FastWave Medical earned FDA investigational device exemption (IDE) approval for its next-generation intravascular lithotripsy (IVL) technology, the company announced today. The approval clears the company to begin a U.S. pivotal trial of its Artero electric IVL system designed to treat peripheral artery disease. "Reaching IDE approval takes a … [Read more...] about FastWave Medical earns FDA IDE approval for next-gen IVL system
IVL
Abbott is making an IVL play with FDA IDE nod
Abbott announced today that it received FDA investigational device exemption (IDE) approval for its coronary intravascular lithotripsy (IVL) system. IDE enables the company to evaluate the system in treating severe calcification in coronary arteries prior to stenting. The company expects its TECTONIC coronary artery disease (CAD) IVL trial to … [Read more...] about Abbott is making an IVL play with FDA IDE nod
AVS is developing a new method of intravascular lithotripsy
Amplitude Vascular Systems (AVS) is working on a new way to treat severely calcified arterial disease. The name of the company’s peripheral intravascular lithotripsy (IVL) system is Pulse. The Boston-based startup could start enrolling patients in an investigational device exemption (IDE) study as soon as next year. AVS Chief Operating … [Read more...] about AVS is developing a new method of intravascular lithotripsy
