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THE TAPE

GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

IDE Trial

Abbott's coronary lithotripsy trial reports 0.3 percent target lesion failure at 30 days

MedDevice Startups Staff · 4 days ago · 2 min read · Via Abbott release

Abbott's TECTONIC trial met its primary safety and effectiveness endpoints for SonicForce, an investigational coronary intravascular lithotripsy system. Target lesion failure at 30 days was 0.3 percent. Procedural success was 97 percent. Major adverse cardiac events in the as-treated population also came in at 0.3 percent.

The study enrolled 335 patients with severely calcified coronary artery disease under an FDA investigational device exemption. Abbott presented the data at TCT 2026 in San Diego on November 1 and published it the same day in JACC: Cardiovascular Interventions. SonicForce is not approved or cleared for use in the United States.

Calcium modification has turned into a crowded shelf. A 30-day safety profile this clean gets Abbott to a submission without much argument, but operators choosing between lithotripsy catheters will wait for the 12-month numbers before they switch.

Questions & Answers

What were the results of Abbott's TECTONIC trial for the SonicForce system?

Abbott's TECTONIC trial met its primary safety and effectiveness endpoints. Among 335 patients with severely calcified coronary artery disease, target lesion failure at 30 days was 0.3 percent and procedural success was 97 percent. Major adverse cardiac events were 0.3 percent in the as-treated population.

Is Abbott's SonicForce Coronary Intravascular Lithotripsy System FDA approved?

No. As of Abbott's November 1, 2026 announcement, the SonicForce Coronary Intravascular Lithotripsy System is investigational and is not approved or cleared in the United States. TECTONIC was run under an FDA investigational device exemption.

Where were Abbott's TECTONIC results presented and published?

Abbott presented the TECTONIC 30-day results at TCT 2026 in San Diego on November 1, 2026, and published them in JACC: Cardiovascular Interventions.

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