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FastWave Medical Announces Successful 30-Day Results From First-in-Human Study of Advanced Peripheral IVL System
FastWave's peripheral IVL platform showcases promising 30-day results in the first-in-human study demonstrating safety and feasibility in patients with moderate to severe calcified obstructive disease in the superficial femoral and popliteal arteries.
FastWave's peripheral IVL platform showcases promising 30-day results in the first-in-human study demonstrating safety and feasibility in patients with moderate to severe calcified obstructive disease in the superficial femoral and popliteal arteries.
MINNEAPOLIS -- FastWave Medical, a clinical-stage medical device company developing advanced intravascular lithotripsy (IVL) technology, is pleased to announce the successful 30-day results of its first-in-human (FIH) study using the company's differentiated peripheral IVL technology.
This was a prospective, single-arm study to assess the safety and feasibility of the FastWave IVL system in patients with peripheral arterial disease affecting the superficial femoral artery (SFA) and popliteal artery with moderate to severe calcium. Principal investigators Dr. Miguel Montero-Baker from HOPE Vascular & Podiatry Clinic, Houston, TX, and Dr. Venkatesh Ramaiah from HonorHealth Vascular Group and Pulse Cardiovascular Institute, Scottsdale, AZ, successfully conducted the procedures in collaboration with the hosting investigator, Dr. Antonio Muñoa at San Lucas Hospital, Chiapas, Mexico.
Eight patients with moderate to severe calcified occlusions in the SFA and popliteal arteries were successfully treated, providing encouraging evidence supporting the early safety and feasibility of the FastWave IVL system.
Key procedural findings include:
- 100% procedural success
- 0% peri-procedural adverse events
- 5.9% mean residual diameter stenosis post-therapy
30-day results include:
- 0% major adverse events
- 100% patency, <2.4 Peak Systolic Velocity Ratio (PSVR)
- 0% revascularization
- Walking Impairment Questionnaire (WIQ) scores showed improved walking distance and speed, and stair-climbing ability
- Ankle-brachial index (ABI) improved from baseline 0.56 to 0.89 at 30 days noting enhanced blood flow
Dr. Montero-Baker approved these results, stating, "The overall improvement in the patients treated in the FastWave FIH study is really encouraging and provides compelling evidence supporting the feasibility and safety of the FastWave IVL system for further evaluation in a larger patient population in the U.S."
Dr. Ramaiah added, "I am impressed by the performance of the FastWave peripheral IVL catheter – it's both highly deliverable and easy to use. Achieving a 94% mean percent residual diameter stenosis reduction at the end of the procedure is equally impressive and the 30-day follow-up results reinforce the initial procedure's success."
Scott Nelson, co-founder and CEO of FastWave Medical, shared his excitement, "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. 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."
About FastWave Medical Inc.
FastWave Medical is at the forefront of developing intravascular lithotripsy (IVL) systems for calcific artery disease. With an emphasis on empowering physicians with procedural efficiency, FastWave aspires to redefine the sector by introducing next-generation IVL technologies that elevate the clinician experience and overall patient care. For more insights, please visit https://fastwavemedical.com.
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