CTO Center

ORBITA-CTO Shows PCI Improves Angina in Patients With Symptomatic Single-Vessel Coronary CTO

April 1, 2026—Results from the ORBITA-CTO trial demonstrated that percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) improved angina symptoms compared with a placebo procedure in patients with single-vessel disease.

Salus Scientific AeroShield Radiation Protection Used in First Clinical Case

February 10, 2026—Salus Scientific and Tallahassee Memorial HealthCare (TMH) announced the first clinical use of AeroShield, a table-mounted, inflatable enhanced radiation protection device (ERPD), marking what the organizations described as the first deployment of the technology in a live catheterization laboratory setting.

CTO-PCI Study Begins for Simpson’s Acolyte Catheter System

August 14, 2025—Simpson Interventions, Inc. announced that its Acolyte image-guided crossing and re-entry catheter system has been used to treat the first patients in the company’s pivotal trial assessing the safety and effectiveness of percutaneous coronary intervention (PCI) with the system to treat coronary chronic total occlusions (CTOs) with persistent symptoms after medical therapy.

CTO PCI Evaluated for Long-Term Survival in Single-Center Study

May 1, 2025—The Society for Cardiovascular Angiography & Interventions (SCAI) announced findings from a study demonstrating that stenting improved long-term survival with fewer cardiac arrests at 1 year in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI).

AHA Scientific Statement Provides Expert Update on Critical Care Cardiology and CICUs

February 24, 2025—The American Heart Association (AHA) recently announced the publication of a new scientific statement that provides an update and contemporary expert perspective on the organizational structure, staffing, and care delivery in the cardiac intensive care unit (CICU) in the evolving discipline of critical care cardiology.

Simpson Interventions Shadow Catheter Cleared by FDA, Acolyte Catheter Receives IDE Approval

January 7, 2025—Simpson Interventions, Inc. announced that its Shadow catheter received FDA 510(k) clearance and its Acolyte image-guided crossing and re-entry catheter system has been granted an FDA investigational device exemption.

Multivessel TALENT Trial of SMT’s Supraflex Cruz Stent Completes Enrollment

October 3, 2024—Sahajanand Medical Technologies Pvt Ltd (SMT) announced the completion of patient enrollment in the Multivessel TALENT trial, which aims to further validate the capabilities of the company’s Supraflex Cruz stents in addressing some of the most challenging coronary conditions.

Biotronik Launches Guide Extension Catheters in Europe

September 3, 2024—Switzerland-based Biotronik announced the launch of the FlowGuide and Guidion Short guide extension catheters in selected countries that accept CE Mark.

Simpson Interventions Accepted Into FDA’s TAP Pilot Program for Breakthrough Devices

May 22, 2024—Simpson Interventions, Inc. recently announced its acceptance into the FDA Center for Devices and Radiological Health’s Total Product Life Cycle Advisory Program Pilot (TAP Pilot).

Simpson Interventions’ Acolyte System Receives FDA Breakthrough Device Designation

April 11, 2024—Simpson Interventions, Inc. announced that its Acolyte image-guided crossing and re-entry catheter system has been granted Breakthrough Device designation by the FDA.

Demax Gusta Balloons Awarded European CE Certification Under MDR

July 25, 2023—Demax Medical Technology, which is headquartered in Beijing, China, recently announced that the company’s independently developed and manufactured series of Gusta balloons for percutaneous transluminal coronary angioplasty (PTCA) received the CE Mark certificate in accordance with the European Commission’s Medical Device Regulation (MDR).

Study Examines In-Hospital and Long-Term Outcomes of CTO PCI and High-Risk Non-CTO PCI

May 16, 2023—Using the American College of Cardiology National Cardiovascular Data Registry (NCDR) CathPCI Registry to compare patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and non-CTO PCI, Almarzooq and colleagues found lower procedural success rates and higher adverse events during index hospitalization in the CTO PCI group, driven mainly by periprocedural myocardial infarction (MI) based on biomarker assessment, bleeding within 72 hours of the procedure, and intraprocedural and postprocedural cardiogenic shock.

Clinical and Procedural Outcomes of Radial Versus Femoral Access for CTO PCI Evaluated in the PROGRESS-CTO Registry

August 31, 2022—In an observational study of patients who underwent chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in the PROGRESS-CTO registry, radial-only access was used in almost one-quarter of patients, with a lower rate of access site complications and similar technical success and major adverse cardiovascular event (MACE) rates as compared with femoral access.

SCCT Expert Consensus Document Evaluates CCTA for Preprocedural Planning of Myocardial Revascularization Interventions

August 25, 2022—The Society of Cardiovascular Computed Tomography (SCCT) announced the publication of an expert consensus document that describes coronary CT angiography (CCTA) as an effective tool for interventional cardiologists to prepare and optimize coronary procedures.

PROGRESS-CTO International Registry Finds Increasing Procedural Success in CTO PCI

May 20, 2022—A new analysis was presented from PROGRESS-CTO, the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention, which is an international multicenter registry of chronic total occlusion (CTO) percutaneous coronary intervention (PCI).

Transit Scientific’s XO Cross Support Catheter Platform Receives FDA Clearance for Coronary Use

April 12, 2022—Transit Scientific announced FDA 510(k) clearance of the company’s XO Cross support catheter platform to include coronary use.

Biosensors’ Iconic Microcatheter Evaluated in BIOMICS Pivotal Trial in United Kingdom

April 5, 2022—Biosensors International Group, Ltd. announced the enrollment of the first patient in BIOMICS, a prospective, multicenter evaluation of the safety and effectiveness of the Biosensors microcatheter in patients undergoing percutaneous coronary intervention for the treatment of chronic total occlusions (CTOs).

Teleflex CTO PCI Specialty Catheters and Guidewires Receive FDA Clearance for Expanded Indication

February 23, 2022—Teleflex Incorporated announced that the FDA has cleared an expanded indication for its specialty catheters and coronary guidewires for use in crossing chronic total occlusion (CTO) during percutaneous coronary intervention (PCI).

Resolute Zotarolimus-Eluting Stents in CTOs Evaluated in 5-Year Pooled Analysis

March 19, 2021—Findings from a pooled analysis of 5-year outcomes of the Resolute zotarolimus-eluting stent (R-ZES, Medtronic) in treating coronary total occlusions (CTOs) were published by Henning Kelbæk, MD, et al in EuroIntervention (2021;16:1326-1332).

Teleflex Completes Enrollment in CTO-PCI IDE Study

February 17, 2021—Teleflex Incorporated announced the completion of patient enrollment in a clinical study evaluating the performance of Teleflex specialty catheters and coronary guidewires in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) procedures, which is currently an investigational indication for these products.