Efficacy of a new generation intracoronary optical coherence tomography imaging system with fast pullback

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Objectives We sought to investigate whether a novel, fast-pullback, high-frequency optical coherence tomography (HF-OCT) imaging system enables data acquisition with a reduced amount of contrast agents while retaining the same qualitative and quantitative lesion assessment to conventional OCT. Background The increased amount of administered contrast agents is a major concern when performing intracoronary OCT. Methods The present study is a single-center, prospective, observational study including 10 patients with stable coronary artery disease. A total of 28 individual coronary arteries were assessed by both fast-pullback HF-OCT and by conventional OCT. Results The contrast volume used in each OCT run for the HF-OCT system was significantly lower than for the conventional OCT system (5.0 ± 0.0 mL vs. 7.8 ± 0.7 mL, respectively, with a mean difference of −2.84 [95% confidence interval [CI]: −3.10 to −2.58]). No significant difference was found in the median value of the clear ...

World’s First Intracranial Use of a New High-Frequency Imaging System to Directly Visualize Neurovascular Pathologies

First human procedures performed by Prof Vitor Mendes Pereira at St. Michael’s Hospital, a site of Unity Health Toronto Gentuity, LLC, an advanced imaging technology firm, today announced the first human use of the Vis-MTM High-Frequency Optical Coherence Tomography (HF-OCT) imaging system and probe. This represents a significant technological advance for the field of neurointervention, making high resolution intravascular imaging in the brain possible. “This is an incredibly exciting milestone. The direct visualization technology we evaluated here offers unprecedented potential in the diagnosis and treatment of aneurysms, stroke, intra-cranial atherosclerotic disease (ICAD) and other neurological pathologies,” said Vitor Mendes Pereira, MD. “I am proud and honored to have the opportunity to perform the first cases. The system and imaging probes performed very well, integrating with our workflow seamlessly, and provided us with important information that we cannot obtain with any ...

Morton Kern, MD @TCT: What’s New in OCT and the Langston Returns

Dr. Morton Kern shares his reaction to the Gentuity High Frequency (HF)-optical coherence tomography (OCT) catheter, the return of the Langston catheter (Teleflex), and interventionalist multi-stage careers. ( Read Full Article )

Total Vessel Imaging With the Gentuity High-Frequency Optical Coherence Tomography System

I was an early adopter of optical coherence tomography (OCT). I participated in the development of the very first generation when OCT came to the United States and was involved with the image analysis efforts that were part of the first FDA approval. It has been a long journey with intravascular OCT in not only the research side, but also in the clinical arena. OCT has now been part of my day-to-day practice for more than a decade. My go-to intravascular imaging is OCT, with a small percentage of intravascular ultrasound (IVUS) use. I am currently working with the next-generation device, High-Frequency OCT (HF-OCT) (Gentuity). I had the privilege of doing the first-in-human case here at Tampa General Hospital and continue to enroll cases as we build on the first clinical experience. We are also enrolling patients in a second trial that involves side-by-side use of HF-OCT and pressure measurements. ( Read Full Article )

High-frequency optical coherence tomography predictors of aneurysm occlusion following flow diverter treatment in a preclinical model

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Background: High-frequency optical coherence tomography (HF-OCT) is an intravascular imaging method that allows for volumetric imaging of flow diverters in vivo. Objective: To examine the hypothesis that a threshold for both volume and area of communicating malapposition can be predictive of early aneurysm occlusion. Methods: Fifty-two rabbits underwent elastase aneurysm formation, followed by treatment with a flow diverter. At the time of implant, HF-OCT was acquired to study the rate and degree of communicating malapposition. Treated aneurysms were allowed to heal for either 90 or 180 days and euthanized following catheter angiography. Healing was dichotomized into aneurysm remnant or neck remnant/complete occlusion. Communicating malapposition was measured by HF-OCT using a semi-automatic algorithm able to detect any points where the flow diverter was more than 50 µm from the vessel wall. This was then summed across image slices to either a volume or area. Finally, a subsam...

Desmond Adler Becomes President of Cardiovascular at Gentuity LLC

Desmond Adler becomes President of Cardiovascular at Gentiuity, LLC. Dr. Adler is a Biomedical executive, team builder, and strategic innovator with a 20-year track record of commercial success in highly competitive markets. Developed and launched multiple disruptive products in ophthalmology, cardiology, and gastroenterology including drug-device combination therapies and imaging systems. Key contributor to two acquisitions ($90M and $497M) and one IPO ($245M) in the last 10 years.  He left is position of General Manager and VP of R&D, Corneal Health, at Glaukos Corporation.

Transvascular in vivo microscopy of the subarachnoid space

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Background The micro-architectonics of the subarachnoid space (SAS) remain partially understood and largely ignored, likely the result of the inability to image these structures in vivo. We explored transvascular imaging with high-frequency optical coherence tomography (HF-OCT) to interrogate the SAS. Methods In vivo HF-OCT was performed in 10 dogs in both the posterior and anterior cerebral circulations. The conduit vessels used were the basilar, anterior spinal, and middle and anterior cerebral arteries through which the perivascular SAS was imaged. The HF-OCT imaging probe was introduced via a microcatheter and images were acquired using a contrast injection (3.5 mL/s) for blood clearance. Segmentation and three-dimensional rendering of HF-OCT images were performed to study the different configurations and porosity of the subarachnoid trabeculae (SAT) as a function of location. Results Of 13 acquisitions, three were excluded due to suboptimal image quality. Analysis of 15 locatio...

Welcoming Gentuity® to the Nipro Vascular Portfolio

Nipro Medical Corporation is proud to announce a commercial partnership in the United States with Gentuity LLC . Gentuity, an imaging technology firm founded in Massachusetts in 2015, is dedicated to developing next-generation intravascular devices that capitalize on today’s best-in-class technologies. With a proprietary platform fully incorporating the company’s AI tools to enhance ease of use and procedural success, Gentuity is transforming the world of intravascular imaging. Together with Gentuity, Nipro is excited to continue advancing patient care, improving outcomes, and delivering more value to healthcare providers. EXPERIENCE THE NEXT GENERATION OF OCT Nipro is excited to now offer the following Gentuity products: High-Frequency OCT Imaging System : An innovative and ergonomic console powered by machine learning technology, this system offers excellent planning insights with One Second Imaging™ – the fastest and longest pullback available in the U.S. Vis-Rx® Micro-Imaging Ca...

Optical Coherence Tomography for Neurovascular Disorders

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Diagnosis of cerebrovascular disease includes vascular neuroimaging techniques such as CT angiography, MR angiography (with or without use of contrast agents) and catheter digital subtraction angiography. These techniques provide mostly information about the vessel lumen. Vessel wall imaging with MR seeks to characterize cerebrovascular pathology, but with resolution that is often insufficient for small lesions. Intravascular imaging techniques such as ultrasound and optical coherence tomography (OCT), used for over a decade in the peripheral circulation, is not amendable to routine deployment in the intracranial circulation due to vessel caliber and tortuosity. However, advances in OCT technology including the probe profile, stiffness and unique distal rotation solution, holds the promise for eventual translation of OCT into the clinical arena. As such, it is apropos to review this technology and present the rationale for utilization of OCT in the cerebrovasculature. ( Read Ful...

‘World-first’ treatment of patient with high-frequency OCT for cardiology intervention

A partnership of Tampa General Hospital (TGH) and University of South Florida’s Health Interventional Cardiology Group have adopted a new intravascular imaging technology and performed the first such procedure in the world. The new intravascular technology, called High Frequency Optical Coherence Tomography (HF-OCT), was recently performed on a patient with critical coronary artery disease, which the partners say, “was the first such successfully treated in the world.” Tampa General has been an early adopter of intravascular imaging for coronary intervention and continues to seek the newest and best technology. The team has incorporated intravascular ultrasound (IVUS) and intravascular optical coherence tomography to look inside the blood vessels. The hospital is now using the FDA-cleared Gentuity HF-OCT Imaging System with the Vis-Rx Micro-Imaging Catheter to treat patients who are candidates for certain interventional procedures. The system utilizes fiber-optic t...

Tampa General Hospital/USF Health Interventional Cardiology Team Adopts New Intravascular Imaging Technology and Performs First Case in the World

Tampa General Hospital and USF Health's Interventional Cardiology team has adopted new intravascular technology and successfully treated the first patient in the world. Tampa General has built a legacy as an early adopter of intravascular imaging for coronary intervention and continues to seek the newest and best technology. The team has incorporated intravascular ultrasound (IVUS) and intravascular optical coherence tomography through the years to look inside the blood vessels. ( Read Full Article )

High-resolution image-guided WEB aneurysm embolization by high-frequency optical coherence tomography

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Background High-frequency optical coherence tomography (HF-OCT) is an intra-vascular imaging technique capable of assessing device-vessel interactions at spatial resolution approaching 10 µm. We tested the hypothesis that adequately deployed Woven EndoBridge (WEB) devices as visualized by HF-OCT lead to higher aneurysm occlusion rates. Methods In a leporine model, elastase-induced aneurysms (n=24) were treated with the WEB device. HF-OCT and digital subtraction angiography (DSA) were performed following WEB deployment and repeated at 4, 8, and 12 weeks. Protrusion (0-present, 1-absent) and malapposition (0-malapposed, 1-neck apposition >50%) were binary coded. A device was considered ‘adequately deployed’ by HF-OCT and DSA if apposed and non-protruding. Aneurysm healing on DSA was reported using the 4-point WEB occlusion score: A or B grades were considered positive outcome. Neointimal coverage was quantified on HF-OCT images at 12 weeks and compared with...

Acute Thrombus Burden on Coated Flow Diverters Assessed by High Frequency Optical Coherence Tomography

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Purpose The implantation of flow diverters requires administration of dual anti-platelet therapy, posing the potential for complications. The p48MW HPC (phenox, Bochüm, Germany) hydrophilic-coated flow diverting stent is designed to be anti-thrombotic, thus opening the potential for single anti-platelet therapy. We deploy a novel intravascular high-resolution imaging technique, high-frequency optical coherence tomography (HF-OCT), to study in an animal model the acute thrombus formation on coated p48MW devices versus uncoated control devices. Methods Three pigs were implanted with 4 flow diverters each, two test hydrophilic-coated devices, and two control uncoated devices (p48MW). Each pig was treated with a different anti-platelet regime: no anti-platelet therapy, aspirin only, aspirin and clopidogrel. Twenty minutes after the flow diverter was implanted, an HF-OCT data set was acquired. Acute clot formed on the flow diverter at each covered side branch was measured from the H...

Gentuity FDA 510k HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at identifies combination product submissions. The general controls provisions of the...

Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter

Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures. ( Read Full Article )


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