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TECTONIC CAD IVL IDE Study

Patient enrollment is complete for the TECTONIC clinical trial. A special thanks to the investigators, research coordinators and enrolled patients for making this trial possible.

TECTONIC CAD IVL IDE Study

About the TECTONIC CAD IVL IDE Study

Abbott is testing a new treatment for people with coronary artery disease. This disease causes the arteries in your heart to narrow due to hard calcium buildup. Before placing a stent (a small tube to keep the artery open), Abbott wants to see if their new treatment can help.

The new treatment investigates Abbott's new SonicForce™ Coronary Intravascular Lithotripsy (IVL) System, a special device to prepare the blood vessels in your heart. The device works by using a balloon to widen the sections of the arteries that are narrowed by calcium. The purpose of this study is to check if the investigational SonicForce™ Coronary IVL System is safe and effective. The system is designed to treat arteries that are severely blocked by calcium before placing a stent.

What is the Study Device?

The device being tested is called the SonicForce™ Coronary IVL System. This system uses a special technique called intravascular lithotripsy to break up hard calcium in your arteries and prepare them for placing a stent.

SonicForce device

What Does the Investigational SonicForce™ Coronary IVL System Include?

  • Console: This is a reusable machine that controls and powers the system. It helps break up the hard calcium buildup in your blood vessels.
  • IVL Catheter: This is a thin, flexible tube that delivers the treatment to the exact spot in your blood vessel where it's needed.

How Does It Work?

The investigational SonicForce™ Coronary IVL System uses sound waves to break up the hard calcium buildup in your blood vessels. This makes it easier for your doctor to treat the blood vessel and place a stent more effectively.

Effect of the Treatment

When the investigational SonicForce™ Coronary IVL System is powered up, it creates sound waves called lithotripsy. These sound waves travel to the treatment area in your coronary artery and break up the hard calcium buildup in your blood vessel. This helps prepare the artery for placing a stent.

Summary of the Treatment Procedure

  1. Placing the Catheter: A thin, flexible tube called the IVL catheter is placed in the area of your blood vessel that has hard calcium buildup.
  2. Inflating the Balloon: The balloon on the catheter is then inflated.
  3. Delivering Sound Waves: The investigational SonicForce™ Coronary IVL system sends out pulses of sound waves to break up the calcium in the targeted area.
  4. Placing the Stent: Once the calcium is broken up and the blood vessel is prepared, a stent is placed in the treated area to keep the artery open.

CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only. Outside the U.S., the device is subject to local regulatory requirements and is not commercially available.

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