Johnson & Johnson's Shockwave Medical has announced positive clinical outcomes for its Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter, showcasing a 99% technical acute procedural success rate. The device is designed to address heavily calcified, stenotic peripheral arterial lesions in patients with peripheral artery disease (PAD).
The Shockwave Javelin Peripheral IVL Catheter is a non-balloon-based lithotripsy platform specifically engineered to modify calcium and facilitate crossing of extremely narrowed vessels. This technology offers a novel approach to treating PAD, particularly in cases where lesions are difficult to cross with conventional methods.
Clinical Trial Data
The outcomes are based on data from prospective, multi-center, single-arm trials, which were angiographic core-lab adjudicated. The studies involved 90 patients with 103 heavily calcified, stenotic peripheral arterial lesions. According to Shockwave Medical, the results supported the FDA clearance of the technology for PAD treatment.
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, stated, "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... 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."
Implications for PAD Treatment
PAD affects millions worldwide and is characterized by the buildup of plaque in the arteries, leading to reduced blood flow to the limbs. The Shockwave Javelin IVL Catheter offers a potential solution for patients with challenging lesions, providing an alternative to traditional balloon angioplasty or surgical bypass.
Nick West, MD, chief medical officer at Shockwave Medical, noted, "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."
Johnson & Johnson's Strategic Expansion
The announcement follows Johnson & Johnson's acquisition of Shockwave Medical, a move aimed at strengthening its position in the cardiovascular research space. Tim Schmid, executive vice president and worldwide chairman of Johnson & Johnson MedTech, commented on the acquisition, stating, "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."
