Ethicon is a company that is a part of the Johnson and Johnson family of companies. Their main focus is developing new technologies to advance innovation in surgery, whether it be technology to simplify suturing or in this case, a topical hemostat to stop problematic bleeding. After their recent FDA approval for liver surgery, we had the opportunity to do a follow-up interview with Dr. Xiao-Yu Song, the Vice President of R & D for Ethicon Biosurgery. Below, we discuss the development of EVARREST in greater detail as well as what the new FDA approval means for patients as well as surgeons. Following, we interview Dr. Amy Kwok, an Assistant Clinical Professor, Department of Surgery at the University of California San Francisco Fresno, who has used EVARREST in clinical practice.
Josh Chen, Medgadget: To start, can you summarize what makes EVARREST such an innovative technology?
Dr. Song: EVARREST is a prime example of an innovative technology because it is a combination of different components. For example, the biologic components, in this case the human plasma derived fibrinogen and thrombin combined with a matrix is combined with the patch component that has two different biomaterials. The making of this product as well as being the solution to an unmet need of problematic bleeding also adds to EVARREST’s value. There are no bloodless surgeries today, whether tumor recessions, removing diseased portions of organs, and/or closing the patient up, every step of the way, surgeons can encounter various bleeding situations. These situations can become extremely dire especially when the surgeon is not expecting it, and sometimes surgeons cannot even tell where the bleeding is coming from. EVARREST can be used to allow surgeons to reliable and rapidly stop bleeding on the first attempt even on special patients with their own coagulation deficiencies. The solution to the unmet need of problematic bleeding as well as the making of the products with the combination of the components makes EVARREST a very innovative technology.
Medgadget: Can you speak a little bit about the R&D process and how the original idea came about?
Dr. Song: Going through a very high level of the R&D process, we started with trying to solve an unmet need. We typically go out to customer emersion, where our R&D team and medical staff go speak with surgeons. Typically, we don’t just talk with US surgeons but also talk with surgeons outside the US to understand what are the barriers for them to carry out the surgeries smoothly with high degree of confidence to complete it on time and with a good outcome from the patients’ perspectives. With EVARREST, we understood through these conversations that problematic bleeding can be a real show stopper not just with the surgeon but also with the OR staff. When these situations happen, the atmosphere in the OR becomes extremely tense. We then looked at the requirement of what the surgeons wanted in their hands to solve the problem. We took that customer requirement and got product development input where it came out with a solution to meet those requirements.
Medgadget: What kind of expertise was needed to develop this technology and what was the team make up?
Dr. Song: With this technology, due to its unique combination of both biologics and biomaterials, we actually had a cross functional team. For the functioning perspective, it needed to be represented by a team with includes Rand D engineer, process engineers because we need to know how to make it, quality engineers, and regulatory. No doubt from R and D, we included the engineers, and clinical professionals who knew how to do clinical trials, and medical professionals. A support team for commercialization and back end for expertise in launching the product to maximize the value this product provides to the customer. In this case, we also had cross sector collaboration. We engaged the pharmaceutical sector who had biologic development experience. Later, when we needed to gain insight and input, we’d ask them again although they weren’t technically a part of the core team.
Medgadget: What is the greatest improvement that you’ve seen with the device since the idea was first conceived?
Dr. Song: I would say the simplicity of the product. With all the components in this device put on one patch, when the surgeon or nurse opens up the package that has the patch, the nurse literally only needs to hand the surgeon the patch and can immediately apply to the wound with minimal effort. The greatest improvement has been the ease of use and convenience that it offers the surgeon. The other piece I would say is that what we’ve been able to achieve with product performance criteria and feature perspective, it allows this patch to adhere to tissue surfaces really strongly. For a product to stop problematic bleeding, the product needs to stay on to the wound and no get washed off by the blood. The ease of use, high conformability to any tissue tomography, and high adherence are the key improvements that this product offers that the current standard of care cannot offer.
Medgadget: What does the FDA’s recent approval for liver surgeries mean for patients?
Dr. Song: EVARREST is currently indicated as an adjunctive hemostat for controlled bleeding during adult liver surgery and soft tissue bleeding for open procedure when standard surgical methods for controlling bleeding are ineffective in the US. In the EU, EVARREST’s indication is for general hemostasis. Liver surgery in patients who come in with comorbidity with different kinds of diseases and a lot of patients have Hepatitis, whether Heptatis B or C, they may come in with cirrotic livers. Many clotting factors are made by the liver, so when patients come in with those diseases, their liver is already abnormal. Their levels of clotting factors are already abnormal. To expect those patients to have normal coagulation is typically nonrealistic, which is why liver surgery hemostasis products are required to overcome even more hurdles to effectively stop bleeding. Also, many patients come in on multiple medications. Because of their comorbidity, they could be on blood thinners, which can impact their coagulation cascade.
Medgadget: What effect does this product have on how surgeons perform and the outcomes of surgeries?
Dr. Song: I actually have a specific example that speaks to how EVARREST is used in surgeries. This story was shared by our chief medical vice president for Ethicon. He was visiting a hospital; they were performing a relaprotomy after packing a patient. This patient was a young healthy in her mid-20s. She had undergone an excision of a tumor about the right kidney, but this type of tumor has nonspecific symptoms of a lot of excess excretion in Catecholamine. As a result, the patient would have hypertension, headaches, palpitations, etc. In some patients, these tumors can be malignant in 20-50% of cases. In this case, recognizing that she had adenocarcinoma with hypertension, it’s harder to stop bleeding. The surgeons realized that the patient’s liver had a laceration. It was really difficult to stop bleeding and the tension in the OR was definitely noticeable since the surgeons had tried multiple ways to stop bleeding. At this poin, they also happened to have our biosurgery sales associate in the OR. He recommended to try EVARREST. The surgeon opted to use it immediately and what’s remarkable was that the surgeon was able to close the patient with high confidence. The patient was able to walk three days later. When our medical leader asked the head surgeon what he thought about EVARREST, he responded saying that EVARREST changed the outcome of the surgery. We have actually heard many stories such as this.
Medgadget: How does the future of this technology look, and will there be any modifications?
Dr. Song: We have gotten indication from FDA for soft tissue bleeding, for liver surgery bleeding, and we’ve just submitted at the end of last week for a general hemostasis indication, where we also included clinical trials. This way EVARREST can be used in all different kind of procedures. That’s the immediate step to get general hemostasis indication. We expect to hear back from the FDA sometime this year. In terms of technology, we are probably going to do more of these types of product innovations now that we know how to do it. From developing a combination product perspective. Couple areas of biosurgery aims to address from an unmet need perspective are postoperative leaks, whether air leak, GI, or neural CSF types of leaks, infection prevention. We’re going to have a lot of unmet needs where we can deploy the “know how” of what we gained from EVARREST and take this combination approach.
We also got to briefly interview a professor and surgeon, Dr. Amy Kwok, who currently is an Assistant Clinical Professor, Department of Surgery at the University of California San Francisco Fresno, and the Associate Program Director of the General Surgery Residency Program at the UCSF Fresno Center for Medical Education and Research, about EVARREST in the operating room.
Josh Chen, Medgadget: How did you first get involved in using EVARREST and why?
Dr. Kwok: I am a trauma/critical care surgeon working at the busiest level I trauma center in California. As a trauma surgeon we are constantly looking for better ways of controlling bleeding in difficult situations such as liver or splenic traumas. I heard about this product through our Ethicon sales representative.
Medgadget: Compared to the current hemostasis standard used in the OR, does EVARREST truly make a difference?
Dr. Kwok: Standard of care is to use suture or cautery for control of surgical bleeding. There are certain instances when hemostatic agents are used in conjunction for control. If used in the right situations, EVARREST as an adjunct allows for quicker hemorrhage control.
Medgadget: What complications have you seen or abnormalities that have occurred in the OR that EVARREST has been able to solve and not other standards of care?
Dr. Kwok: Ability to help control bleeding in places where it is difficult to use sutures and/or electrocautery for hemostasis.
Medgadget: Do you think this device is affordable for common use in hospitals? In undeveloped countries?
Dr. Kwok: I think that this device is affordable in most urban hospitals. It is on the more expensive side when compared to other hemostatic agents but when used in the right situation, it can decrease OR time and transfusion amount which decreases cost as well as improves patient outcome.
Medgadget: Overall, what are your thoughts about functionality of the device? Do you have any interesting stories to share about using EVARREST in the OR?
Dr. Kwok: Several examples of how EVARREST has helped me in the OR:
- Gunshot wound (GSW) to the chest with bleeding from the bullet hole in the posterior chest wall. The intercostal artery bleeding was difficult to control with sutures and electrocautery.
- Raw surface area bleeding on the liver following a liver laceration
- Retroperitoneal bleeding from the psoas muscle following GSW
- Bleeding from the back of the liver, patient was packed initially for hemostasis; brought back to the OR the next day, still had additional bleeding. We had a choice to pack again and bring him back to the OR the next day. Instead, we tried EVARREST and was able to slow down the bleeding enough for us to cauterize the liver and achieve hemostasis
Medgadget: Lastly, are there any improvements that you would suggest for this device? Why?
Dr. Kwok: I would suggest different sizes as well as better identification of which side of EVARREST is to be applied onto the tissue to stop the bleeding.
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