Johnson & Johnson said this week it launched the Shockwave Javelin intravascular lithotripsy catheter in Europe to treat patients with peripheral artery disease.
The device, which uses sound pressure waves to break up calcium deposits in extremely narrowed vessels, is designed to address technical barriers in complex cases.
The Javelin platform, which includes a catheter with a single lithotripsy emitter placed behind the tip of the device, has a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters, J&J said.
“The Shockwave Javelin Peripheral IVL catheter helps address one of the most persistent technical barriers in complex below the knee (BTK) revascularization – the ‘device-uncrossable’ calcified lesion,” Narayanan Thulasidasan, consultant interventional radiologist at Guy’s and St Thomas’ NHS Foundation Trust in London, said in J&J’s statement.
In April, J&J began an investigational device exemption study to assess the safety and effectiveness of the Javelin catheter in difficult-to-cross, calcified coronary lesions. The prospective, single-arm FORWARD CAD study will enroll up to 158 patients at about 35 sites in the U.S. and U.K.
J&J acquired Shockwave Medical for $13.1 billion in 2024.
Medtronic studies new pacing approach
Medtronic has begun a pivotal study of cardiac pacing in heart failure patients with preserved ejection fraction, or HFpEF.
The condition, in which the heart stiffens and reduces blood flow, comprises about 50% of all heart failure diagnoses, affecting about 32 million people globally, the company said.
A pacemaker is a standard treatment to help restore normal heart rhythm in patients with a slow heart rate. Medtronic plans to use the study results to pursue a new pacing indication for people with HFpEF who have limited treatment options.
The ELEVATE-HFpEF trial will enroll up to 700 people across North America, Europe, the Middle East, Africa, Australia and the Asia Pacific region who do not have a current indication for pacing. Participants in the randomized, double-blinded study will get a commercially available Medtronic pacemaker and SelectSecure MRI SureScan pacing leads.
