New Devices

Use of the Control Mechanical Thrombectomy System in Lower-Extremity Intervention

CLD talks with George Adams, MD, MHS, MBA, FACC, FSCAI, UNC REX Healthcare, Raleigh, North Carolina.

CLD talks with George Adams, MD, MHS, MBA, FACC, FSCAI, UNC REX Healthcare, Raleigh, North Carolina.

Can you describe the problem of acute vascular thrombosis?

Thromboembolic conditions are estimated to account for approximately 1 in 4 deaths globally and are the leading cause of mortality. Ischemic heart disease and ischemic stroke comprise the major arterial thromboses, and deep vein thrombosis and pulmonary embolism comprise venous thromboembolism. Virchow’s triad is a useful concept for clinicians in understanding the contributions to vascular thrombosis. Virchow’s triad includes stasis of blood, vessel wall injury, and altered blood coagulation. Stasis of blood would include patients that have atrial fibrillation, congestive heart failure and/or cancer, or have a sedentary lifestyle (and/or long plane rides). Vessel wall injury would include patients who have trauma, infection, and/or surgery. Altered blood coagulation would include patients that have genetic deficiencies or autoimmune disorders. Age is a direct correlate to vascular thrombosis. In the 20th century, life expectancy doubled, and the world population quadrupled, so vascular thrombosis is an increasing problem.

What are the related treatment and device considerations for acute vascular thrombosis?

While vascular thrombosis can occur in any vessel in the body, the ones that gain the most attention are those that cause death (heart attack, stroke, pulmonary embolism) or severe morbidity (amputation or severe venous congestion). Considerations for treatment and device choice include first, the ability to reach the target lesion, meaning the distance of the lesion from the access site. We have to be able to reach the lesion. Second, the tortuosity of the vessel. Can the device manipulate the tortuosity and is it flexible? Third, the size of the vessel. If it is a large vessel, does the device have the ability to remove a large thrombus burden? If it is a small vessel, does the device have a low-enough profile to cross? Fourth, is the vessel chronically diseased and does the device have enough support to reach the target area? We must consider, for example, whether the device is a rapid-exchange or an over the wire system.

Therefore, problems and challenges with past devices relate to the following factors:

(1) The device is not long enough to reach the lesion from the access site, such as a lesion in the plantar loop of the foot.

(2) The vessel is tortuous, such as in a coronary vessel, and we cannot manipulate the tortuosity without causing harm.

(3) The aspiration lumen is not large enough to remove a significant clot burden or the device is not small enough to treat smaller vessels.

(4) The device does not have enough support to reach a lesion in a diseased vessel. The shaft is not built with enough support or rapid exchange.

Can you describe Control Mechanical Thrombectomy?

Control Mechanical Thrombectomy comes with a catheter that can be used in both the cardiovascular and peripheral vascular circulation. The nice thing about this device is that it can attach to any catheter for aspiration. Therefore, it is not married to one catheter. If you need a catheter that is more flexible or stiff, longer or shorter, and larger or smaller, you can still use this device to aspirate. The operator controls the aspiration, which is very effective, using a hand squeeze. The aspiration force is strong and the amount of blood removed from the patient is controlled. The device is also very cost effective.

Is there a learning curve for use?

Control Mechanical Thrombectomy is an easy-to-use device with a short learning curve. You attach the device to the catchment bag, then connect the device to the aspiration catheter and remove thrombus. The handle of the device is ergonomically designed and feels much like that of a garden hose nozzle. When squeezed, negative pressure is created and causes a suction at the end of the catheter being used. This action can be repeated as needed to remove thrombus or emboli burden with the same device.

Can you describe your patient experience thus far?

I have had many successful patient experiences using the Aspire device. The device is consistently reliable and produces predictable outcomes when treating thrombus and emboli.

What do you see as the future of this technology?

I believe this device sets the precedent for simple, effective devices that provide reliable and predictable results. This device adds to the toolbox for addressing soft plaque and emboli. The Aspire is cost effective and therefore differentiates itself from other thrombectomy devices that also require expensive capital equipment. 

This article is supported by TZ Medical.

Disclosure: Dr. Adams reports serving as an educator and consultant for Control Medical.

George Adams, MD, MHS, MBA, can be contacted at george.adams@unchealth.unc.edu