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Laparoscopy, LapCap 2, and Beyond

Laparoscopy, LapCap 2, and Beyond: Conversations with Dr. Camran Nezhat and Life Care Medical Devices CEO Richard J. Prati

Mike Ragogna: Richard, people in the medical field already are familiar with the company Life Care Medical Devices. What is the history of the LCMD?

Richard J. Prati: In a nutshell, the company had been around for a while and they had been trying to work on a variation of the LapCap. I was brought in in 2013 to turn it around because they were struggling financially, they had not launched the product and they were having difficulty. I was brought in to square up the debts, raise some funding, and get some key opinion leaders on board, so I set out to try to clean up what was remaining of the company. I worked very hard and we paid off some of the debt, raised some money, and had some investors that were excited. And the biggest accomplishment for me was getting to meet Dr. Camran Nezhat and getting him on board to work with us. That helped us secure a licensing deal with Aesculap.

After that, we’ve been just trying to redesign the product and modify it so we can optimize its use for physicians. We’ve done a lot of clinical work and trials to get the product to where physicians are happy with it. We just recently launched earlier this year when we signed a distribution partner. There’s two parts to the company, the minimally-invasive LapCap part and the other part of the company, we made an acquisition called BioFusionary last year, and that’s an exciting thing we’re still developing.

MR: There’s now the LapCap 2 device. What was the improvement over the original version?

RJP: In the production, the actual difference was to bring down the cost dramatically. Healthcare costs are a big deal, and as they’ve skyrocketed, we wanted to make the effort to make this accessible and affordable on a global basis. Medical malpractice is obviously a big problem. If a surgeon makes a mistake and there’s some kind of complication, it increases the cost dramatically and creates problems for the patient. If we can bring down the complication rate, that’s a huge accomplishment. Since it’s a single use only device, we needed to make it cost effective so that the value proposition for a physician or for a hospital or for a purchasing group. They look at this and say, “For less than fifty dollars, and in light of the cost of surgery, this is a very inexpensive device, which will hopefully increase the odds of success significantly.” On a cost-benefit analysis, it’s a very good risk-reward. Previous versions were much more expensive, so as the cost is higher, if it’s a thousand dollars that’s much too expensive for a single use only device. If it’s a hundred dollars, would we use it? Probably…certainly some physicians. Seventy-five? More inclined. Less than fifty? Absolutely. 

As we were able to bring down the cost and improve the experience for the physician, we did lots of little things. The dome of the device comes down and it approaches the abdominal wall. We flared it out so that it would have a bigger surface area and not cause bruising or hickeys from the suction. Little things include just making the septum bigger so that the surgeon has more control to put the Veress needle through the device at whatever angle they determine is appropriate and they have a bigger surface area to go through so they can go through at the right place and the right angle. It looks like a very simple device but there are a lot of little nuances. It was a brilliant invention by Dr. Nezhat, and I wanted to find a way to bring down the cost, and mass produce it at a lower price so that physicians all over the world could afford to have access to it. Now we’ve really achieved something so that this can become a global standard.

LapCap2-laparoscopy-doctor-Camran-Nezhat

MR: Dr. Nezhat, you adjusted this new LapCap 2 version, but you also invented the original as well, didn’t you?

Dr. Camran Nezhat: That is correct. The most common time for complications and problems during minimally invasive and robotic surgeries is during the portion of the case when the surgeon is entering the abdomen, at the very beginning of the case. The danger here is the potential to cause trauma to the organs. We are trying to avoid all of these complications, especially life-threatening bleeding complications which could occur if there were an injury to the major blood vessles when entering the abdomen. This product has been successful and safe for its initial uses. And we have used it thousands of times.

MR: Can you describe the device’s intention?

Dr. CN: This product facilitates a surgeon’s efforts for all minimally-invasive endoscopic surgical procedures. Whenever a surgeon want to remove a prostate, a gallbladder, the appendix or a large cyst in the abdomen, when he or she wants to perform a hysterectomy or bowel surgery, for surgery of the kidney or liver, in this day and age the surgeon will want to do it minimally invasively. This benefits the patient so significantly both in the safety of the procedure itself and in how the patient heals remarkably better. That is why there is the tremendous need for this product, because it helps the surgeon minimize complications during any of these or any other minimally invasive surgery.

MR: What have you found to be the success rate using this device? Are there other devices you can compare this to for perspective?

Dr. CN: There is no device like this on the market so far. There are multiple other ways to achieve the same goal of gaining laparoscopic entry to the abdomen, which are the current methods being taught and utilized every day, but their risk of complications is demonstrably higher. Many surgeons may be too proud to admit it, but entering the abdomen at the outset of the surgery might really be scary to them, the most challenging moment of the case. In our experience, it is easier and safer to use this product, and you can teach and master this technique much more easily and more quickly. In this day and age, the number of surgeries in general has significantly decreased because of improvements in chemotherapy, medical therapy, radiation therapy and other excellent non-surgical interventions, and the repercussions of this is that the surgeon’s level of experience and consequently abilities comfort goes down. We need enabling devices to help surgeons perform their procedures more safely. The LapCap2 is an enabling device to make it easier for surgeons who don’t have a large volume of experience. It is also a great device medical students or residents starting their practice, to introduce another safety measure during their training.

MR: How will the device ultimately benefit laparoscopic surgery?

CN: This is going to make things much, much easier for the surgeons. It makes it bulletproof, so that the surgeons know that they initiated their surgery safely, that they entered the abdomen in the right place. Especially at teaching institutions and universities, this will make students learn things much, much more safely and quickly. They’ll have a bigger target when they operate, which will give the surgeon peace of mind.

MR: How exactly does it work?

Dr. CN: You put the device on the abdomen, right over the belly button. The instrument lifts it up and gives you a lot more area to enter the abdomen, and it creates a distance between the belly button and the major blood vessels in the back. When you lift up the belly button you have almost no risk of injuring the blood vessels. With this distance that it gives you, it’s like going from having one belly button to fifteen belly buttons― you have a lot more space and safe leeway to get into the abdomen safely.

Richard J. Prati

MR: Richard, how did you and Dr. Nezhat begin your association?

RJP: I was attending a minimally invasive surgery conference in Las Vegas and was eager to meet Dr. Camran Nezhat, the “Godfather of Laparoscopic Surgery” and the inventor of “LapCap.” I was the recently appointed CEO of Life Care Medical Devices, and was eager to meet the physician I was told would be among the most prestigious surgeons, if not the most prestigious surgeon in the space. I had asked a consultant with expertise in laparoscopy and minimally-invasive surgery to introduce me to Dr. Nezhat and several other physicians in the space.  We had created a modified version of the original LapCap, that was much less expensive and simplified.

Initially, Dr. Nezhat was flummoxed when we met and I showed him our version of the LapCap, as he was concerned we might be infringing on his idea and concept for LapCap. I assured him that I was brought in as a turnaround specialist to fix the company, and I had no knowledge of the history and was unaware if my predecessors had violated his IP. After he explained to me that LapCap was sold to Aesculap along with other inventions of his, he suggested that I call and set up an appointment to visit him in his office in Palo Alto to chat more. I was eager to work with Dr. Nezhat, but also concerned that without him, that our IP might not be legitimate so I called Dr. Nezhat’s assistant three times per day for two weeks straight, until she finally squeezed me in for an appointment. She told me, “Dr. Nezhat is booked for the next six months.” So when a cancellation opened up a few days later, I jumped on it.

I was concerned that my IP might not be valid, but mostly I wanted to see if I could persuade Dr. Nezhat to work with us, to be a key opinion leader (KOL) for Life Care Medical Devices and for our newer version of LapCap. I flew in the night before, and spent the entire next day camped out in Dr. Nezhat’s waiting room in case he was either early or late, I did not want to miss my window. When we finally met, we got along extremely well. Having five physicians in my family, he knew that I appreciated the sanctity of medicine and the importance of integrity and reputation. When I explained my intentions, and motivations, he was initially pleased, if slightly skeptical. 

When I flew back to Florida that evening, I spent hours writing a detailed proposal that was both professional and personal and appealed to Dr. Nezhat’s sense of philanthropy, helping others, and trying to do good things in the world. He noticed that I had sent the email at around 3 am, and called me the next day―impressed that I had drafted such a sincere, detailed and personal proposal so quickly. We spoke several times over the next week to discuss ideas and proposals to work together. 

At some point, Dr. Nezhat commented that he was impressed that I was not an MD and yet had significant understanding of laparoscopy, and specifically, gynecological issues such as ovarian cysts and endometriosis―one of his many areas of expertise. I explained that in addition to needing to ramp my knowledge for the sake of my company, that coincidentally, my wife had chronic pelvic pain, and was due to have surgery soon with one of Dr. Nezhat’s protégés in Florida, and that we were uncertain of the precise reason for her pain. Of course we wanted Dr. Nezhat to do the procedure and although his waitlist for surgery was six months long he was kind and took care of my wife’s surgery immediately without any wait. 

MR: Dr. Nezhat, you are considered the godfather of laparoscopic surgery. What is your history with this approach and how has the procedure evolved over the years?

Dr. CN: By the beginning to mid 1970s, laparoscopy was only utilized for diagnostic and minor therapeutic purposes. In the United States, the scarcity of centers and surgeons qualified to participate in laparoscopic procedures was astonishingly low, as compared to today’s statistics: By 1972, there were only approximately 30 U.S. centers in which laparoscopic procedures of any sort were being performed and today it is considered the standard of care even in the smallest of hospitals. Laparoscopy was not accepted as an appropriate means of performing surgery―again, it was just considered useful for looking inside to diagnose something—and I received so much criticism when I proposed we use it to perform actual surgeries. In 1977, the American Association of Gynecologic Laparoscopists (AAGL) released a debate entitled “Laparoscopy is Replacing the Clinical Judgment of the Gynecologist.” At that time it became clear that there was nearly universal consensus that laparotomy―making a large incision to open the abodomen and perform an “open” surgery―was irreplaceable as a surgical modality. Thus, laparoscopy was forced for much too long to remain as a diagnostic tool, using a handheld scope with no attached monitor. I was determined, however, to change the face of surgery—going from open surgeries to minimally invasive surgeries.

MR: How did you first become passionate about laparoscopy and improving minimally invasive surgery?

Dr. CN: As a young high school boy in Iran, my parents sent me to shadow a surgeon. There, I witnessed his first procedure, a cystoscopy. The surgeon struggled to show me the stone within the patient’s bladder, as they hunched over the patient’s body peering through the shaky scope. After four attempts, I was finally able to see the stone in the bladder. I suggested that a camera be placed at the end of the scope and the image projected onto a TV monitor, in order for the whole operating room to see within the cavity. The surgeon simply laughed and stated that no such advancement would be possible. Neither would this be the last time someone laughed at me for my vision, nor did I lose sight of my vision.

MR: What brought you to researching laparoscopy?

Dr. CN: When I started medical school, my professors used the same endoscopic technique that I had witnessed several years prior. However, it was not until one of my brothers required an endoscopic knee surgery that I realized medicine was desperately in need of a change. I carried this passion and motivation with me into my training, where I was able to further transform my vision into a reality.

MR: You are also world-renowned for your achievements in minimally invasive and robotic surgery, reproductive endocrinology, and reversing infertility. Can you give us a little history on some of your most important achievements or contributions to the medical field?

Dr. CN: During residency at the State University of New York, I empathized with countless patients suffering from the postoperative pain and complications associated with laparotomies. In comparing recovery time and pain between laparotomy and diagnostic laparoscopy, I asked myself, “Why shouldn’t we treat more surgical pathologies laparoscopically?” From that moment, I researched the works of pioneers, who shared my similar beliefs that laparoscopy should overcome its diagnostic fate and that it should become the leading operative standard. Inspired by the earlier pioneers’ work such as Dr. Benedict Begigno of Atlanta, Georgia, I embarked on refining laparoscopic procedures in hopes of operative laparoscopy becoming the new surgical norm. Through the ‘80’s and ‘90’s Dr. Benigno was always encouraging of my efforts. “You have a story to tell. Don’t stop, keep going.” 

My goal to change nearly 200 years of entrenched surgical tradition came with great hardships—that is, backlash from the medical community and technology’s status at the time. This did not deject my efforts to improve patient care though. There had to be a surgical revolution. Unfortunately, my vision was too advanced for the technological capabilities available during this period. The available technologies just would not accommodate all the visions in my head. Indeed, my earliest attempts to work off the monitor using video equipment produced such murky images of the abdomen that just about everyone was either laughing or crying.” I maintained my motivation and established relationships with medical device companies, and was finally able to demonstrate the laparoscope’s potential in the operating room. Companies began customizing cameras and light sources for me.

This all took place thirty years ago, when few could see past the seemingly insurmountable shortcomings of video-assisted endoscopy, including its two-dimensional field, encumbered dexterity, and counterintuitive motions. Although I was going against the medical community as a whole, I recognized the deeper significance of laparoscopy, not as a mere technique or technology, but as something that signified a revolutionary advance for medicine and society. When I revealed my development on video-laparoscopy, this sparked nearly twenty years of scorn and ridicule, even though I presented evidence demonstrating the significant advantages of minimally invasive surgery. The days of mockery for me began when I first presented my new ideas of operating off the monitor and demonstrating that the most extensive diseases could be managed laparoscopically. In addition to this, I found myself in a publication purgatory, unable to get any of my work recognized. Any recognition that I did experience only jeopardized my reputation. One review on my introduction to video-laparoscopy boldly asserted that ‘“The authors’ [Nezhat et al] recommendation to operate on the monitor, instead of looking through the laparoscope, is dangerous and irresponsible. It could lead to severe complications and death of…patients.’” All of this ridicule fueled my struggle between the exhaustive extremes of dreaming and doubting.

While it took more than thirty years, the medical community finally came to realize what I already knew. Not only did operative laparoscopy edge into the realm of mainstream acceptance but also new technologies began pouring fourth. Patients were at last being freed from an era where multiple laparotomies were the norm—meaning, minimally invasive procedures overcame its diagnostic fate to finally be accepted as the norm for treatment and cure. With the medical community’s acceptance my operative video laparoscopy, there came forth more opportunity for technological advancements. In order to improve my technique and instrumentation, I developed several tools, and was involved in developing the da Vinci Robot. I was sought out to teach others on how to perform operative laparoscopy, and I have since dedicated my life to teaching and training other surgeons on minimally invasive techniques. Unfortunately, only a small fraction of surgeons can perform some of the more advanced laparoscopic techniques.

For more information on my story, please feel free to refer to a short biography: Carter J. Biography of Camran Nezhat, MD, FACOG, FACS. JSLS. 2006; 10: 275-280.

MR: You also are known for being dedicated to women’s health issues in general, even being involved with related charitable organizations. Which ones are you affiliated with in 2016 and what drew you to these causes?

Dr. CN: I have been in medicine for more than 30 years. Along with my brothers and niece―Drs. Farr, and Ceana Nezhat, and our niece, Dr. Azadeh Nezhat―all of us gynecologic surgeons, together we have more than 100 years between us dedicated to women’s health. During this time, we have witnessed young girls and women suffering immensely from extreme physical and emotional pain caused by endometriosis. To address these unmet needs in the community, our family has started a grassroots organization and we have made it our mission to develop technologies to better diagnose and treat endometriosis, as well as raise awareness about this invisible epidemic so that millions of women and girls can receive a proper diagnosis, quality medical care, and, hopefully one day soon, a much-needed cure. There are only about 500,000 autistic children in the US, but there are more than 10 Million women with endometriosis, and autism is so much more well-known than endometriosis. The Endometriosis March not only works to improve these women’s health, but helps empower the women themselves to raise awareness of this tremendously significant cause.

MR: Can you tell us more about why you are so passionate about researching and treating endometriosis?

Dr. CN: The inspiration for the Endometriosis March was in part when we researched and published on the history of the endometriosis. My brothers and I found that even prominent thinkers like Freud subscribed to myths that were terribly detrimental to women. We demonstrated that Freud’s diagnosis of “hysteria”, the now discredited disorder presumed for centuries to be psychological in origin, was most likely most often actually endometriosis. Unfortunately, even today, so many women suffering from endometriosis are still told that the pain is “in their head;” this centuries-old notion linking chronic pelvic pain to mental illness has continued to exert tremendous influence on attitudes about women with endometriosis in modern times, contributing to diagnostic delays and chronic indifference to their pain even today.

As we said in our article, “Endometriosis: Ancient Disease, Ancient Treatments,” “The clock is definitely ticking, as we know millions of women still live lives awash in anguish, just as they did thousands of years ago and just as they will centuries from now unless we steer ourselves faster toward the long-elusive cure. Four thousand years is long enough; the time has come to end the empire of endometriosis.”

On behalf of me and my brothers, we invite all your readers all around the world to come out and join us for the annual Worldwide Endometriosis March 25, 2017. For more information, you can go to: http://www.endomarch.org/.

MR: Where else is your focus these days?

Dr. CN: I have been trying to innovate and make minimally invasive surgery more accessible to the operations of the people of the world, make it better and faster and more economical, because, simply put, minimally invasive surgery has better results. That has been my goal and I have developed many products and instruments to provide a means to that end. I’m working on a couple of other areas, a major one of which is surgical robotics.

MR: What do you see as the future for minimally surgery?

Dr. CN: As my brothers and I have said for decades, in any body cavity, endoscopic surgery is possible and usually preferable. The limiting factors are the skill and experience of the surgeon and the availability of proper instrumentation. This includes organ transplant as an extreme example, wherein at least a great part we can even perform now by minimally invasive surgery, though still many centers are not doing so. Some of the most advanced procedures, that 20 years ago we showed can be done by laparoscopy with all the benefits of a quicker recovery, are still being done by laparotomy.  For the future of minimally invasive surgery? Gradually such procedures are going to be converted to always being performed by laparoscopy. Unfortunately now, what takes some surgeons to perform laparoscopically 5 hours, we can do in 45 minutes. As time goes on, all of these major surgeries will be converted to minimally invasive surgery and this will necessitate better training of all surgeons and gynecologic surgeons.

When there is a marathon, everyone runs, and although they are running in the same race, someone is always all the way in the back and someone is always in the front. But everyone runs. Right now everyone is trying to do minimally invasive surgery, but some of us have led the way, others are following, and they have a ways to catch up. We have opened up the landscape for all the people around the world.

The future of the technology is expanding exponentially now. Surgery in the next 10 to 20 years will be totally different. At long last, more and more surgeries are being performed laparoscopically and there will consequently be more and more enabling devices, like next generation robots. That will allow more of these surgeries to be done minimally invasively by bringing the minimally invasive potential to even surgeons of more average experience and skill levels. Almost everyone now can see that advantages of minimally invasive surgery are exposure, magnification, and operating very close to the operative field, along with the supremely important fact that the postoperative recovery is so significantly better for patients. In the future, we will have procedures that robots will do nearly fully on their own, and surgeons will act as a moderator to ensure safety.

The age of surgery and medicine as elite institutions behind closed doors in ivory towers is behind us. On our website, we provide copious amounts of information and up to date articles for patients and physicians alike, primarily about minimally invasive surgery and endometriosis. We invite anyone to peruse the site: Nezhat.org.

MR: What advice do you have for those wanting to pursue a career in medicine or surgery? 

Dr. CN: It has always been said that the pleasure of helping people is greater than any other pleasure. To help other people is greater than any other good deed in the world. Those who have gone into medicine over the areas have been altruistic and it will continue to be that way. When you give a person your help, no amount of money can repay the satisfaction you feel as the doctor.

MR: And what would you say to doctors desiring a career in surgical work, wanting to explore more progressive treatments perhaps utilizing devices like the LapCap2?

Dr. CN: The revolution of minimally invasive surgeries for the past thirty years has made it so about thirty to forty percent of major surgeries are performed minimally invasively. We have about sixty percent more to go to drastically eliminate major surgery and convert everything to minimally invasive surgery, because it has so much more benefit to the patient. There are much better results, the patient goes home the same day or the following day versus spending up to a week or more in the hospital, incisions are much smaller, the patient goes back to work in about a week instead of six weeks…the benefits of minimally invasive surgery are truly wonderful to the patient and to society. All of our efforts should be to do as much as possible to convert all major surgeries to minimally invasive surgeries. That will happen with innovation. With enabling devices, the sky is the limit.

MR: Will your clinical trials be performed overseas?

Dr. CN: There is a race for the enabling devices for minimally invasive surgery that we are developing now, between different companies in different countries, because they know minimally invasive approaches are so much more beneficial to the patient. The combination of high-tech and self-monitoring techniques that we call “wearables,” and surgical techniques are being tested in the United States and around the world and are rapidly going to change. Virtual reality surgery, telemedicine… It’s already here, and it’s going to get better and better.

MR: Richard, what else do we need to know about LapCap?

RJP: To wrap up with LapCap, I just want to make sure we communicate what our goal is: To standardize the process of Veress needle access and for minimally invasive surgery. It’s great for many applications. We’ve done a lot of anecdotal and personal research into other countries, and spoken with physicians throughout South America. We have the CE mark so we can distribute this in Europe. Our view is that this is something that can become a global standard for access, because the idea is if we can just reduce those complication rates that Dr. Nezhat was talking about, this is a great thing for humanity. It’s also great for the hospitals, because the expense of just one complication is tremendous, not to mention the terrible inconvenience and pain and suffering that a patient is going to have from staying at the hospital longer and potentially having an abscess or even death, and then the medical liability associated with all that. It’s our objective to bring down health care costs and do things with as little invasiveness as possible.

There are a lot of physicians who do open surgeries because the alternative of going in with a Veress needle is too overwhelming or too intimidating for them because they haven’t been trained to do it. They’d rather just do an open surgery, and then you end up with a much bigger scar and a much bigger healing time. The idea is that with this, they’ll feel a better comfort level. Even some of the finest physicians that are doing minimally invasive surgery now, the alternative to our device is to use a clamp, which can cause bruising, vascular injuries and so forth, or pinching it with your fingers. LapCap makes a larger target zone and a greater likelihood of avoiding complications. If we can get all surgeons to begin using this as a process for access we think that this is going to be a tremendous benefit to the medical community. That’s kind of the view on LapCap.

The other device that fits with this very nicely is the LCMI. We made an asset acquisition last year of a company called BioFusionary. We’re going to re-brand it because doctors weren’t happy with the brand name, so we’re in the process of trying to get some FDA indications. It’s already FDA approved, so we do have two FDA approved devices, LapCap and the LCMI. The LCMI sends RF energy through electromagnetic induction coils in a handset. It’s FDA approved for muscle therapy, so it generates heat beneath the skin and in the muscle. It’s a great therapeutic device, much more effective than diathermy and other older technologies. We are applying to get FDA indications for things like aesthetics and wrinkles, because anecdotally, the original inventors of the technology were trying to cure incontinence because they found they were getting good muscle response in the pelvic area in older patients. They noticed it had a tremendous aesthetic effect and a tightening of the skin, so they went about it in a different way and got their FDA indication for muscle therapy and the application of heat because that was the fastest way to get approval. Now they have a device that they can sell for those purposes, so our next goal would be to continue that research in clinical trials to get wrinkles, aesthetic, and then do the clinical work to try and cure incontinence.

This modern energy device―as we call it―can be used for applications like vaginal tightening and potentially with the application of a polymer stopping a blood vessel―either in a trauma ward or in military applications what we envision is, hopefully, having the ability to stop a blood vessel that’s been severed with a polymer and a quick dose of electromagnetic induction. We think we’ll be able to do that at some point. We have a future pipeline of things that we want to do. We’re a research, innovation, product manufacturing company and so far we have two FDA approved products with plans to do a lot of great things in the future and go after some very big markets that are really in need of being addressed.

Transcribed by Galen Hawthorne

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THE ORIGINS OF MINIMALLY INVASIVE SURGERY