Written by Kymberlie McNicholas, Founder of The Way to My Heart
“If there is an atherectomy procedure being done with a lesion in a high-risk area, a filter is something that could be considered.” explains Ryan Egeland, MD, Chief Medical Office for Cardiovascular Systems, Inc. (CSI).
As part of our ongoing Vascular Innovation Series in conjunction with The Way to My Heart, Emmy Award-winning Journalist Kym McNicholas interviews Cardiovascular Systems, Inc (CSI) Chief Medical Officer Ryan Egeland, MD.
Dallas had multiple toe amputations and was faced with the loss of his entire foot. He got a second opinion from an interventional vascular specialist who was skilled in below-the-knee revascularization using minimally invasive techniques and tools. His foot warmed up immediately following the procedure but 24 hours later his big toe became discolored and started throbbing. An urgent trip back to the clinic revealed that downstream emboli had lodged in his toe. The vascular specialist commented that this can happen during various procedures such as atherectomy, where plaque is physically removed using mechanical or laser devices. Usually, the debris from the procedure is smaller than a red blood cell so it doesn’t present a problem. But there’s always a small chance that a larger piece of plaque gets lodged in the toe, pushes through the tissue, and results in an infected ulcer that could lead to amputation; this is called distal embolization. Distal emboli have even been documented traveling to the brain and causing a stroke. For this reason, some vascular specialists choose to use filters during procedures that can catch these downstream emboli. The FDA is also stressing the importance of filter use by making it a requirement for companies looking for clearance of atherectomy devices. Cardiovascular Systems Incorporated (CSI), saw a growing demand for these filters and recently introduced the WIRION® Embolic Protection System. CSI’s Chief Medical Officer Dr. Ryan Egeland discusses its potential impact on patients at risk of distal embolization from procedures involving atherectomy.
What need does embolic protection for lower extremities address?
Anytime during manipulation of the patient’s artery, there is a chance that dislodged debris could travel downstream. Most of the time, that debris doesn’t create a problem for the patient. In some cases, it can cause consequences that could include longer procedure times or potentially even amputation. During peripheral vascular intervention procedures, especially atherectomy, embolic protection devices (or filters) are used to collect debris and can provide additional assurance during complex cases.
How does a doctor decide when to use a filter?
The physician must decide on the benefit vs. the risk with each clinical case by looking at various factors such as planned device use and type of lesion. There are risks any time the procedure complexity increases and that would include placing a filter since it adds a small amount of time to the procedure. Using filters requires some training and education to deploy them effectively. They are generally quite easy to use but different filters have different requirements.
What is the potential for patient impact with the WIRION® embolic protection device (EPD)?
WIRION is the newest lower extremity EPD for use during procedures involving atherectomy. It offers benefits for physicians vs. what is currently available. WIRION is Simple, Flexible and Universal.
- Simple since it is a single adaptable filter with one size for quick selection. It does not require complex sizing charts. Physicians and lab nurses/techs have continued to comment on how easy and simple the product is to use.
- WIRION is a very flexible filter since it can be used with any 0.014” guidewire. The guidewire is a key component of the interventional procedures and with WIRION the physician can use the one that they prefer for that case and patient.
- Universal – WIRION has shown safety and effectiveness with more peripheral atherectomy devices vs any other lower extremity filter. This is beneficial since the physician does not have to worry about product compatibility as some filters are only compatible with certain atherectomy devices.
What is the story behind the technology?
CSI® also offers an orbital atherectomy device. Before receiving FDA approval, both safety and efficacy were demonstrated without using a filter. The clinical data shows a filter is not needed but there is still a portion of CSI’s physician customers that use a filter since they like the reassurance it provides during certain cases. Having WIRION® available also gives physicians using a different atherectomy device the option to select another filter.
If a patient is going to have a minimally invasive peripheral vascular intervention what should they ask their physician?
It is important to understand your disease, how it is going to be treated, and options for treatment. For those that have further interest, it is appropriate to ask the physician about their approach to the revascularization, what device(s) will they intend to use (atherectomy, balloons, stents, filters), and their outcome expectations. If there is an atherectomy procedure being done with a lesion in a high-risk area, a filter is something that could be considered. If a physician does not plan to use a certain device (such as a filter) you can inquire about the clinical logic behind that decision. It is up to the physician to explain the procedure and make sure the patient feels good about the overall approach.
What is CSI’s Mission and what is next for the company?
CSI is expanding its portfolio of peripheral and coronary artery disease solutions to offer a comprehensive approach for each patient. Their focus is on helping physicians conquer the most difficult disease states given the complications it presents for the millions who suffer. An important role CSI plays is educating physicians on how to use the devices to offer the best outcomes for patients. CSI is also investing very significantly in physician and customer education programs. Patients first must be aware of the disease before they can demand better treatment. CSI takes its mission statement of “Saving Limbs. Saving Lives. Everyday.” very seriously and is committed to developing innovative enhancements to improve the quality of care and expand the number of patients with coronary artery disease (CAD) and peripheral artery disease (PAD) that can be treated.
This interview was produced by The Way To My Heart in partnership with Vascular Cures. Neither The Way To My Heart nor Vascular Cures endorse any specific products, entrepreneurs, companies, organizations, drug or device trials, and/or healthcare professionals, including diagnosis or treatment programs. The information, advice, and views shared in this interview are that of the individual speakers and are offered for educational and informational purposes only.
This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Don’t act on any information provided in this interview without the explicit consent of your own healthcare provider who knows your situation best.
If you think you are having a medical emergency, please go to the nearest emergency room or dial 911.