Dive Brief:
- Johnson & Johnson said Monday it has enrolled the first patient in a pivotal study of a device for clearing “difficult-to-cross” coronary arteries.
- Like other products made by J&J’s Shockwave Medical, the Javelin intravascular lithotripsy catheter uses sound pressure waves to break up calcium deposits that are blocking blood flow.
- The device is differentiated from other Shockwave products, and rival catheters from Abbott and Boston Scientific, because it emits waves from its tip. Other devices send waves from a balloon catheter that must cross the blocked part of the artery to be effective.
Dive Insight:
Shockwave revealed the Javelin device at an investor event in October 2023, months before accepting a $13.1 billion buyout bid from J&J. The company developed Javelin after recognizing that balloon-based catheters are unable to pass through some vessels. If physicians cannot get a balloon across a vessel, they cannot use Shockwave’s other IVL devices to remove calcium deposits.
By miniaturizing its IVL technology, Shockwave developed a catheter capable of emitting waves from its tip. Rather than crossing the artery and then emitting waves from the balloon, the device sends out IVL pulses from the tip to clear deposits and allow the catheter to advance along the vessel.
The Food and Drug Administration cleared a Javelin device for use in peripheral vessels last year, opening up more of the below-the-knee market. The new study will enroll up to 158 patients across around 35 sites in the U.S. and U.K. to generate data to unlock more of the coronary market.
J&J’s investment in Javelin technology could provide a point of difference versus companies that are mounting challenges for the IVL market. Boston Scientific recently entered the space by agreeing to pay $443 million upfront for Bolt Medical. Abbott acquired an IVL program in 2023 as part of its $890 million takeover of Cardiovascular Systems and received approval to start a trial in the U.S. last month.
Abbott’s device uses a balloon to widen parts of the arteries that are narrowed by calcium. Similarly, Bolt was working on a balloon catheter when it accepted Boston Scientific’s offer. The use of balloons makes the investigational devices potential competitors to J&J products such as Shockwave C2.
With Javelin, J&J is staking out new territory in the IVL market by eliminating the balloon from the design. The market for balloon-free devices may be relatively small. Shockwave said Javelin was designed to address 5% of the market, at most, when it unveiled the device in 2023.
