Johnson & Johnson’s Shockwave Medical Shares First Clinical Outcomes Associated With its IVL Catheter
Trial data over 30 days showed the novel Intravascular Lithotripsy catheter safely modified calcium, enabling effective treatment.
Shockwave Medical, part of Johnson & Johnson MedTech, has announced the first clinical outcomes associated with the novel Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter. Results across multiple studies showed the catheter met prespecified safety and effectiveness endpoints, highlighted by a technical acute procedural success rate of 99%.1
The Shockwave Javelin Peripheral IVL Catheter is a non-balloon-based lithotripsy platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD).
In a press release, JD Corl, MD, FACC, FSCAI, medical director of the PAD/CLI program at The Lindner Center for Research and Education at The Christ Hospital and principal investigator of FORWARD PAD Study said, "The outcomes were exactly what we have come to expect from IVL studies - a strong safety profile with the low final residual stenosis that physicians would hope to achieve. These new initial data are promising and pave the way for a new approach to the application of Shockwave IVL in our peripheral practices. With technologies now suited to safely address both crossable and uncrossable lesions, IVL has a unique opportunity to play an increasingly important role in optimizing outcomes for a wider set of patients with PAD."
Both studies of the Shockwave Javelin Peripheral IVL Catheter were prospective, multi-center, single-arm, angiographic core-lab adjudicated trials. Across both studies, 90 patients with 103 heavily calcified, stenotic peripheral arterial lesions were enrolled.
According to Shockwave, these results helped support FDA clearance of the technology for patients with PAD last month.
"Recognizing the risks that patients with difficult-to-cross lesions are exposed to with other treatment modalities, we're extremely optimistic about the role that Shockwave Javelin could play in offering an effective alternative crossing and treatment tool with a strong safety profile," Nick West, MD, chief medical officer at Shockwave Medical added in the press release. "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."
Results from the Shockwave Javelin Peripheral IVL Catheter come just months after Johnson & Johnson announced its acquisition of Shockwave. The transaction extended Johnson & Johnson MedTech’s leadership in the cardiovascular research space.2
In a press release from May, Tim Schmid, executive vice president and worldwide chairman of Johnson & Johnson MedTech, said, “Completing this acquisition is a significant milestone in the expansion of our leadership position in the medtech industry. Shockwave’s differentiated solutions and robust pipeline represent an exciting opportunity for Johnson & Johnson MedTech to bring more innovations to patients in one of the largest areas of unmet medical need. We are excited to begin collaborating directly with the Shockwave team and look forward to a bright future together.”
References
1. Shockwave Medical Unveils First Clinical Outcomes of New IVL Platform in Late-Breaking Presentation at VIVA 2024. News release. Shockwave Medical. November 4, 2024. Accessed November 6, 2024. https://shockwavemedical.com/about/press-releases/shockwave-medical-unveils-first-clinical-outcomes-of-new-ivl-platform-in-late-breaking-presentation-at-viva-2024/
2. Johnson & Johnson Completes Acquisition of Shockwave Medical. News release. Johnson & Johnson. May 31, 2024. Accessed November 6, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-completes-acquisition-of-shockwave-medical
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