Abbott gets FDA nod to begin IVL trial after rivals buy up competition

Close-up of a detailed anatomical heart model showing the layers and structures of blood vessels.

Dive Brief:

• Abbott announced on Monday it has received approval to initiate a U.S. clinical trial for a treatment targeting severe calcification in coronary arteries.

  
  

• The intravascular lithotripsy system employs sound pressure waves to disintegrate calcium deposits obstructing blood flow. Abbott stated that the device is designed to tackle the challenges faced by existing IVL systems. 

  
  

• The IVL market has recently experienced a surge in M&A activity. Johnson & Johnson purchased Shockwave Medical last year for $13.1 billion, and Boston Scientific agreed in January to acquire Bolt Medical for up to $664 million to enter the field.

Dive Insight:

Abbott acquired Cardiovascular Systems, which was developing an IVL system, for $890 million in 2023. During an earnings call shortly after finalizing the deal, Abbott CEO Robert Ford mentioned the IVL program was a top priority as the integration team evaluated which projects would benefit from additional resources. 

Ford addressed the program again in April 2024, expressing his “excitement about entering the IVL market sometime in 2027,” but otherwise, the topic was not a focus in Abbott earnings calls. 

Abbott highlighted the program after obtaining Food and Drug Administration approval to investigate its IVL system for treating severe calcification in coronary arteries before stenting. The study will involve up to 335 participants at 47 sites in the U.S. Abbott has yet to disclose a timeline for completing the trial or discuss its endpoints.

The company is positioning IVL as a potentially better alternative to cutting balloons and atherectomy technology for removing calcified arterial blockages. By breaking calcium within the artery wall, the IVL system could facilitate vessel expansion and improved stent placement, according to Abbott. The company stated its system is designed to overcome challenges of existing IVL systems without providing specifics.

With recent market activity, J&J claims a significant lead over competitors. Tim Schmid, J&J’s worldwide chairman of medtech, stated at a TD Cowen conference earlier this month that he believes the portfolio acquired from Shockwave “has a five- to seven-year advantage over any competitors in the IVL space.”

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

Abbott’s trial initiation of its IVL system follows months after the failure of a study involving another device acquired in the CSI acquisition. The study concluded that orbital atherectomy with Abbott’s Diamondback 360 device was no more effective at treating severely calcified lesions than traditional balloon angioplasty.