ABT · News · 20261103N
IVL Market and Product Launch
ABBOTT LABORATORIES · 2026-11-03 · Importance 34 · Surprise 42 · In source text
Abbott reported that its investigational SonicForce coronary intravascular lithotripsy (IVL) system met the primary safety and effectiveness endpoints in the TECTONIC CAD IVL IDE study. The 30-day results showed low target lesion failure and high procedural success and were presented at TCT 2026 and published in JACC: Cardiovascular Interventions. Abbott anticipates FDA approval in the first half of 2027, which would advance the system toward a U.S. launch in the coronary IVL market.
Key facts
- Abbott anticipates FDA approval for SonicForce IVL in the first half of 2027. source
- Abbott announced at TCT 2026 that its investigational SonicForce coronary intravascular lithotripsy (IVL) system met the primary safety and effectiveness endpoints in the TECTONIC CAD IVL IDE study. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | Abbott anticipates FDA approval for SonicForce IVL in the first half of 2027. |