IGMPI facebook J&J Launches Shockwave Javelin Catheter; Medtronic Initiates HFpEF Pacemaker Trial
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J&J Launches Shockwave Javelin Catheter; Medtronic Initiates HFpEF Pacemaker Trial

J&J Launches Shockwave Javelin Catheter; Medtronic Initiates HFpEF Pacemaker Trial

Johnson & Johnson (J&J) has launched the Shockwave Javelin intravascular lithotripsy (IVL) catheter in Europe to treat patients with peripheral artery disease (PAD). The device uses sound pressure waves to break up calcified lesions in severely narrowed vessels, addressing technical challenges in complex cases. The Javelin platform, featuring a single lithotripsy emitter behind the catheter tip, shows a safety and effectiveness profile comparable to balloon-based Shockwave IVL catheters. J&J also initiated the FORWARD CAD investigational study in April to evaluate the device in difficult-to-cross, calcified coronary lesions, enrolling up to 158 patients across 35 U.S. and U.K. sites. J&J acquired Shockwave Medical for $13.1 billion in 2024.

Separately, Medtronic has launched the ELEVATE-HFpEF pivotal trial to assess pacemaker therapy in patients with heart failure with preserved ejection fraction (HFpEF), a condition affecting roughly 32 million people globally. The randomized, double-blind study will enroll up to 700 participants across multiple regions, aiming to expand pacing indications for patients with limited treatment options.

21-09-2025