After launching its latest intravascular lithotripsy catheter designed to punch through difficult blockages in the vessels of the legs, Johnson & Johnson MedTech’s Shockwave Medical division is now studying the same approach in the arteries of the heart.
The company began rolling out its Javelin system early last month for peripheral artery disease, with a device that emits sonic pressure waves forward from its tip—instead of around its circumference, as in its previous platforms—to crack calcium deposits that line the blood vessel wall. The goal is to create a path through challenging lesions, where a thinner guidewire can pass but a wider catheter may not.
J&J’s new pivotal study in coronary artery disease, dubbed FORWARD CAD, will test a cardiac-focused version of the Javelin as a first-line treatment for narrowed, calcified vessels to make way for the placement of a stent. The company said its first participant has been treated at St. Francis Hospital & Heart Center in Long Island, New York.
The single-arm study plans to recruit as many as 158 patients in the U.S. and the U.K., including those with stable chest pain symptoms and those who are eligible for nonemergency cardiac procedures.
According to J&J, the peripheral-artery Javelin can deliver up to 120 pulses in a spherical energy field, while getting its tip closer to calcium deposits compared to balloon-based approaches.
The company has said that system, which was cleared by the FDA last September, has demonstrated a similar safety and effectiveness profile compared to Shockwave’s other lithotripsy catheters.