Shockwave Medical launches new IVL catheter for targeting challenging lesions in PAD patients
Shockwave Medical, a Johnson & Johnson MedTech company, has officially launched its Javelin Peripheral IVL Catheter, a new-look intravascular lithotripsy (IVL) device built to target calcium in the extremely narrowed blood vessels of patients with peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI).
The Javelin Peripheral IVL Catheter is 150 cm long and features a single distal emitter capable of creating up to 120 shockwave pulses. In addition, its balloon-free design helps get deliver those pulses closer to calcified lesions than balloon-based IVL catheters.
“Physicians have faced significant challenges in tackling complex calcific lesions in narrowed peripheral vessels, and there is a growing need for more effective crossing and treatment tools,” J.D. Corl, MD, interventional cardiologist and medical director of the PAD/CLI program at The Lindner Center for Research and Education at The Christ Hospital, said in a statement. “With proven safety and effectiveness similar to existing IVL devices, Shockwave’s new IVL platform will bring a transformative approach to our peripheral practices, enabling us to make cases more efficient and optimize outcomes for our patients living with PAD, especially those with more complex CLTI.”
Launch follows positive data presented at VIVA 2024
Shockwave presented positive data on the Javelin at VIVA 2024 in Las Vegas, noting that it was associated with a technical acute procedural success rate of 99% and major adverse event rate of just 1.1% after 30 days. Only one complication occurred, the company noted, and there were no reports of perforations, abrupt vessel closure, distal embolization or no-reflow.
“We look forward to learning more about the performance of the Shockwave Javelin IVL catheter as we add to the ongoing trial follow-up data with a limited market release of the device in the coming months,” Nick West, MD, Shockwave's chief medical officer, said at the time.
A closer look at the Javelin Peripheral IVL Catheter
When Shockwave introduced the Javelin to attendees at TCT 2024, Cardiovascular Business spoke to Corl about what makes it stand out. He emphasized the importance of the device’s single emitter, which was developed to cross lesions that have previously been especially difficult for even the most talented cardiologists to get through. Another benefit of treating PAD and CLTI patients with the Javelin, he said, was the reduced risk of trauma.
Click here for the full video interview.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.