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Launch of the Mynx Ace Closure Device: An Interview With Aref M. Rahman, MD, FACC, FSCAI
Aref M. Rahman, MD, FACC, FSCAI, is director of the cardiac cath lab at VA Pittsburgh
Healthcare System and Assistant Professor of Medicine at the University of Pittsburgh Medical Center. Dr. Rahman reports receiving honoraria for educational roundtabe discussions from
AccessClosure, Inc.
In March, AccessClosure Inc. (acquired in May 2014 by Cardinal Health) commercially launched its Mynx Ace Vascular Closure Device, a vascular closure product with a new deployment system to seal femoral artery access sites. Mynx closure devices are designed to provide gentle vascular closure without the use of cinching, sutures, or metal implants. With Mynx Ace, physicians can close femoral artery access sites with a three-step deployment. The Mynx Ace system uses AccessClosure’s proprietary Grip Technology, which employs an extravascular sealant that actively adheres to the artery for safe and secure mechanical closure and dissolves within 30 days. Vascular Disease Management spoke with Aref Rahman, MD, director of the cardiac cath lab at the the VA Pittsburgh Healthcare System about the use of the device.
Q:Could you describe your experience with using the Mynx Ace closure device?
A:I’ve used Mynx vascular closure devices from the first generation all the way to their newest or most recent upgrade. The first generation was called the Mynx, the second generation was called the Mynx Grip, and the third generation Mynx Ace uses the same grip technology as the second generation, but the delivery system is simplified. I think it is an excellent closure device because it is extravascular, provides the same safety and efficacy in terms of achieving hemostasis, and can be used in a wide variety of patients. I’ve had an excellent experience with it thus far and have used it in more than 150 cases.
Q: So what have you found to be the advantage of this over other closure devices?
A:One of the advantages of this device is on patients who have extensive peripheral vascular disease, or for patients with a femoral access site below the bifurcation; you can use this closure device because it is extravascular. You don’t have to worry about the amount of calcium that is inside the vessel. As long as the balloon remains intact, you should be able to achieve hemostasis. In terms of efficacy and safety, I think it is similar to other devices in achieving hemostasis, but it is extravascular.
Q: Could you describe the physical components of the system and how it might differ from others you’ve used?
A:The sealant is composed of two different components of polyethylene glycol. The tip of the sealant is unreacted and not cross-linked, and the body temperature and pH level causes it to be reactive and interlock with the contours of the vessel wall. This is the grip component. The additional sealant component consists of cross-linked and reactive polyethylene glycol that is freeze-dried and porous, which absorbs the blood and subcutaneous fluids and expands 3 to 4 times, filling the tissue tract.
Q: Are there still any challenges to overcome in devices for access closure?
A: I think there has been a tremendous advancement in the development of access closure devices. Ideally, we would want to have a device that is very comfortable for the patient and is mostly extravascular but provides excellent safety and efficacy in achieving hemostasis. We also want to be able to use it in a wide variety of patients and I think this device comes close to that.
Q:Any tips and tricks you’ve learned since beginning to use it?
A: For patients with peripheral vascular disease, I recommend filling the balloon with 50% contrast and 50% saline mixture so that one can observe the balloon as it is being retracted in the vessel under fluoroscopy until they anchor against the arteriotomy. If the balloon remains intact and is not affected by the calcified plaques, there is a good probability that you will be able to achieve hemostasis. This is a technique I have often used and has provided good results.
Q:Any other important points for vascular specialists to know about the Mynx Ace?
A: The Mynx Ace is simple to use. It provides more consistency in deployment when compared to the prior generations as it takes away the operator variability in terms of how much pressure one has to apply. I recommend that the operators look at the video and understand the concept and basics involved in the deployment of this device.
