Javelin Forward Shockwave Catheter One-Year Clinical Data: 99% of Patients Limb Salvage Rate Demonstrated in FORWARD PAD IDE Study

Johnson & Johnson inAnnounced at the VIVA2025 ConferenceAnterior Shock Wave Catheter---One-Year Follow-Up of JavelinIDEClinical research data (FORWARD PAD). The results showed that patients treated with Javelin had lower rates of major amputations and cardiovascular death.

The FORWARD PAD study enrolled a total of 110 patients, with 124 lesions assessed by the core laboratory. The 12-month endpoints included major adverse events (MAE), cardiovascular death, clinically driven target lesion revascularization (CD-TLR), unplanned major amputation of the target limb, and patency.

Baseline lesion characteristics showed: 83.9% had severe calcification, diameter stenosis rate was 83±17.4%, and 41.7% were CTO lesions. Final angiographic results revealed an acute lumen gain of 2.8±1.2mm, residual stenosis rate of 23.1±8.6%, with only one case of Type D dissection.

Specific Research Data

• The overall MAE incidence rate at 12 months was 18.6% (19/102).

• Major amputation rate remains low: 1.0% at 12 months in the target limb.

• Cardiovascular Mortality Remains at a Low Level: One-Year Cardiovascular Mortality Rate is 3.9%

• The incidence rate of clinically-driven target lesion revascularization (CD-TLR) was 14.7%.

• Excellent performance in sustained patency:

• One-year primary patency rate of ATK lesions was 72.7%, primary-assisted patency rate was 74.5%, and secondary patency rate was 76.4%.

• The primary patency rate of below-the-knee (BTK) lesions was 61.5%, the primary assisted patency rate was 78.4%, and the secondary patency rate was 88.6%.

PI Evaluation

"These one-year results demonstrate the durable efficacy stability of the Shockwave Javelin catheter, with most patients not requiring repeat interventions. Severe calcification has always been one of the biggest challenges in endovascular treatment for PAD, leading to high rates of complications, mortality, and limb loss. Clinicians have long lacked technologies that can safely modify calcified lesions to achieve passage through severely narrowed sites. These results confirm that IVL technology not only overcomes this barrier but also redefines treatment possibilities, creating optimized outcomes for a broader population of PAD patients."

---JD Corl   The Lindner Center for Research and Education 

"For severe calcification with severe stenosis or total occlusion, Javelin can effectively reduce stenosis and achieve acute lumen gain without perforation or embolization, consistent with previous balloon-based IVL study results. The one-year patency rate, amputation rate, and revascularization rate are comparable to prior clinical trial data for severe calcification lesions."

---Andrew Holden   Auckland City Hospital

Executive Evaluation

"These one-year data reinforce our confidence in the Javelin catheter as a safe and effective solution for modifying and crossing complex PAD lesions. The sustained benefits we have observed—particularly in severely calcified, difficult-to-cross lesions—mark a fundamental shift in how clinicians approach these cases. We will continue to drive innovation and expand treatment options to improve outcomes for PAD patients."

---Nick West Chief Medical Officer of Shockwave Medical

JavelinIt is a new type of shockwave catheter, which is different from traditional balloon-type shockwave catheters primarily because it has no balloon andThe shock wave generator is set at the distal end of the catheter, thereby achievingTransmit shock waves to the front of the catheter and use shock waves to open the occluded blood vessel.

• The pressurized chamber can be filled with saline to achieve the predetermined treatment pressure.

• Flushing the catheter lumen allows for irrigation of the treatment area with saline solution.

• The guidewire lumen is used for passing through aA 0.014" (0.36 mm) guidewire to facilitate passage through occluded vessels under guidewire guidance.