Tag: intravascular lithotripsy
Shockwave Javelin peripheral IVL catheter meets prespecified efficacy and safety performance...
Shockwave Medical, part of Johnson & Johnson MedTech, has announced the first clinical outcomes associated with the Shockwave Javelin peripheral intravascular lithotripsy (IVL) catheter,...
Bolt Medical announces completion of RESTORE ATK and RESTORE BTK pivotal...
Bolt Medical has announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the company's Bolt intravascular lithotripsy...
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....
CIRSE begins CALCIO trial enrolment for treatment of CLTI with Shockwave...
The Cardiovascular and Interventional Society of Europe (CIRSE) have announced that patient enrolment for the CALCIO trial has begun. CALCIO started patient enrolment on...
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...
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...
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 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...
CMS creates new codes for IVL performed below the knee
Shockwave Medical has announced that as part of the calendar year 2021 Medicare Hospital Outpatient Prospective Payment System (OPPS) final rule, the Centers for...
Intravascular lithotripsy ‘superior’ to PTA in acute procedural success out to...
The DISRUPT PAD III randomized controlled trial (RCT) provides the largest level-one evidence for the treatment of heavily calcified femoropopliteal arteries, noted William Gray,...
Shockwave Medical announces new CMS codes for intravascular lithotripsy
Shockwave Medical has announced new Centers for Medicare & Medicaid Services (CMS) codes for intravascular lithotripsy (IVL), a procedure performed in peripheral arteries in...