Shockwave shared the first clinical outcomes associated with its Javelin peripheral intravascular lithotripsy (IVL) catheter system. It designed this novel, non-balloon-based lithotripsy platform to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD).
At the start of the year — and prior to Johnson & Johnson’s $13 billion acquisition of Shockwave — the company outlined its hopes for Javelin. Former CEO Doug Godshall said it offers an alternative to the company’s currently available balloon-based platform. Godshall said Javelin “sort of shifts the energy to the front of the catheter for really difficult-to-cross lesions, which is a subset of patients we just really can’t treat today.”
Javelin features a single 120-pulse lithotripsy emitter at the distal tip of the catheter. The company designed it for use in sub-total occlusions or extremely narrowed vessels in which a wire will cross but devices will not. With this new platform, the sonic pressure waves expand spherically from the forward-shifted emitter beyond the tip of the catheter, allowing modification of the obstructive calcification that facilitates device crossing.
Shockwave IVL meets endpoints
Shockwave reported that 30-day results met both prespecified performance goals and showed a similar safety and effectiveness profile to the balloon-based Shockwave IVL catheters. Results helped support FDA clearance for the technology last month, the company said.
Javelin met both prespecified safety and effectiveness endpoints. It produced a major adverse event rate of 1.1% at 30 days with a technical acute procedural success rate of 99%. Additionally, at final angiography, angiographic complications were restricted to a single case of dissection with no reported perforations, abrupt vessel closure, distal embolization or no-reflow.
Shockwave reported the outcomes from both the MINI S feasibility and FORWARD PAD investigational device exemption (IDE) studies. They enrolled 90 patients with 103 heavily calcified, stenotic peripheral arterial lesions.
“Recognizing the risks that patients with difficult-to-cross lesions are exposed to with other treatment modalities, we’re extremely optimistic about the role that Shockwave Javelin could play in offering an effective alternative crossing and treatment tool with a strong safety profile,” said Dr. Nick West, chief medical officer at Shockwave Medical. “We look forward to learning more about the performance of the Shockwave Javelin IVL catheter as we add to the ongoing trial follow-up data with a limited market release of the device in the coming months.”
More IVL data
Shockwave also reported the 30-day primary endpoint of the DISRUPT BTK II study. The post-market study assesses the continued safety, effectiveness and optimal clinical use of its peripheral IVL system for the treatment of calcified peripheral lesions below the knee (BTK), including some of the most challenging patients with critical limb threatening ischemia (CLTI).
Dr. Venita Chandra and Dr. Ehrin Armstrong led the prospective, multi-center, core-lab adjudicated, single-arm study. It enrolled 250 patients with 305 lesions across 38 sites globally. Shockwave said the complex patient population included 46% of patients presenting with baseline wounds, 80% with CLTI, 70% with diabetes mellitus, 30% with chronic total occlusions (CTOs) and 85% with moderate-to-severe calcium.
The study met its primary effectiveness endpoint of procedural success with a rate of 97.9% residual stenosis for all treated target lesions without serious angiographic complications. It met the primary safety endpoint, too, with a rate of 0.8% absence of major adverse limb events (MALE) or post-operative death (POD) within 30 days of the index procedure.
Within 30 days, 49% of treated limbs already improved from their RC baseline. Patients showed a statistically significant improvement in VascuQol scores, as well.
“Patients will now be followed in the study out to two years to assess the long-term durability of the compelling 30-day data in this difficult-to-treat patient population,” said Armstrong. “With both new IVL devices at our disposal and new data to interpret, I look forward to the additional analyses and learning about the optimal use of IVL to help improve outcomes in these difficult to treat patients.”
