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AVS receives IDE approval from FDA for pivotal intravascular lithotripsy study
Amplitude Vascular Systems (AVS) announced today that it has received an investigational device exemption (IDE) from the Food and Drug Administration (FDA) to begin its pivotal trial for pulsatile intravascular lithotripsy (IVL) therapy. The POWER-PAD-II clinical study will evaluate the…
FastWave Medical announces successful 30-day first-in-human data on peripheral IVL technology
FastWave Medical has announced the 30-day results of its first-in-human (FIH) study using the company’s differentiated peripheral intravascular lithotripsy (IVL) technology. This was a prospective, single-arm study to assess the safety and feasibility of the FastWave IVL system in patients…
First procedures announced in study of novel peripheral IVL system
FastWave Medical has announced the successful completion of enrollment for its first-in-human (FIH) study with the company’s peripheral intravascular lithotripsy (IVL) technology. The prospective, single-arm study aims to assess the safety and performance of FastWave’s IVL system in patients with…
More research needed but lithotripsy plus TCAR ‘an answer’ in certain carotid disease patients
Earlier this year, researchers debuted single-center experiences indicating that intravascular lithotripsy (IVL) may be able to expand transcarotid artery revascularization (TCAR) into patients with traditionally prohibitive calcific disease. With a multicenter case series now further suggesting IVL’s utility, but also…
Adding 8–12mm diameter devices to the Shockwave Peripheral Intravascular Lithotripsy toolkit
This advertorial is sponsored by Shockwave Medical. Mazin Foteh, MD, contrasts the benefits of Shockwave Medical’s new Shockwave L6 Peripheral Intravascular Lithotripsy Catheter alongside those of its sister device, the Shockwave M5+ Peripheral Intravascular Lithotripsy Catheter. The Shockwave L6 device…
Initial case series indicates lithotripsy can help TCAR expand into high-risk patients
Lithotripsy may hold the key to enabling more carotid artery disease patients who require calcification treatment to undergo stent placement via a transcarotid artery revascularization (TCAR) procedure, as per single-center experiences presented at the recent Society for Clinical Vascular Surgery…
Shockwave Medical announces US launch of new peripheral IVL catheter
Shockwave Medical announced the full U.S. commercial availability of the Shockwave L6 peripheral intravascular lithotripsy (IVL) catheter following clearance by the Food and Drug Administration (FDA). A press release details that the Shockwave L6 catheter is purpose-built to modify calcification in otherwise difficult-to-treat…
Disrupt PAD III observational study results confirm safety and effectiveness of IVL in complex calcified lesions
The final 1,373-patient cohort analysis from the Disrupt PAD III observational study (OS) demonstrates consistent intravascular lithotripsy (IVL; Shockwave Medical) outcomes in complex and challenging lesions across multiple peripheral vessel beds. Ehrin Armstrong, MD, from an interventional cardiologist from Adventist…
Shockwave Medical announces global launch of new peripheral IVL catheter
Shockwave Medical has announced the global commercial availability of the Shockwave M5+ peripheral intravascular lithotripsy (IVL) catheter after receiving both Food and Drug Administration (FDA) and CE mark clearance. A company press release details that the Shockwave M5+ catheter is specifically designed to…
CSI announces development of IVL technology for the treatment of PAD
Cardiovascular Systems (CSI) recently announced that it has made significant progress towards the commercialization of its intravascular lithotripsy (IVL) system for the treatment of calcific peripheral arterial disease (PAD). A company press release notes that feasibility testing of a proprietary…