Current Surgical Navigation Challenges

Millions of vascular procedures are performed each year with minimally invasive, endovascular procedures frequently preferred over open surgical repair. To see what is happening inside the vessels, physicians rely on x-ray fluoroscopy, even though it suffers from critical limitations, including lack of soft-tissue visualization, 2D grayscale imaging, harmful radiation, and contrast dyes.

IOPS in action

The IOPSTM Difference

Introducing the Intra-Operative Positioning System (IOPS). With 3D visualization and real-time tracking at all times during a procedure, IOPS allows for surgical precision and control for accurate device placement, simplified complex procedures, and potentially decreased secondary procedures — including costly re-interventions. The system’s state-of-the-art electromagnetic tracking system currently limits, and in the future will eliminate, fluoroscopy and contrast dyes to make endovascular procedures safer for patients and physicians.

Easily integrated into existing operating room (OR) workflows, IOPS uses sensor-equipped catheters and guidewires similar to those used in current ORs to assist with clinical decision support, including accurate placement of stents and endografts.

The IOPS platform also allows for data analytics and predictive modeling to help physicians make informed decisions. These analytics and modeling are widely known to improve healthcare delivery, patient outcomes, and reduce costs.

Advanced 3D Visualization

3D visualization allows physicians to know with confidence where the surgical target is in real time.

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ADVANCED 3D VISUALIZATION

The IOPS platform uses 3D images synchronized with real-time information to enable physicians to control multiple views and look at precisely what they need to see. Currently, the patients' existing pre-operative (pre-op) CT scan is used to build the 3D models. Future iterations will not rely on pre-op imaging at all.

Controlled Navigation

The electromagnetic tracking system uses catheters and guidewires with integrated sensors that interact with IOPS to enable 360-degree GPS-like navigation.

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Controlled Navigation

With enhanced visualization and 3D GPS-like electromagnetic navigation capabilities, IOPS offers surgeons and interventionalists enhanced views of the patient-specific vascular system and the ability to perform procedures with precision and control. Separate, side-by-side high-definition views also allow physicians to triangulate the precise location for catheter or guidewire placement in real-time.

Reduced Harmful Radiation

IOPS does not rely on fluoroscopy, helping decrease overall exposure to cancer-causing ionizing radiation effects for healthcare staff and patients.

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REDUCED HARMFUL RADIATION

X-ray fluoroscopy for minimally invasive surgeries, including endovascular procedures, expose physicians, staff, and patients to dangerous levels of ionizing radiation that increases the risk for harmful effects and with repeat exposure, cancer. IOPS does not use fluoroscopy and decreases radiation and contrast dyes by using a low-intensity electromagnetic tracking system.

Physician exposure varies widely depending upon the procedure performed. Several studies have assessed operator exposure during different fluoroscopy-guided endovascular procedures and found:

• Endovascular Aortic Repair (EVAR) for aortic aneurysms and Transcatheter Aortic Valve Replacement (TAVR) have two of the highest radiation exposures rates faced by vascular physicians despite protective gear
• Ocular (eye) exposure has been studied for EVAR, TAVR, and other peripheral interventions due to the risk of radiation-related cataract formation
• Nurses and technologists are also exposed to radiation during vascular procedures1


Substantial amounts of radiation exposure in patients during endovascular surgery have been repeatedly measured and reported as well, with aortic procedures incurring the highest patient exposure rates.1



Reference: 1. Physician and Patient Radiation Exposure During Endovascular Procedures. Goldsweig, A.M., Abbott, J.D. & Aronow, H.D. Curr Treat Options Cardio Med (2017) 19: 10. https://doi.org/10.1007/s11936-017-0507-9.

Less Procedure Time

Complex endovascular procedures can be simplified through improved visualization and navigation.

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LESS PROCEDURE TIME

Enhanced visualization and navigation capabilities, simplifies complex procedures, improves device placement accuracy, and lowers the risk for errors and additional follow-up procedures, offering the potential for significant time savings.

Lower Healthcare Costs

Reduces procedural time and lowers the risk for errors which could reduce costly follow-up procedures.

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LOWER HEALTHCARE COSTS

By making vascular imaging procedures more efficient, IOPS allows healthcare providers to save time and increase the utilization of the operating room or catheterization lab, allowing hospitals to perform procedures with higher profit margins. Simplified complex procedures and increased device placement accuracy has the potential to lower the risk of errors and minimize costly secondary procedures.

Broad Clinical Applications

Targets a broad spectrum of endovascular procedures and offers an extensible platform for growth.

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BROAD CLINICAL APPLICATIONS

With its enhanced visualization and navigation capabilities, IOPS helps simplify a variety of complex aortic repair procedures. In the future, the system will also address other diseases.

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In addition to offering value across a broad spectrum of endovascular procedures, the IOPS platform is also under development for use in non-vascular markets, including bronchoscopy and electrophysiology.


*IOPS is not currently indicated for this procedure.

IOPS TECHNOLOGY

Our Technology at Work

Designed for surgical precision and control, simplified procedures and reduced radiation exposure for patients and healthcare professionals, IOPS easily integrates into existing OR and lab workflows. Shown below is the workflow for the IOPS initial application: aortic repair.

WORKFLOW EXAMPLE

STEP 1

Generate Model Based on Pre-op CT Scan

generate model based on pre-op CT scan

Model is created by using data that has already been collected and can be done in minutes, anytime between the pre-op CT and patient registration.

generate model based on pre-op CT scan

STEP 2

System Setup

generate model based on pre-op CT scan

Wheel cart into the OR and attach the tracking system onto the operating table. The tracking system easily fastens to the table without any tools and can even be secured and removed while the patient is on the table, if necessary.

generate model based on pre-op CT scan

STEP 3

Tracking and Registration

attach the tracking pad to the patient

Attach the tracking pad to the patient and perform registration. The registration to merge or fuse mimics the existing process used for fluoroscopy overlay.

generate model based on pre-op CT scan

STEP 4

Perform the Procedure

perform the procedure

Use advanced 3D visualization and real-time tracking to assist in the procedure. All wires and catheters used are similar to those used in current workflows and are visible under fluoroscopy.

generate model based on pre-op CT scan

IOPS EXPLAINED

Frequently Asked Questions (FAQs)

What type of image does IOPS present to the physician and why?

IOPS provides a 3D rendering in full color to create an imaging experience that is instantly intuitive. Due to its clarity and color in high-definition, the image allows the viewer to immediately understand what he/she is looking at, without the need for interpretation. Additionally, IOPS offers an industry-standard four-viewport, multiplaner display of a patient’s anatomy and all surgical instruments being used. Since doctors and technologists are accustomed to this type of display, the visualization and controls are familiar and straightforward.

What is IOPS?

The Intra-Operative Positioning System (IOPS) is an innovative system used to navigate catheters and guidewires in the 3D anatomy of patients, allowing physicians to perform effective, cost-effective, radiation-free endovascular procedures with precision and control to help reduce errors and costly follow-up procedures.

What is intravascular ultrasound and how does it differ from IOPS?

Intravascular ultrasound (IVUS) is a medical imaging modality that uses a catheter with a miniaturized ultrasound probe attached to the end. The catheter is attached to computerized ultrasound equipment. It allows the surgeon to see from inside blood vessels out to the inner wall of blood vessels.

Despite success in certain vascular procedures, IVUS images are grainy and only allow physicians to see a cross-section of the vessel. These limitations can lead to increased procedural times or increased costs.

IOPS color-rendered images in multiple views provide physicians with clearer visualization and can be used in more areas of the human vascular system.

What is fluoroscopic overlay and how does it differ from IOPS?

Fluoroscopic overlay is an imaging technique that uses pre-acquired scans (such as a CT scan) in combination with fluoroscopy, in order to reduce some of the challenges associated with fluoroscopic navigation alone. Images of the scans are overlaid on top of the fluoroscopic x-ray image and registered (aligned) using initial imaging. Thus, even when not actively firing x-rays, the anatomy is seen on screen. In order to see catheters, guidewires, or other tools, surgeons must still use radiation. The registration is fixed; if the patient moves, the registration must be re-performed.

IOPS differs as it is not dependent on fluoroscopy to deliver an image to the physician during the case, and provides visualization of both the native anatomy and the surgical tools. This sets IOPS apart to not only further reduce the exposure of radiation and usage of contrast dye (only to patients) but also to deliver a much superior image.

How does IOPS maintain image registration?

Image registration with IOPS currently begins with registering the intraoperative CBCT with the preoperative MDCT. Once that is done, the tracking pad on the patient’s back is used to detect patient motion and correct the registration for any deviations during the procedure. The tracking pad will not adjust for automatic movement, such as peristalsis, breathing, or heartbeat. Catheter, guidewire, and tracking pad sensors data sampling is performed dozens of times a second, minimizing the latency of rendering updates.

What types of imaging systems work with IOPS?

IOPS can be used with computed tomography angiography (CTA). The capability to use magnetic resonance angiography (MRA) is under development.

Is it difficult to adopt and deploy IOPS?

No; IOPS fits seamlessly into the existing operative workflow. IOPS was designed to be quickly rolled into an OR and be ready within minutes. The cart contains a powerful computer and graphics system that allows the vascular system to be rendered, displayed, and followed by the physician. The electromagnetic field generator is lightweight and can be attached to any surgical table within minutes. When not in use, it stows safely on the cart. The consumables have been designed to be identical in form and function to existing tools used by physicians today.

What other technical applications might IOPS be used for?

Centerline Biomedical is rapidly developing future IOPS products for non-aortic endovascular interventions as well as other minimally invasive procedures to further the goal of protecting healthcare staff while improving patient quality of life by increasing the efficacy and availability of the least traumatic care possible.

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