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Pulse IVL system US pivotal trial enrolls first patient
Amplitude Vascular Systems (AVS) recently announced that it has enrolled the first patient in its U.S. pivotal trial for pulsatile intravascular lithotripsy (IVL) therapy. A press release notes that the POWER PAD II clinical study will evaluate the safety and…
Shockwave Medical expands US peripheral IVL portfolio with enhanced catheter
Shockwave Medical, part of Johnson & Johnson MedTech, has announced the full U.S. launch of its Shockwave E8 peripheral intravascular lithotripsy (IVL) catheter, following clearance by the Food and Drug Administration (FDA). A company press release details that the Shockwave…
CIRSE begins CALCIO trial enrolment for treatment of CLTI with Shockwave IVL system
The Cardiovascular and Interventional Society of Europe (CIRSE) have announced that patient enrolment for the CALCIO trial has begun. CALCIO started patient enrolment on 15 July, 2024, with the goal of recruiting 400 chronic limb-threatening ischaemia (CLTI) patients over the…
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…
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…