Dive Brief:

• Abbott said Monday it has received approval to start a U.S. clinical trial of a treatment for severe calcification in coronary arteries.
• The intravascular lithotripsy system uses sound pressure waves to break up calcium deposits that are blocking blood flow. Abbott said the device is designed to address the challenges of currently available IVL systems. 
• The IVL market has seen a recent rush of M&A activity. Johnson & Johnson acquired Shockwave Medical last year for $13.1 billion, and Boston Scientific agreed in January to buy Bolt Medical for up to $664 million to enter the space.

Dive Insight:

Abbott acquired Cardiovascular Systems, which had been developing an IVL system, for $890 million in 2023. On an earnings call shortly after closing the deal, Abbott CEO Robert Ford said the IVL program was high on his priority list as the integration team considered which projects would benefit from additional resources. 

Ford discussed the program again in April 2024, saying he was “excited about entry into the IVL market sometime in 2027,” but otherwise the topic fell off the list of subjects discussed on Abbott earnings calls. 

Abbott spoke up about the program after receiving Food and Drug Administration approval to study its IVL system for the treatment of severe calcification in coronary arteries prior to stenting. The study will enroll up to 335 people at 47 sites in the U.S. Abbott is yet to share a timeline for completing the trial or discuss its endpoints.

The company is pitching IVL as a potentially superior alternative to cutting balloons and atherectomy technology for clearing calcified arterial blockages. By fracturing calcium within the artery wall, the IVL system could allow for vessel expansion and better stent placement, Abbott said. The company said its system is designed to address challenges of currently available IVL systems without providing details.

With the recent activity in the market, J&J claims that it has a large head start over the competition. Tim Schmid, J&J’s worldwide chairman of medtech, said at a TD Cowen conference early this month that he believes the portfolio acquired from Shockwave “has a five- to seven-year head start on any competitors in the IVL space.”

Bolt, which Boston Scientific agreed to buy in January, completed pivotal trials of its IVL system late last year. The company planned to use the data to support filings for authorization in the U.S. and Europe. 

Abbott’s initiation of a trial of its IVL system comes months after the failure of a study of another device acquired in the CSI buyout. The study found orbital atherectomy with Abbott’s Diamondback 360 device was no better at treating severely calcified lesions than conventional balloon angioplasty.