Tag: IVL

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...

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...

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...

More research needed but lithotripsy plus TCAR ‘an answer’ in certain...

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...

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...

Initial case series indicates lithotripsy can help TCAR expand into high-risk...

Lithotripsy may hold the key to enabling more carotid artery disease patients who require calcification treatment to undergo stent placement via a transcarotid artery...

Disrupt PAD III observational study results confirm safety and effectiveness of...

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...

Shockwave IVL maintains ‘superiority’ to angioplasty in calcified peripheral disease at...

Shockwave Medical announced today that long-term data from the Disrupt PAD III trial found that superior vessel preparation with intravascular lithotripsy (IVL) led to excellent long-term outcomes...

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...

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...

First patient enrolled in Disrupt BTK II study for long, calcified,...

Shockwave Medical has announced the start of the Disrupt BTK II postmarket study to assess the safety, effectiveness and optimal clinical use of the Shockwave...

VIVA 2021: IVL ‘consistently’ treats real-world calcium in multiple peripheral vessel...

An interim analysis from the DISRUPT PAD III observational study showed that intravascular lithotripsy (IVL) performs “consistently well” across challenging peripheral vessels, lesions and...