TECTONIC CAD IVL IDE Study

Primary endpoints met

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.

Excellent Results: The TECTONIC CAD IVL IDE Study Met Primary Endpoints at 30 Days

The TECTONIC CAD IVL IDE Study achieved excellent results and met its co-primary safety and effectiveness endpoints while evaluating the investigational SonicForce™ Coronary IVL System in patients with severely calcified, stenotic de novo coronary artery lesions.1

Publication is available with open access via JACC Circulation Intervention for TECTONIC CAD: Pivotal IDE Evaluation of Coronary Intravascular Lithotripsy for Severely Calcified Lesions.

Primary Safety Endpoint1

30-day Target Lesion Failure (TLF) by Investigational SonicForce™ Coronary IVL System

0.3% Subjects (1/330) p<0.0001
Total population
0.6% Subjects (1/171)
12 mm balloon length cohort²
0.0% Subjects (0/148)
20 mm balloon length cohort²

Primary Effectiveness Endpoint1

Procedural Success by Investigational SonicForce™ Coronary IVL System

97% primary effectiveness endpoint
Primary Effectiveness endpoint chart
Stent Delivery with Final Mean Residual Stenosis <50%
99.7% (333/334)

Secondary Endpoints: As-Treated Population1


Post-IVL Stent Delivery with final mean residual stenosis <50% (Core lab assessed)
100% (333/333)
MACE
(Composite of: Cardiac death, All MI, TVR)
0.3% Subjects (1/334)
All Death
(Cardiac and Non-Cardiac)
0.3% Subjects (1/334)
All MI
(ARC-2 PPMI, 4th Universal Spontaneous)
0.3% Subjects (1/334)

OCT Evidence of Calcium Modification and Vessel Expansion with the Investigational SonicForce™ Coronary IVL System1

Pre-IVL
Pre-IVL
Post-IVL
Post-IVL
Final
Final

About the Tectonic CAD IVL IDE Study Investigating the SonicForce™ Coronary IVL System1

Study Design

The Tectonic CAD IVL IDE Study is a prospective, single-arm, open-label, multicenter, study to evaluate the safety and effectiveness of the investigational SonicForce™ Coronary IVL System to treat severely calcified, stenotic de novo coronary arteries prior to stenting and is intended to support market approval of the SonicForce™ Coronary IVL System in the United States.

335 Subjects at 40 US Sites

Intravascular imaging strongly recommended, OCT preferred

Primary Safety and Effectiveness Endpoints

Descriptive Secondary Endpoints

OCT Sub-Study

Minimum 100 subjects, of the total 335 subjects registered in the main study

Follow-up: Discharge, 30 days, 6, 12, and 24 months

Study Protocol1

  1. Placing the SonicForce™ Coronary IVL Catheter in a blood vessel with severe calcium buildup. Lesions up to 44 mm in length were included in the study. 
  2. Inflating the Balloon: The balloon (12 mm or 20 mm length) on the catheter is then inflated.
  3. Delivering Acoustic Pressure Waves: The investigational SonicForce™ Coronary IVL System sends out pulses of acoustic pressure 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.

The investigational SonicForce™ Coronary IVL System is used to prepare severely calcified coronary arteries for stenting by using acoustic pressure waves to modify calcium and improve vessel compliance.


The SonicForce™ Coronary IVL System includes:

  • SonicForce™ IVL Console: This is a reusable and portable device that powers the system.
  • SonicForce™ Coronary IVL Catheter: This is a catheter with specialty balloon for deliverying therapy in the vessel where it's needed.


Investigational SonicForce™ Coronary IVL System design

  • Available in 2 balloon lengths: 12 mm and 20 mm
  • Delivery of up to 160 pulses per catheter^
  • 2 pulses/second treatment cycle

^80 pulses per catheter tested in the IDE study

SonicForce product

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.

How Coronary Artery Calcification Affects PCI Outcomes

Coronary artery calcification is present in up to 25-30% of Percutaneous Coronary Intervention (PCI) cases and is increasingly encountered in an aging, high-risk patient population.3,4 Calcified lesions can compromise stent delivery and expansion,3,4 that can lead to:3,5

  1. Higher rates of procedural complications
  2. Stent failures
  3. Repeat revascularization
  4. Adverse clinical outcomes


As a result, effective calcium modification has become a critical component of contemporary PCI to optimize stent deployment and improve patient outcomes.4,5

IVL: Intravascular Lithotripsy
IDE: Investigational Device Exemption
MACE: Major Adverse Cardiovascular Event
TVR: Target Vessel Revascularization
PPMI: Periprocedural Myocardial Infarction
OCT: Optical Coherence Tomography

References:

  1. Secemsky EA et al. TECTONIC CAD: Pivotal IDE Evaluation of Coronary Intravascular Lithotripsy for Severely Calcified Lesions. JACC Cardiovascular Interventions. November 2026.
  2. Secemsky EA. SonicForce™ Intravascular Lithotripsy in Severe Calcific CAD: Primary Results from the TECTONIC CAD Intravascular Lithotripsy (IVL) IDE Study. Presented at TCT 2026.
  3. Riley RF, et al. J Soc Cardiovasc Angiogr Interv. 2024;3(2):101259.
  4. Sung JG, et al. Korean Circ J. 2023;53(2):55-68.
  5. Caiazzo G, et al. J Clin Med. 2023;12(14):4844.

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