter Delivers Positive Results in Pivotal Study
30-day data demonstrate favorable safety and efficacy outcomes for the Shockwave Javelin Coronary Intravascular Lithotripsy (IVL) catheter when used to modify highly stenosed, challenging calcific coronary lesions
30-day data demonstrate favorable safety and efficacy outcomes for the Shockwave Javelin Coronary Intravascular Lithotripsy (IVL) catheter when used to modify highly stenosed, challenging calcific coronary lesions
SAN DIEGO – Johnson & Johnson announced 30-day results from the FORWARD coronary artery disease (CAD) investigational device exemption (IDE) study evaluating the safety and effectiveness of the Shockwave Javelin Coronary Intravascular Lithotripsy (IVL) Catheter. The catheter, an investigational device in the U.S., is designed for the treatment of calcified, difficult-to-cross stenotic de novo coronary artery lesions prior to stenting. The results were presented as featured clinical research at the 2026 Transcatheter Cardiovascular Therapeutics (TCT) congress in San Diego, California.
In the 158-patient pivotal cohort, event rates for the primary safety and effectiveness endpoints exceeded pre-specified performance goals. Key findings from the study include:
- 93.6% technical success rate (primary effectiveness endpoint, defined as successful Shockwave Javelin Coronary IVL-enabled lesion crossing without serious angiographic complications at final imaging).
- 93.4% freedom from major adverse cardiovascular events (primary safety endpoint, defined as a composite of cardiac death, myocardial infarction or target vessel revascularization) through 30 days.
Additionally, the study demonstrated low complication rates in a highly complex lesion population. Among treated lesions, 96% were moderately or severely calcified, with a mean diameter stenosis of 81% and chronic total occlusions present in 20% of lesions. Despite this, serious angiographic complications at final imaging were observed in only 1.3% of patients.
“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,” said Robert Yeh, M.D., MBA, global co-principal investigator of the study and Section Chief, Interventional Cardiology, Beth Israel Deaconess Medical Center.i “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.”
Coronary artery disease (CAD) is the leading cause of death globally, affecting an estimated 315 million people worldwide and approximately 1 in 20 adults over the age of 20 in the U.S.ii,iii,iv. In CAD, the buildup of cholesterol-rich deposits results in narrowing of the coronary arteries, reducing blood flow to the heart muscle. Among lesions that cannot be crossed with a balloon, more than 75% have moderate to severe calcification.v
“The FORWARD CAD IDE study shows that difficult to cross lesions may be treated successfully without compromising safety,” said James Spratt, M.D., global co-principal investigator of the study and FRCP, St. George’s University NHS Trust.[vi] “This study suggests that Javelin could help physicians manage patients with limited treatment options.”
About the FORWARD CAD Study
The FORWARD CAD study is a prospective, multicenter, single-arm study conducted in 28 sites in the U.S. and U.K. The study enrolled 158 patients with severely stenosed, de novo calcified coronary artery lesions with moderate to severe calcification defined by angiography and either over 90% stenosis with lesion length <40mm or a chronic total occlusion (CTO) and a J_CTO score of 1. The co-global principal investigators of the study are Robert Yeh, M.D., MBA, Beth Israel Deaconess Medical Center and James Spratt, M.D., FRCP, St. George’s University NHS Trust, and the U.S. principal investigator is Robert Riley, M.D., FACC, Overlake Medical Center & Clinics.
The investigational Shockwave Javelin Coronary IVL platform is designed with a single distal emitter that creates ultrasonic acoustic pressure waves, with a spherical energy field that extends beyond the tip of the catheter. This novel design enables lithotripsy delivery closer to highly stenosed calcified lesions than would be possible with balloon-based IVL platforms.
Footnotes
i Dr. Robert Yeh is a paid consultant for Shockwave Medical. He has not been compensated in connection with this press release.
ii Centers for Disease Control and Prevention. About Coronary Artery Disease (CAD). https://www.cdc.gov/heart-disease/about/coronary-artery-disease.html. Last Accessed: March 24, 2025.
iii Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html. Last Accessed: March 24, 2025.
iv https://www.jacc.org/doi/10.1016/S0735-1097%2824%2904310-9
v Salem et al. Catheter Cardiovasc Interv. 2022 Jun;99(7):2028-2037.
vi Dr. James Spratt is a paid consultant for Shockwave Medical. He has not been compensated in connection with this press release.
Find More:
Cardiovascular Ambulatory Surgery Centers (ASCs) Topic Center
Renal Denervation Topic Center
Grand Rounds With Morton Kern, MD
Peripheral Artery Disease Topic Center
