Abbott Laboratories (ABT) said Monday that its Coronary Intravascular Lithotripsy System has received an investigational device exemption from the US Food and Drug Administration.
The company said its intravascular lithotripsy clinical trial, which aims to improve outcomes in coronary artery disease patients, will enroll up to 335 people in 47 locations in the US.
The investigational device aims to treat arterial calcium blockages by using high-energy sound pressure waves, the company said.
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