Shockwave’s Javelin IVL Catheter Evaluated in Pooled Data From Mini S Feasibility and FORWARD PAD IDE Studies

November 4, 2024—The first clinical use of the Javelin peripheral intravascular lithotripsy (IVL) catheter (Shockwave Medical) for the treatment of peripheral artery disease (PAD) was evaluated in pooled data from the premarket, prospective, single-arm Mini S feasibility study and the FORWARD PAD investigational device exemption (IDE) study. The Javelin device features a forward-shifted IVL emitter designed to modify calcium in subtotal occlusions or extremely narrowed calcified vessels.

JD Corl, MD, presented the findings in the first late-breaking clinical trials session at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

According to the VIVA24 press release, this pooled analysis included 103 lesions in 90 patients treated at 19 sites in Australia, New Zealand, and the United States. The primary effectiveness endpoint was defined as residual stenosis ≤ 50% without flow-limiting dissection at final angiography. The primary safety endpoint was major adverse events at 30 days. Endpoints were adjudicated by an angiographic core laboratory and a clinical events committee.

Lesion characteristics included preprocedural stenosis of 82.9% ± 16.7%; severe calcification present in 82.5%; and 38% chronic total occlusions.

As reported at VIVA24, the Javelin catheter was able to fully cross the target lesion in 93% of cases. The prespecified performance goals were met with both the primary effectiveness endpoint (99%; P < .0001) and the primary safety endpoints (1.1%; P = .0012). Baseline stenosis was reduced to 23% ± 9.1% at final angiography, and there were no perforations or embolization events through 30 days.

Further follow-up will assess longer-term outcomes with the Javelin peripheral IVL catheter, noted the VIVA24 press release.