J&J Launches IVL Device in Europe as Medtronic Explores New Pacing Approach for Heart Failure

Johnson & Johnson (J&J) and Medtronic have announced significant developments in their respective cardiovascular device portfolios, addressing critical needs in peripheral artery disease (PAD) and heart failure treatment.

J&J Introduces Shockwave Javelin IVL Catheter in Europe

J&J has launched its Shockwave Javelin intravascular lithotripsy (IVL) catheter in Europe, targeting patients with peripheral artery disease. The device employs sound pressure waves to break down calcium deposits in severely narrowed blood vessels, addressing a persistent challenge in complex below-the-knee (BTK) revascularization procedures.

The Javelin platform features a single lithotripsy emitter positioned behind the catheter tip, maintaining a safety and effectiveness profile comparable to balloon-based Shockwave IVL catheters. Dr. Narayanan Thulasidasan, a consultant interventional radiologist at Guy's and St Thomas' NHS Foundation Trust in London, highlighted the device's potential to overcome "device-uncrossable" calcified lesions, a significant barrier in complex BTK interventions.

J&J is also conducting the FORWARD CAD study, an investigational device exemption trial initiated in April, to evaluate the Javelin catheter's safety and efficacy in treating difficult-to-cross, calcified coronary lesions. This prospective, single-arm study aims to enroll up to 158 patients across approximately 35 sites in the U.S. and U.K.

The introduction of the Shockwave Javelin IVL catheter follows J&J's $13.1 billion acquisition of Shockwave Medical in 2024, solidifying the company's position in the cardiovascular device market.

Medtronic Initiates Pivotal Study on Cardiac Pacing for HFpEF Patients

Medtronic has launched a pivotal study to explore the potential of cardiac pacing in heart failure patients with preserved ejection fraction (HFpEF). This condition, characterized by heart stiffening and reduced blood flow, affects approximately 32 million people globally and accounts for about 50% of all heart failure diagnoses.

The ELEVATE-HFpEF trial aims to evaluate the efficacy of pacing therapy in HFpEF patients who currently have limited treatment options. This randomized, double-blinded study will enroll up to 700 participants across North America, Europe, the Middle East, Africa, Australia, and the Asia Pacific region. Notably, the study will include patients who do not have a current indication for pacing.

Participants will receive a commercially available Medtronic pacemaker along with SelectSecure MRI SureScan pacing leads. The company intends to use the study results to pursue a new pacing indication for HFpEF patients, potentially expanding the application of this established cardiac rhythm management technology.

By exploring this novel approach, Medtronic aims to address a significant unmet need in heart failure treatment, potentially offering new hope to millions of patients worldwide who struggle with HFpEF.