Introducing the Latest FFRangio System – Video Highlight from Dr. Rahul Sharma’s CVIT Webinar

Introducing the Latest FFRangio System – Video Highlight from Dr. Rahul Sharma’s CVIT Webinar

The latest CathWorks FFRangio System delivers wire-free and drug-free 3D FFR guidance that is practical for every case.

In this video highlight from CVIT Japan 2021, Dr. Rahul P. Sharma, MBBS, FRACP, Director of Structural Interventions at Stanford Medical Center, gives a “live” view of the software interface and details the essential information depicted on screen, including:

  • Accurate multi-vessel FFR
  • 3D model of the coronary tree
  • FFRangio | IMPACT – characterizing overall disease burden
  • Angiograms overlaid with 3D QCA and FFR
  • Sizing tool and 3D QCA – aids in procedural planning

Watch Dr. Sharma’s full CVIT webinar here

How Does FFRangio Work? – Insights from Dr. Rahul Sharma’s CVIT 2021 Presentation

FFRangio is a non-invasive, angiography-based system that provides quick, wire-free, and drug-free assessment of FFR for multiple vessels.

In this video highlight from CVIT Japan 2021, Dr. Rahul P. Sharma, MBBS, FRACP, Director of Structural Interventions at Stanford Medical Center, gives an overview of how FFRangio works.

Topics include:

  • 3D model reconstruction – including 3D QCA from routine angiograms without an invasive wire
  • Resistance analysis and FFR – from resistance mapping and computational FFR modeling
  • 3D physiology – with superimposed, color-coded FFR values in multiple vessels
  • FFRangio system results – highlighting the software interface and the important information depicted on screen at the end of analysis

Watch Dr. Sharma’s full CVIT webinar here

FFRangio in Clinical Practice – CVIT Webinar + Q&A with Dr. Rahul P. Sharma

In this virtual webinar presentation from CVIT Japan 2021, Dr. Rahul P. Sharma, MBBS, FRACP, Director of Structural Interventions at Stanford Medical Center, shares his experience with the latest FFRangio software and discusses important benefits of FFRangio for routine clinical practice.

At the end of the video, there is a question-and-answer session with renowned cardiologists Dr. Hitoshi Matsuo of Gifu Heart Center and Dr. Hiroyoshi Yokoi of Fukuoka Sanno Hospital.

Video topics include:

  • Why do we need image-based FFR?
  • How does FFRangio work?
  • An overview of the latest FFRangio system
  • FFRangio clinical integration, including use at Stanford Medical Center
  • LAD lesion case study
  • Panel question-and-answer session

FFRangio in Clinical Practice – An Interview with Dr. Antreas Hindoyan

An Interview with Antreas Hindoyan, MD Dr. Hindoyan, interventional cardiologist at Keck Hospital of USC, discusses the future of coronary physiology and how the CathWorks FFRangio™ System can provide value for PCI decision-making.

How have you integrated wire-based FFR into clinical practice at Keck Hospital of USC? Why is it important for your practice?

I’ve been using FFR since I was a cardiology fellow, and it has become an integral part of our standard PCI procedure workflow at Keck USC. FFR is now a part of the vernacular among the staff. Whenever we have a questionable lesion, it’s not only the doctor suggesting a physiology assessment—the techs and staff are also vocal about using FFR.

The whole goal of treatment is to make the patient feel better and improve outcomes. For patients with stable CAD and an intermediate lesion, it can be unclear which treatment is best for them. That is where an objective measurement will be most useful. If you have a lesion that is not hemodynamically significant, the data shows that a stent will not provide any extra benefit compared to medical therapy. So FFR really standardized our process of deciding which CAD patients should get a stent and which should not.

Are you seeing more hospitals adopting FFR over time?

Yes. Over the last 10 years FFR utilization has increased steadily, and it’s starting to become standard of care in most hospitals. FFR is very easy to conceptualize and provides a clear benefit, and that’s part of the reason why more physicians are adopting it.

I think we’ll see more growth and adoption going forward. It will continue to be important for physicians to have clear documentation of hemodynamic significance prior to stenting, especially for patients with intermediate lesions. Even if the patient arrives at the Cath lab with a stress test or a nuclear test, there is no substitute for a significant FFR value to determine if the patient needs a stent.

Data continues to support broader use of FFR to guide PCI decision-making, but it’s still underutilized compared to clinical guideline recommendations. What needs to happen to make FFR standard of care for more patients?

Procedure time is a big factor. In the Cath lab, the most important commodity is time. The longer you stay in the Cath lab, the greater the risk of complications, patient discomfort, and other issues. You want to be as efficient as possible.

For pressure wire FFR, you need to consider how Adenosine might affect the patient. Hyperemia causes drops in blood pressure and patients feel flushed, which they don’t like. And if you have a patient with a tenuous blood pressure, you might have some issues.

There’s also a risk of complications, especially with oldergeneration pressure wires that are more difficult to handle compared to standard workhorse wires. It would be horrible to cause a dissection in the vessel during a simple diagnostic test. And if a patient has thrombocytopenia, high INR, or cirrhosis with a low platelet count, you want to avoid heparin and placing a wire unless you really need to.

I think all these factors give pause to the interventionalist, which explains the underutilization we’re seeing. Any new FFR technology that addresses some or all these limitations would be very welcomed in the Cath lab.

You’ve been using the wire-free and drug-free CathWorks FFRangio™ System for about a year now. What was your initial experience like?

As an interventionist, you are generally skeptical of new technology, so we wanted to validate the technology ourselves. Early on, we had a patient with a mild/intermediate lesion that I would have guessed did not need a stent. We decided to run an FFRangio analysis and the results showed FFR was significant at 0.72, which was surprising. So, we ran a wire-based FFR just to be sure and got a very similar result. Clearly, there was correlation between the two technologies, and they both told me something different than what I predicted based on the angiogram. We ended up stenting and the patient did great with a lot of symptom improvement. That was a galvanizing experience for us and the moment we knew the technology worked. And we had several similar cases after that, which gave us a lot of confidence. Once we adopted the technology, we started using it in patients we would not normally use wire-based FFR in. Since it doesn’t require heparin or Adenosine, we can actually apply it to more patients.

What do you think are the main benefits of FFRangio compared to traditional wire-based FFR?

FFRangio has added both benefit and safety to the Cath lab. Getting rid of Adenosine is important, especially for patients with a tenuous blood pressure. But we’ve seen a greater benefit in getting rid of heparin. For some patients, we’re hesitant to use a pressure wire because of the risk of complications and bleeding from anticoagulation. Now we can evaluate these patients with FFRangio and still get an accurate FFR measurement. If the patient has a normal FFR, it’s nice that you can send the patient home with just a diagnostic angiogram, and you would have avoided heparin and Adenosine.

The ability to get results quickly in multiple vessels is another advantage of FFRangio. Sometimes you have multiple lesions, and you need a treatment strategy for each one. With the wire, you would have to do multiple measurements, and you need to be sure the Adenosine has completely left the system before the second injection. With FFRangio, you don’t have to worry about that because the analysis is based on angiogram images.

What has the process been like to integrate FFRangio into practice at Keck USC? Any advice for other physicians considering the technology?

In our lab, our CV techs and nurses run the FFRangio analysis. They get the analysis started while I take some additional images. I assist with selecting angiograms and identifying vessels/lesions, but our staff usually drives the process. Our CathWorks rep was great in helping us get comfortable with the technology and get past the initial learning curve. Speed, accuracy, and ease of use are the most important factors. I’ve now seen a couple product iterations and with every update, it’s become more efficient, faster, and more user friendly. I think FFRangio has been easy to use for our team.

I am very happy I had the opportunity to be one of the early adopters of FFRangio. I’m a firm believer in the technology and think of it as my first-line tool for physiology guidance. My advice to other physicians is to try it. Once you have the proper training, it makes your Cath lab more efficient and safer and takes the guesswork out of some complex patients where the wire may not be the optimal choice.

Now that non-invasive technologies like FFRangio are available, what do you think is the future of physiologybased PCI guidance?

I think use of physiology guidance will continue to increase over time. The patient benefit is clear, and you always want an objective justification for the stenting decision. One area I think we’ll see some growth is evaluating FFR after PCI. There’s value there, but the concept has not yet caught on because interventionalists are hesitant to place another wire and risk a potential complication unless they have to. With a non-invasive technology, you might be more inclined to check FFR after stenting and provide additional treatment if the resulting FFR value is still low.*

Another interesting application: in some hospitals, you may also start to see non-interventional cardiologists adding an FFRangio analysis to their diagnostic angiograms. Since it doesn’t require an additional intervention, it creates an opportunity to assess FFR for cardiologists who wouldn’t normally do a wire-based procedure. I can absolutely see quick, non-invasive FFR technologies like FFRangio replacing wire-based methods and becoming the first option for physiology guidance. Ultimately, by expanding the patients who can get FFR, it should improve outcomes and satisfaction for more patients.

*Diagnostic performance of FFRangio compared to FFR wires has not been established for lesions immediately after PCI.

CathWorks Announces $30 Million in New Financing

CathWorks reported the completion of a $30 million Series D financing round. Proceeds from the financing will be used to expand commercialization of the company’s FFRangio system.

Jim Corbett, CathWorks CEO stated, “We are delighted to have received this round of funding, which included both new and existing investors. Our initial market launch demonstrated there is tremendous excitement around the clinical value of the CathWorks FFRangio™ System. This funding paves the way for continued commercialization and expanded access to the technology for physicians, hospitals and patients.”

The CathWorks FFRangio System is a non-invasive diagnostic technology that is used at the time of a routine angiography. The CathWorks FFRangio System transforms routine angiogram images into objective and comprehensive physiology information, including color-coded 3D renderings of blood flow in the heart’s arteries to help physicians optimize coronary artery disease decision making, including whether a stent is needed.

“The non-invasive FFRangio system has the potential to become standard of care, providing significant clinical and economic value,” Mr. Corbett added.  “We are very excited for this investment supporting FFRangio market expansion.”

About CathWorks

CathWorks is a medical technology company focused on applying its advanced computational science platform to optimize Coronary Artery Disease (CAD) therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians. FFR-guided PCI decision-making is proven to provide significant clinical benefits for patients with coronary artery disease and economic benefits for patients and payers. The company’s focus today is specifically on bringing the CathWorks FFRangio™ System to market to provide quick, precise, and objective intraprocedural wire-free FFR guidance that is practical for every case. For more information, visit www.cath.works.

FFRangio Pooled Analysis from 5 Prospective Cohort Studies

Excellent diagnostic performance: 91% sensitivity, 94% specificity, and 93% diagnostic accuracy

This lesion-level pooled data analysis of 588 patients and 700 lesions represents the “largest and most diverse cohort of any single angiogram-based FFR technology reported.” Results indicate FFRangio has excellent diagnostic performance, strong correlation, and that results were robust across a wide spectrum of patients and lesion characteristics.

FAME II Trial

PCI in patients with FFR ≤ 0.80 reduced clinical events by 66% compared to medical therapy alone at 1 year.

The FAME II Trial randomized stable CAD patients with FFR ≤ 0.80 to PCI + medical therapy or medical therapy alone. Enrollment was halted early after 1,220 patients because of a significant between-group difference in the events, driven by a lower rate of urgent revascularization in the PCI group than in the medical therapy group. Continue reading “FAME II Trial”

FAME Trial Economic Analysis

14% reduction in overall costs at 1 year.

Economic analysis of the FAME Trial revealed that PCI guided by FFR saves costs and improves health outcomes at 1 year compared with angiography guidance. Cost savings are driven by a decrease in stent use during the initial procedure, a decrease in rehospitalization and fewer major adverse cardiac events. Continue reading “FAME Trial Economic Analysis”

FFRangio in Dual/Triple Vessel Disease

Excellent diagnostic performance, with sensitivity, specificity and accuracy all above 92%; FFRangio was 40% faster that wire-based FFR

This prospective clinical study conducted at Gifu Heart Centre, Japan—evaluated the diagnostic performance of FFRangio in 50 patients with dual or triple vessel CAD compared to wire-based FFR. Continue reading “FFRangio in Dual/Triple Vessel Disease”

Learn how the CathWorks FFRangio System can impact your practice.

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