The Institutional Review Board (IRB) has granted approval for FastWave Medical to initiate a coronary feasibility study leveraging its Sola laser intravascular lithotripsy (L-IVL) system.
This pivotal development is in collaboration with contract research organisation (CRO) Clinical Accelerator and is a precursor to a planned US pivotal trial.
FastWave noted that its L-IVL system is designed to aid physicians in treating cardiovascular calcium with rupture-resistant, sleek balloon catheters.
It features a custom laser energy source that generates consistent circumferential sonic pressure waves. This solution enables operator control to safely modify calcium.
Additionally, the company is preparing to initiate a US investigational device exemption (IDE) pivotal trial for treating peripheral artery disease with the Artero electric IVL (E-IVL) system within the year.
FastWave CEO and co-founder Scott Nelson said: “Our committed team is aiming to set a new standard in the IVL category, enabling physicians to achieve best-in-class clinical outcomes.
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By GlobalData鈥淭his IRB approval represents a major milestone in our mission to deliver transformative technology to physicians and their patients.鈥�
FastWave鈥檚 technologies are said to address limitations in current calcium-modification approaches, offering improved deliverability, usability, and energy output.
The company’s IVL technologies claim to transform the calcific artery disease treatment in coronary and peripheral applications.
FastWave Medical has so far obtained more than聽$40m聽in venture funding, offering support to its dual-platform IVL technology advancement.
In December 2024, FastWave Medical was granted its sixth utility patent by the US Patent and Trademark Office (USPTO), the fourth in that year, adding to the company鈥檚 intellectual property IVL portfolio
Clinical Accelerator is said to specialise in medical device studies, offering early entry into the clinic, ensuring rapid implementation of early feasibility studies (EFS) and first-in-human (FIH) studies. The CRO is collaborating with companies of all sizes to help offer solutions to global patients.
