In an exclusive conversation with MedTech Spectrum, Dr. Arthur Lee, Director of Peripheral Vascular Services at TCAVI in Gainesville, FL, shares insights into the groundbreaking first-in-human use of FastWave Medical’s Sola™ Coronary Laser IVL System. Designed to deliver laser-guided intravascular lithotripsy with unmatched precision, Sola™ represents a next-generation approach to treating complex, calcified coronary lesions. By combining controlled energy delivery with real-time modulation, the system enables modification of both deep and superficial calcium while preserving healthy tissue. As FastWave Medical leads innovation in coronary intervention, the successful use of Sola™ highlights a significant step toward safer, more effective calcium modification—reinforcing its potential to transform outcomes in complex percutaneous coronary procedures.
What makes the SolaTM system distinct from current intravascular
lithotripsy (IVL) technologies in the coronary space?
Current intravascular lithotripsy (IVL) technologies face several limitations, including slow and restricted energy pulses, difficulty navigating heavily calcified vessels, and reduced energy availability — challenges that are especially pronounced in coronary artery disease (CAD), where small vessel size and complex anatomy require better catheter performance. These constraints can make it harder for devices to reach target lesions and effectively treat challenging calcium.
FastWave Medical set out to address these issues by developing SolaTM, a coronary laser IVL (L-IVL) system, designed for improved usability and performance, featuring:
● Laser-based energy delivery: SolaTM uses a single, translating optical emitter to create sonic pressure waves within the angioplasty balloon — eliminating multiple, bulky stationary emitters used in traditional IVL systems.
→ Unlike traditional IVL systems that generate sonic waves with electrical discharges, SolaTM uses a laser-based method — marking a fundamental shift in pressure wave generation.
● Sleek, low-profile balloon design: Removing fixed emitters significantly reduces crossing profile, improving deliverability in tortuous or highly calcified coronary vessels.
→ Legacy IVL catheters use multiple fixed emitters embedded along the length of the balloon, resulting in excess stiffness, which often make it difficult for physicians to cross tight or angulated lesions. The absence of stationary emitters in SolaTM addresses a key limitation of current IVL systems.
● Greater precision and control: Translational emitter enables more control for the treatment of multiple lesion segments, promoting unparalleled physician precision and avoiding repeated balloon deflation/re-inflation.
→ SolaTM enhances procedural efficiency and minimizes vessel trauma by reducing the multiple repositioning steps typically required with traditional IVL technology.
● True 360° circumferential sonic output: Energy is delivered circumferentially around the vessel, enabling broader, more predictable calcium modification with minimal variability across the treated lesion.
→ SolaTM offers a more uniform treatment effect compared to current IVL therapy, which produces uneven energy dispersion, potentially leaving areas of calcium untreated.
● High-frequency pulse rate (5 Hz): Offers rapid and efficient therapy delivery, helping operators treat complex lesions with more efficiency, resulting in less ischemic time for patients with compromised cardiac output.
→ Legacy IVL systems deliver pulses at just 1 Hz, often prolonging procedures and
increasing patient risk.
Can you share key insights or clinical observations from the
first-in-human procedures with SolaTM?
Early first-in-human experience highlighted several key advantages of SolaTM.
The device’s low-profile design made it easier to navigate tight or tortuous anatomy, improving deliverability where legacy IVL tools have fallen short.
The procedure also had greater efficiency — thanks to the translational feature of the emitter and the rapid 5 Hz energy delivery, long segments could be treated without balloon repositioning, streamlining the procedure and minimizing ischemic time in patients.
How does SolaTM aim to address current limitations in treating complex
coronary calcified lesions?
IVL received FDA clearance for peripheral artery disease (PAD) in 2016, followed by approval for coronary artery disease (CAD) in 2021. However, first-generation technology has its limitations — particularly in treating complex, heavily calcified coronary lesions. SolaTM is designed to overcome these constraints and optimize IVL specifically for CAD in the following ways:
● Solves deliverability challenges: The absence of bulky, stationary emitters results in a reduced balloon profile, which improves access to distal, tortuous, or severely narrowed arteries that current IVL technology struggles with.
● Increases procedural efficiency: The translating laser emitter allows continuous therapy across long segments of disease without the need to reposition the balloon.
● Delivers predictable energy: True circumferential pulses ensure uniform plaque
modification.
● Reduces ischemic time: Faster pulse delivery at 5 Hz shortens the duration of balloon inflation, limiting ischemia risk for patients with compromised cardiac output.
● Operator-centric design: Direct plug-and-play functionality, real-time monitoring, and simplified controls address procedural friction points seen with legacy IVL systems.
What is the roadmap for SolaTM in terms of regulatory approvals, broader
clinical trials, or commercialization?
FastWave recently completed initial first-in-human procedures in Uzbekistan, which is part of the multi-center feasibility study of SolaTM.
The study is evaluating Sola’s safety and performance in patients with calcified coronary artery disease.
Results will inform regulatory submissions and guide the design of a U.S. pivotal trial, paving the way for FDA approval and eventual commercialization.
How does this advancement reflect FastWave Medical's broader mission
and strategy in cardiovascular innovation?
Calcific disease is a major global health issue. Every year, coronary artery disease (CAD) causes 17.8 million deaths While IVL received FDA approval for CAD in 2021, first-generation technology comes with limitations — particularly in treating complex, heavily calcified coronary lesions.
FastWave Medical is developing the SolaTM coronary IVL system to overcome the technical limitations of legacy devices, introducing a laser-based method that marks a fundamental shift in how sonic pressure waves are generated. By eliminating multiple fixed emitters, SolaTM offers a sleeker, more deliverable balloon catheter that physicians find easier to navigate through tight or tortuous vessels.
Its translating emitter allows for precise, physician-controlled energy delivery across long lesion segments with consistent 360° calcium modification, while the rapid 5 Hz pulse rate improves procedural efficiency and reduces ischemic time — making treatment faster, more predictable, and less demanding for clinicians.
Chaitrali Gajendragadkar
chaitrali.gajendragadkar@mmactiv.com
Senior Officer - Media Integrations
MedTech Spectrum
www.medtechspectrum.com
