FastWave Medical today announced successful 30-day results from the first-in-human study of its intravascular lithotripsy (IVL) technology.
Minneapolis-based FastWave develops laser-based IVL technology for treating calcific artery disease. Its platform offers durable and fast energy delivery with enhanced sonic output. The system helps to navigate complex arterial anatomy through a high-performing catheter.
IVL is a hot space, with Johnson & Johnson’s recent $13.3 billion acquisition of Shockwave Medical highlighting that.
FastWave kicked off its first-in-human study kicked off earlier this year. The prospective, single-arm study aims to assess the IVL system’s safety and feasibility in patients with peripheral arterial disease (PAD) affecting the superficial femoral artery (SFA) and popliteal artery with moderate to severe calcium.
According to a news release, investigators successfully treated eight patients with moderate to severe calcified occlusions in the SFA and popliteal arteries. Evidence supported early safety and feasibility of the IVL system. Findings included 100% procedural success and 0% peri-procedural adverse events. FastWave reported 5.9% mean residual diameter stenosis post-therapy.
At 30 days, the company also reported zero major adverse events, 100% patency and 0% revascularization. Patients recorded improved walking distance and speed and stair-climbing ability. Ankle-brachial index (ABI) improved from baseline 0.56 to 0.89, noting enhanced blood flow.
“The procedural data from the initial intervention and the 30-day results reinforce our confidence in the FastWave IVL system’s potential to pave the way for a peripheral pivotal trial in the U.S.,” said Scott Nelson, co-founder and CEO of FastWave. “On behalf of the rest of our team, I’d like to express our sincere gratitude to the Principal Investigators for their exceptional clinical work and collaboration with the FastWave team in sharing these 30-day data.”
