Abbott reports strong 30‑day safety and efficacy results for investigational SonicForce IVL system
Abbott announced that its investigational SonicForce Coronary Intravascular Lithotripsy (IVL) system met both primary safety and effectiveness endpoints in the TECTONIC study. The IDE trial enrolled 335 patients with severe coronary calcification at 40 U.S. sites and showed a 0.3% 30‑day target lesion failure rate and 97% procedural success. Optical coherence tomography in a 106‑patient imaging sub‑study confirmed calcium fractures after treatment. Abbott said approval would broaden its coronary device portfolio.
Why it matters
The low failure rate and high procedural success suggest the SonicForce system could become a valuable tool for treating heavily calcified lesions, potentially increasing Abbott's market share in coronary interventional devices. If the FDA grants approval, Abbott would add a novel IVL therapy to its product line, expanding revenue opportunities in cardiovascular care.
Key facts
- 1The TECTONIC study enrolled 335 patients with severely calcified coronary artery disease across 40 U.S. sites. prnewswire.com
- 2The 30‑day target lesion failure rate was 0.3% in the as‑treated population. prnewswire.com
- 3Procedural success was achieved in 97% of patients. prnewswire.com
- 4In a prespecified imaging sub‑study of 106 patients, OCT identified calcium fractures after treatment. prnewswire.com
- 5The investigational SonicForce system has not yet received FDA approval and is limited to investigational use. prnewswire.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.