FastWave Medical Unveils Artero: The Fastest IVL System at 4 Hz, Announces PIs for Upcoming IDE Trial

Oct 03, 2025 22:15 CST Updated 22:15

Johnson & Johnson

Medical Device R&D and Manufacturer

FastWave MedicalAnnounced the appointment of itsFastest Treatment Speed IVL---ArteroThe Principal Investigator of the IDE Clinical Trial (Columbia University Irving Medical CenterSahil Parikh withStanford Health CareVenita Chandra), and is about to launch the IDE clinical study.

ArteroYesFastWave MedicalOne of the two major IVL technology platforms under development (the other isSola (Laser-based IVL Technology) has initiated IDE clinical research for the treatment of coronary arteries.). It is a high-frequency IVL technology.

FastWave MedicalThe reason for developing two technology platforms, in addition to clinicalApplicationDifferent from, also isFastWave MedicalBetting on Two I'sVL Technology School. By developing two different IVL technologies, it maintains competitiveness in an increasingly competitive environment.

Currently, Johnson & Johnson remains the leader in the IVL field.One company dominates the market. In addition to its balloon-shaped IVL, it has also launched a non-balloon-shaped forward shock wave catheter, which has already been marketed. Additionally, Boston Scientific acquired Bolt Medical for $664 million at the beginning of the year, and in April, its device for peripheral treatment...Bolt IVL Receives FDA Approval for Market Launch. In addition, Abbott,Companies such as AVS, Elixir Medical, and Vantis Vascular are also actively positioning themselves. Therefore, to survive in this highly competitive market, having unique technology is essential.

Executive Evaluation

"One of Artero's core objectives is to provide doctors with a system that combines speed, simplicity, and reliability, enabling them to treat various calcified lesions with greater confidence and precision."

---Scott Nelson FastWave MedicalChief ExecutiveOfficial

PI Evaluation

"The key is not only whether the device is effective, but also whether it can improve surgical efficiency and provide doctors with a more reliable means to treat complex arterial diseases," Chandra pointed out, "I look forward to validating the clinical potential of the FastWave Peripheral IVL System in this study."

---Venita Chandra Stanford Health Care

Artero

ArteroIs aBalloon with 4 Hz frequency emitting circumferential acoustic pressure wavesIts speed is twice that of traditional IVL devices.ArteroThe adopted anti-rupture balloon and low-profile design simplify the procedure and maintain reliable performance, even in complex lesions.

Artero Advantages

Seamless Operation Experience

One-touch start, real-time feedback, hands-free operation, no cable connection required. Artero simplifies peripheral intravascular lithotripsy — allowing interventional physicians to focus on patients rather than cumbersome cables.

Excellence Through Performance

Artero, with a smaller outer diameter and an optimized delivery shaft design, is specifically engineered for challenging anatomical pathways. The rupture-resistant balloon we are developing aims to provide stable treatment outcomes even when facing complex vasculature.

Efficient and Predictable Treatment

Artero Adopts Innovative Emitter Design to Deliver Sound Pressure Waves at 4 Hertz – Twice the Speed of Existing IVL Technology. Each Catheter Can Release More Pulses, Providing Predictable Treatment Outcomes for Doctors Through Continuous Longitudinal and Circumferential Energy Output.

Artero FIM Study(9 successfully treated limbs, 16 target femoral-popliteal artery lesions, 99% moderate to severe calcified lesions)

100% lesion passage rate (including 3 cases of CTO)
5.9% Average Residual Diameter Stenosis Rate
0% Major Adverse Reactions (No Balloon Rupture Cases)

Artero Demonstration

FastWave Medical

FastWave MedicalIt is a private company incubated by Big Sky Biomedical partners, focusing on providing simple, safe, and effective endovascular solutions for arterial diseases.