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FDA Clears Abbott's Resting Full-Cycle Ratio Diagnostic Test

March 5, 2019—Abbott announced FDA clearance of the Resting Full-Cycle Ratio (RFR) diagnostic test to identify significant narrowing of arteries in patients with coronary artery disease.

DISRUPT CAD II European Postmarket Study Presented for Shockwave's Coronary IVL System

September 25, 2019—Shockwave Medical, Inc. announced that the results of the DISRUPT CAD II study were presented by coprincipal investigator Professor Carlo Di Mario, MD, in a High Impact Clinical Research session at TCT 2019, at the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 25–29 in San Francisco, California.

ILUMIEN III Compares OCT to IVUS and Angiography to Guide PCI

October 30, 2016—Results from the ILUMIEN III: OPTIMIZE PCI trial investigating adjunctive imaging modalities showed that the use of a novel optical coherence tomography (OCT)-based stent sizing strategy results in similar minimal stent area (MSA) compared to intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI).

St. Jude Medical Begins ILUMIEN III Trial of OCT Imaging

June 30, 2015—St.

SpectraWave’s HyperVue Intravascular Imaging System Cleared by FDA

March 1, 2023—SpectraWave, Inc. announced FDA 510(k) clearance of the company’s flagship HyperVue intravascular imaging system for the imaging of coronary arteries and indicated in patients who are candidates for transluminal interventional procedures.

Abbott Initiates ILUMIEN IV Trial to Assess OCT-Guided Stent Placement in High-Risk, Complex CAD Patients

April 11, 2018—Abbott Vascular announced the initiation of the ILUMIEN IV clinical trial evaluating long-term outcomes of patients undergoing stent implantation guided by optical coherence tomography (OCT) compared to angiography.

Studies Evaluate OCT and IVUS Guidance for PCI

August 27, 2023—The European Society of Cardiology (ESC) announced that findings from three studies of optical coherence tomography (OCT) for stent guidance in percutaneous coronary intervention (PCI) procedures were presented in a Hot Line session at the ESC Congress 2023 held August 25-28 in Amsterdam, the Netherlands.

Five-Year Data Presented From FAME 2 Study of Abbott's PressureWire for FFR-Guided PCI

June 4, 2018—Abbott Vascular recently announced that 5-year results from the FAME 2 study were presented in a late-breaking session at EuroPCR, held May 22–25 in Paris, France.

Neovasc’s COSIRA-II Pivotal Trial of Reducer Device Begins Enrollment

January 5, 2022—Neovasc Inc. announced enrollment of the first patient in the pivotal COSIRA-II clinical trial of the company’s coronary sinus Reducer device for the treatment of refractory angina.

Disrupt CAD Demonstrates Consistent Shockwave Coronary IVL Outcomes at 1 Year, Across Calcium Morphologies, and Between Men and Women

November 5, 2021—Data from Shockwave Medical’s Disrupt CAD clinical program demonstrating the safety and effectiveness of Shockwave coronary intravascular lithotripsy (IVL) at 1 year and consistently similar outcomes across calcium morphologies and between men and women were presented in several sessions of TCT 2021 in Orlando, Florida.

Abbott’s Ultreon OCT Imaging Software Receives FDA Clearance

August 3, 2021—Abbott announced it has received FDA clearance for an optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon imaging software.

Medtronic’s Prevail Global Pivotal Trial Begins Patient Enrollment

February 26, 2025—Medtronic announced the enrollment of the first patient in the pivotal trial of the company’s Prevail paclitaxel drug-coated balloon (DCB) catheter for in-stent restenosis (ISR) and de novo small vessel disease.