© 2025 HMP Global. All Rights Reserved.

Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of EP Lab Digest or HMP Global, their employees, and affiliates.

In this informative discussion, Dr. Sunil Kapur from Brigham and Women's Hospital and Dr. Cyrus Hadadi from MedStar Heart and Vascular Institute explore the features of EluPro, Elutia’s advanced antibiotic-eluting BioEnvelope. They highlight EluPro's innovative combination of trusted antibiotics (rifampin and minocycline) and a biologic extracellular matrix (ECM), which they note reduce infections, inflammation, and fibrotic complications associated with cardiac implanted electronic devices (CIEDs). Designed for diverse patient populations—from those with high infection risks to patients with fragile tissues—EluPro offers a powerful new standard in device implantation, combining antibiotic protection with regenerative medicine for superior patient care.

Sunil Kapur, MD: Hi everyone, my name is Sunil Kapur. I am a clinical cardiac electrophysiologist at the Brigham and Women's Hospital in Boston. At the Brigham, I helped lead our advanced lead management clinic and our cardiac implanted device clinic. I spent a lot of my time doing advanced device procedures and most of my research is in clinical innovation around novel devices. I am joined by Cyrus today.

Cyrus Hadadi, MD: Thanks, Suni. Hi, I am Cyrus Hadadi. I am a clinical cardiac electrophysiologist at MedStar Heart and Vascular Institute in Washington, DC. My areas of academic and personal interest are complex devices, lead management, and when necessary, extraction procedures. 

Sunil Kapur, MD: So, Dr Hadadi, to get started, I know you and I both have a lot of interest in lead management and spend a lot of time doing device extractions. Tell me a little about your experience about the clinical and unmet needs around healing around the pocket with regard to infection and fibrotic tissue. 

Cyrus Hadadi, MD: Sunny, I think that is a fantastic question, and as you alluded to, there are tremendous needs and unmet needs when we talk about device management and infections. We know from Dr Carrillo’s data,^1,2 for example, that almost 12% of cardiac devices will experience a complication very acutely, and many of these complications involve infection. So, for me, EluPro has been a game-changer, because you have both acute and chronic management of complex devices and infection. You have the proven synergistic benefit of rifampin and minocycline, but in addition, you have an envelope that handles very well, is soft, conforms to a generator, and has the proven benefits of a biologic extracellular matrix (ECM), which gives you long-term suppression of inflammation and better wound healing, less fibrosis, less scarification, and hopefully less need for extraction. However, if you do have to extract, it is a safer extraction procedure.

Sunil Kapur, MD: I totally agree with you, Cyrus. From my mind, I think for a long time we have put in pacemakers, defibrillators, and other technology, and really allowed the biology to do its own thing. We put it underneath the skin and hope for the best, and for most patients, we get away with it. But like you pointed out, I think there is a significant number of patients who do have complications. Infection comes to mind because that is grossly apparent when that happens. But I think there are some other things that really affect patients that we sometimes don't necessarily account for, whether that be pocket hematoma, shifting of the device, or other restriction in mobility. I think it is only recently that we have started to address that or started to work to address that with other additives into the pocket. We all are familiar with novel additives to the pocket like powders and injections, and these envelopes have become more and more apparent, which have allowed us to really iterate on how we want to handle and kind of navigate that biology.
Antibiotics are an obvious step that kind of address some of the basic concern for infection, but I think what's incredibly exciting is not just limiting ourselves to antibiotics, but also kind of harnessing the biology of regenerative medicine, like you said, using that ECM to create what we would consider a healthy capsule as opposed to that calcific, fibrotic capsule that we unfortunately deal with for some patients. I think synergizing those 2, the antibiotics and the ECM, is an incredibly important advantage that we now have available, which even a year ago we did not, so I think it is a big step forward for sure.

Cyrus Hadadi, MD: Sunny, I think you are absolutely right. Hope is not a strategy. You cannot implant a device and hope for the best. With the EluPro ECM, you have that ability to address the root cause: inflammation. I believe if you are able to get inflammation under control with the tremendous benefits of this ECM regenerative matrix, you are able to, as you said, prevent calcification, prevent fibrosis, and prevent the formation of a truly hostile capsule. We all know that a generator exchange is never just a generator exchange, but the use of EluPro helps us to help ourselves and our patients in the future.

Sunil Kapur, MD: Yes, I think that is very well said. The other thing that comes to mind about it is the usability. When I have colleagues who are implanting devices, some will say that most of the time they don't need an additive—people do well. I think that is true to some extent, but we are in an era now where we are implanting on the extremes of the health spectrum. We are implanting in much sicker patients than we previously did. We are also dealing with much younger and healthier patients when we have these novel genetic diagnoses. It is not familial cardiomyopathies that we are trying to protect people from. But I think that trying to use these type of additives and envelopes can be really beneficial for those patients who are not the standard patients we have dealt with. Also, I find that the EluPro would be much more usable than other additives, just the way that we actually are putting it into the pocket. What has your experience been with that?

Cyrus Hadadi, MD: To tell you the truth, Sunny, I work in a wonderful institution where I have never felt any pushback against advocating for any intervention that I think is right for my patient. So, I use the EluPro in every single patient. But I think populations where you will find particular and specific benefit, of course, are patients who are predisposed to infection, history of infection, immunocompromised diabetes, end-stage renal disease, and frail/thin patients with low body mass index, and especially in women, who on average tend to be smaller than men and have less tissue. I think the benefits of a regenerative ECM matrix right here allow you to have better long-term wound healing and a better pocket.

Sunil Kapur, MD: I think that is very well said. I also find a population that is incredibly helpful to use that for is the subcutaneous or extravascular defibrillators, and obviously, that space is evolving. There are a couple advantages in my mind, number one being the ability to use an envelope as an envelope and to help with the stability and positioning of the device. As we are all aware, movement of those devices might be a little more nefarious for the overall electrical health of the system. The other thing that is fantastic is those devices tend to be a little bigger, and so as you said, having that minimized fibrotic inflammation since the opportunity for infection is worse with a bigger device, and really negating that as much as you can is really helpful. We have also done some work at our institution looking at the electrical health of the subcutaneous defibrillator over time, and as that fibrotic capsule develops, whether or not that increases your shock impedance and makes it so you have less success in defibrillating the patient, which is something that many people have observed for these chronically implanted devices. We have done some work that has shown that if you implant it, you see an envelope and kind of reduce that thick fibrotic capsule, you are able to “protect” the shocking impedance and hopefully protect the defibrillation health of the device. So, for me, in addition to all the patients you mentioned, I do it with 100% of my subcutaneous or extravascular implantable cardioverter-defibrillators (ICDs), with the idea being that it not only helps the patient but also helps the defibrillator’s electrical health as well.

Cyrus Hadadi, MD: I think that is an incredibly sophisticated approach. I will tell you, anecdotally, it seems to me that my generator exchanges, my revisions, and as you said, my subcutaneous patients, come back to clinic with less complaints, less discomfort, better wound healing. When you do have to re-operate, for example, years later for a generator exchange, I tend to find that those pockets are very benign. There is a thin, lovely capsule as opposed to these very aggressive, heavily calcified capsules that predisposed to capsulectomy, hematoma, and subsequently infection. Has that been your experience?

Sunil Kapur, MD: I think that has very much similar that we have experienced, again, from the envelopes that we have implanted in the past, having gone back for generator changes, early battery depletion, lead revisions, and lead additions, we have seen that as we might hope to see: a thin, vascularized capsule as opposed to eggshell calcification, calcific capsule. That is incredibly important. It makes the procedures a lot less painful to patients, less painful for you and I when going in there, and I think in the long term, if we were to spin it forward for 10, 15, or 30 years later, for some of our patients who are living longer and doing better, that really is kind of paying it forward to ourselves now in terms of how we handle their pocket.

Cyrus Hadadi, MD: That is exactly right. Also, from the perspective of lead extraction, and as lead extractors, we are in the minority in the overall EP community, and every time I implant, I think to myself, what will happen if I need to extract this device? As extractors, calcium and fibrosis are our worst enemies. I think using the EluPro helps to prevent that vicious circle of calcification, especially in that subclavian space, where otherwise, our laser or mechanical tools can hit a hard stop. Do you have any thoughts as a fellow extractor?

Sunil Kapur, MD: No, I completely agree. I think there are definitely cases that I have had where dissecting the leads out of that calcific pocket takes just as long as actually stepping on their laser or cutting that with your rotational tools, and that can be a stressful point of the procedure as well if you are trying to protect the integrity of the leads. So, I think anything we can do to kind of keep that simplified and healthy definitely benefits us as well as the patient. 

The other thing that I think is that EluPro does have advantages in just the ability to use. When I use it, and I am curious with how you do it, I don't necessarily cut it up into pieces, cut the edges, or go inside out. I will soak it in a solution to kind of take it a little bit softer, fully plant the device and the leads into the envelope, and then tie it down through the eye of the device as well as the EluPro. I am impressed by how easy and malleable it is, and the fact that you don't need to make it an arts and crafts project where you need to rip it into small pieces or cut it into different shapes. You can just insert it over the device. It forms to the spot that you have already made.

Cyrus Hadadi, MD: I agree with you 100%. EluPro conforms and handles so nicely. With the other product, I find myself doing a lot of unattractive things like extending an incision or turning it into a taco by having my tech cut half of it open, like you said. We never run into these problems with EluPro. It handles beautifully. 

Sunny, how would you describe EluPro to a colleague or friend who has never heard of it or used it before? When I talk to my cardiovascular technologists (CVTs) and partners, I describe EluPro as a grail product, something we have been waiting for a long time that meets several of our needs. It is the proven benefit of antibiotics, but in addition, it is a biologic ECM. It is a scaffolding for the patient's own body to regenerate tissue around the generator. Is that how you would think about it?

Sunil Kapur, MD: I think very similarly. I mean, I think you and I are very understanding of the fact that we are not regenerative biologists, and most of the electrophysiologists that we speak to are not. I think of it very simply in a similar way that is the antibiotics, similar antibiotics, and antibiotics to other devices that we have used in the past, so we know that it has a benefit. It elutes over the course of a week and gives us that protection. In addition, as opposed to having the antibiotic be on a synthetic product, it is on a biologic product. 

Cyrus Hadadi, MD: I think that is huge. 

Sunil Kapur, MD: That ECM allows for the patient's own body to scaffold, as you said, on that, as opposed to a thick fibrotic capsule, a vascularized healthy capsule that we might want to see for most of our patients. I think that kind of combination with antibiotics on a biologic matrix allows for a little bit of the best of both worlds, as you alluded to.

Cyrus Hadadi, MD: We often, as Americans, are blessed to live longer, have patients who are 93, 95, or 102 and need a pacemaker, and I worry about erosion of that generator through that very thin chest wall tissue. EluPro gives me confidence that we can create a scaffolding for the body to build around. I think there is less risk of erosion and better wound healing overall.

Sunil Kapur, MD: Yes, I think we have anecdotally used it in similar cases and kind of have had the same opinion that I think this will allow for healthy tissue to be developed, even in those incredibly frail or sick patients. Obviously, we are collecting data as a collective team and trying to see how that bears out over time. Certainly, I think the more data we are collecting and the more anecdotal experience we have, I felt very positive about it for those specific use cases for sure.

Cyrus Hadadi, MD: That is in part why I advocate for EluPro. I want my partners to use it, because I want us to have more data about its long-term outcomes. I really feel very confidently that in my own practice, my patients have more cosmetically attractive pockets, healthier pockets, and more robust freedom of motion at the joint, and I think a lot of it is due to EluPro. It would be nice to have my own partners adopt it and then get real meaty long-term data to that effect.

Sunil Kapur, MD: I think you are right. That is something that we are certainly looking forward to better understanding. It is always a challenge. Fortunately, infections are low, even in the majority of our sicker patients, and so it will take time for us to develop all that data. The time horizon over the course of 1, 2, or 3 generator changes is fortunately very long, but I think the more we are seeing, the more we are learning, and the more we are experiencing has been very positive in our experience and in other folks that I have talked to.

Cyrus Hadadi, MD: Great. So Sunny, as we wrap up in our remaining time, I started off our talk by describing EluPro as a grail. It meets several of our known and unmet needs. It offers antibiotic control, handles beautifully, and provides a really robust ECM scaffolding for better wound healing for our patients. How do you feel about it?

Sunil Kapur, MD: I think very similarly. I think of it as a new advancement. We previously had an antibiotic pouch, which of course, has benefits with regards to reducing infection, and we previously had an extracellular envelope that had benefits with regards to the regenerative healing and how that pocket was going to form. As of today, we kind have a synergistic combination of both to hopefully better suit and help our patients on both fronts.

Cyrus Hadadi, MD: I use EluPro in every patient. 

The transcripts were edited for clarity and length.

This content was published with support from Elutia.

Disclosures: Drs Kapur and Hadadi have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Both physicians have no conflicts of interest to report regarding the content herein.

References

1. Rodriguez Y,  Garisto J, Carrillo RG. Management of cardiac device-related infections: a review of protocol-driven care. Int J Cardiol. 2013;166(1):55-60. doi:10.1016/j.ijcard.2011.09.071

2. Dai M, Cai C, Vaibhav V, et al. Trends of cardiovascular implantable electronic device infection in 3 decades: a population-based study. JACC Clin Electrophysiol. 2019;5(9):1071-1080. doi:10.1016/j.jacep.2019.06.016

Please note: Elutia’s XL and XXL BioEnvelope sizes are offered for CanGaroo at this time. These sizes are not yet available for EluPro. Availability may change—check with an Elutia representative for current information. www.elutia.com/elupro