Surg Endosc (2011) 25:2441–2448 DOI 10.1007/s00464-011-1605-5
WHITE PAPER
The Second SAGES/ASGE White Paper on natural orifice transluminal endoscopic surgery: 5 years of progress David W. Rattner • Robert Hawes • Steven Schwaitzberg • Michael Kochman Lee Swanstrom
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Received: 9 January 2011 / Accepted: 1 February 2011 / Published online: 27 February 2011 Springer Science+Business Media, LLC 2011
Background When the concept of Natural Orifice Transluminal Endoscopic Surgery (NOTESTM) was first introduced, many physicians could envisage its potential as a less invasive and more cosmetic way to perform surgery. The
This study was conducted on behalf of The Joint Committee on Natural Orifice Surgery. Members of the Joint Committee are Robert Hawes (co-chair), David Rattner (co-chair), Gregory Ginsburg, Christopher Gostout, Michael Kochman, Michael Marohn, Richard Rothstein, Steven Schwaitzberg, Lee Swanstrom, Mark Talamini, Christopher C. Thompson, Danny Scott. D. W. Rattner Division of General and Gastrointestinal Surgery, Massachusetts General Hospital, Boston, MA 02114, USA R. Hawes Department of Medicine, Medical University of South Carolina, Charleston, SC 29403, USA
potential for harm if NOTES was adopted too rapidly was also readily apparent. To ensure the responsible development of these technologies and techniques and to encourage accurate and honest outcome assessment in humans, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the American Society for Gastrointestinal Endoscopy (ASGE) assembled a Joint Committee to serve as a working group to review the issues involving NOTES. This working group subsequently published the ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery White Paper [1, 2], which laid out the fundamental challenges to be addressed and outlined a pathway for the responsible development and evaluation of NOTES. As part of this mission, the Joint Committee also created an organization called Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR). NOSCAR organized international meetings, developed and sought funding for a research agenda, fostered the translation of research findings into clinical trials, and began development of a human registry to track the clinical adoption of NOTES.
S. Schwaitzberg Department of Surgery, Cambridge Health Alliance, Cambridge, MA 02139, USA M. Kochman Internal Medicine, Department of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA L. Swanstrom Gastrointestinal and Minimally Invasive Surgery Division, The Oregon Clinic, Portland, OR 97210, USA D. W. Rattner (&) Department of Surgery, Massachusetts General Hospital, 15 Parkman Street, Boston, MA 02114, USA e-mail:
[email protected]
Summary of progress on issues outlined by the original White Paper NOSCAR continues to be the primary vehicle for addressing the issues laid out in the original White Paper (Table 1). By focusing research efforts on critical topics and by revisiting the issues frequently (primarily by peer review and at the annual meeting), substantial progress has been achieved in addressing many of the challenges inherent in natural orifice surgery.
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Table 1 Seminal ‘‘questions to be answered about NOTES’’ outlined by the 2006 NOSCAR White Paper
Infection
• Peritoneal access
Some of the harshest criticism of NOTES [5, 6] has been based on the incorrect assumption that transvisceral access for NOTES is equivalent to an iatrogenic perforation. Critics advance the argument that intraperitoneal contamination and infection are an inevitable consequence of NOTES, ultimately bringing harm to patients, a practice that ‘‘goes against the Hippocratic Oath’’ [5, 6]. Indeed, nearly all current surgical gastrointestinal procedures, including gastric bypass, expose the peritoneum to contamination. Subsequent animal and human studies have clearly shown that a controlled incision in the viscera is not equivalent to an iatrogenic perforation and intraperitoneal contamination and infection appears to be less of a problem than originally feared as long as the viscerotomy closure is secure [7, 8].
• Gastric closure • Prevention of infection • Suturing and anastomotic devices • Maintaining spatial orientation • Development of a multitasking platform • Management of intraperitoneal complications and hemorrhage • Physiologic untoward events caused by NOTES • Training
Peritoneal access In 2005, the investigators’ collective mindset was heavily influenced by the widely presented but unpublished case report from Reddy and Rao of a transgastric appendectomy. In addition, the pioneering animal work of the group from Johns Hopkins led many to think that NOTES would be a set of primarily transgastric procedures. It soon became clear, however, that the peritoneal cavity could be safely accessed via a variety of transluminal routes. Gynecologists quickly pointed out that they had been accessing pelvic organs transvaginally since the early twentieth century, and, in fact, Dr. Daniel Tsin had performed a transvaginal cholecystectomy before the White Paper was written [3]. At the present time, most human NOTES procedures have actually used transvaginal access because this route is well established for gynecologic operations on intraperitoneal structures and vaginal closure is easy to perform, safe, and secure. Transgastric access, however, remains an appealing approach because it is more universally available than transvaginal and often more appealing to patients. The ideal match-up between access, pathology, and patient preference has yet to be determined [4]. Gastric closure The Joint Committee originally identified gastric closure as a fundamental problem based on their initial frame of reference. There are now a variety of commercially available and in-development closure devices and techniques described. These technologies should make access and closure via the stomach or colon nearly as safe as the transvaginal route; the exact safety threshold required for public and practitioner acceptance has yet to be determined. Large-scale clinical studies will be needed to document a very low closure failure rate in comparison to standard techniques. An endoluminal method of determining closure security at the end of a transgastric or transrectal procedure remains an unresolved issue.
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Suturing and anastomotic devices Although frequently criticized for being slow to develop and market enabling devices for NOTES, industry has actually been quite productive in answering the challenges posed by the White Paper. Over a dozen purpose-built devices, including advanced clips, flexible iterations of laparoscopic suturing devices, and totally unique flexible closure systems have been developed and are in the process of approval. Unfortunately, only a small handful has made it through expensive and increasingly cumbersome regulatory pathways. Frustration on the part of practitioners wanting to use these devices is better directed at the cumbersome regulatory system and the downturn of the global economies than at the device companies. Spatial orientation and navigation Concerns about navigation and maintenance of spatial orientation appear to have subsided, particularly as practitioners have gained practical experience and have become accustomed to off-horizon visualization of target organs. There are still issues, however, particularly regarding selection of optimal positions for viscerotomy and safe visceral exit. It is also still felt that some sort of secondary imaging will be needed for higher-level NOTES procedures, from either image registration or secondary cameras, in order for the endoscopist to locate the exact intracavitary position of the endoscope. Development of a multitasking platform Several of the original eight fundamental problems were heavily dependent on device development. A robust flexible multitasking platform is currently still one of the
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rate-limiting steps; this too is nearly entirely dependent on industry partners. The first-generation platforms that have been FDA approved and used in humans to date are helpful, but more versatility is needed before universal application is possible. Promising prototypes of directdrive systems and multitasking flexible endoscopes are now being tested and hopefully will enable NOTES procedures to be performed more safely and rapidly, although their additional cost has become a major concern. For economic viability these advanced platforms will probably also need to facilitate endoluminal endoscopic procedures and perhaps single-site laparoscopy. Complication and hemorrhage management While there has been development of instruments to assist in hemostasis, such as bipolar forceps, there has not been a large push to address this problem partly because of the relatively low incidence of hemorrhage in over 2000 reported human cases. This may be due to the benefits of high magnification and precise dissection provided by intraperitoneal endoscopy. Of course, a secondary reason is the continued presence of a laparoscope to fall back on in most cases to date. While this provides a critical safety function at this point in NOTES evolution, flexible tools and strategies will need to be created as practitioners wean themselves off of laparoscopic support.
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practitioners has arrived as of yet. As more technology is developed and as safety in humans is documented, there will likely be an influx of NOTES practitioners from multiple disciplines. Meanwhile the ‘‘spinoffs’’ of NOTES, such as interventional endoscopy with NOTES tools or single-port laparoscopy, will maintain the interest of practitioners. Human case registry An additional charge from the original White Paper was to maintain a registry for all human NOTES cases. This has proven more difficult than originally imagined. The majority of the human NOTES cases have been performed outside the United States and have not been captured in the NOSCAR registry. Even for those cases performed in the U.S., voluntary reporting of data has been incomplete and NOSCAR has not had enough funding to assist in gathering or auditing the data. Despite these issues, NOSCAR has developed a database that is maintained on the SAGES website. To our knowledge, all human NOTES cases in the U.S. have been performed under IRB supervision, with generation of prospective data. If and when NOTES cases reach a critical mass and data are generated on a regular basis, the NOSCAR NOTES database can be activated to provide a robust data capture system.
NOSCAR mandates since 2005 Physiologic effects of NOTES There is a growing body of basic science knowledge generated by NOSCAR funding regarding the physiologic impact and possible benefits of natural orifice surgery. Thus far, no serious detrimental effects have been identified. Of course, the critical question for NOTES is whether it will be less painful and offer additional advantages in clinical cases. While there is some early indication that this might be true, there are no randomized prospective comparisons to answer this question.
NOSCAR initially focused on funding research to answer the basic challenges outlined in the original White Paper. As these were addressed, attention shifted to translating the laboratory work to human clinical trials. Achievements to date include: •
Training Issues regarding appropriate training and credentialing for NOTES are largely unresolved. Since NOTES routinely requires the addition of laparoscopy as a fallback or assist, human NOTES has largely become a surgical practice. While many centers continue to practice as a team—as was originally encouraged by NOSCAR—many, with more experience, have started practicing independent of their GI or GYN colleagues. There have been a handful of joint endoscopy/surgery postgraduate training programs proposed or initiated, but no cohort of dual-trained young
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NOSCAR has raised $2.85 million, resulting in the direct funding of 57 grants in a competitive peerreviewed manner. These grants have acted as seed funding and have been multiplied several times over by active research groups securing additional research monies from numerous sources, including industry, foundations, and federal grants. An example is a $2 million grant from the CIMIT (Center for Integration into Medicine of Innovative Technology) which has funded three NOSCAR member labs. To date, at least 36 peer-reviewed publications have resulted from this research funding. In addition, multiple presentations of funded research at recent national meetings will lead to publications over the next two years. NOSCAR developed the protocol and raised $1.35 million to fund the first prospective, multicenter, randomized human clinical trial of a NOTES procedure: NOTES
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cholecystectomy vs. laparoscopic cholecystectomy. This trial is currently accruing patients in six centers. Since 2005, NOSCAR has conducted five successful and productive international meetings. The ASGE/SAGES NOSCAR model of uniting national gastroenterology and surgical societies to create a group that will responsibly develop NOTES has been adopted around the world (EuroNOTES, Japan NOTES, Asia NOTES, South America NOTES, Canadian NOTES, and German NOTES). Following NOSCAR guidelines for human trials, human NOTES procedures, including cholecystectomy, appendectomy, splenectomy, and colectomy, are being performed under IRB protocols in a controlled and safe manner.
2010 International NOTES summit meeting On 7-9 July 2010, 105 invited experts from around the world who represent significant stakeholders in NOTES met in Chicago, IL. The 2010 NOSCAR meeting was designed as a working meeting for current practitioners/researchers in NOTES. Over the course of 2 days, a series of presentations, workshops, and breakout groups convened to review the current status of NOTES and to plot its future direction. The meeting started with a discussion and open forum on the NOSCAR-funded, multicenter, randomized NOTES cholecystectomy trial which was on the verge of opening to patient accrual and which has subsequently proceeded to enroll patients (http://clinicaltrials.gov/ct2/show/NCT011 71027?term=NOTES&rank=10). Drs. Steven Schwaitzberg and Michael Kochman reviewed the protocol in detail and received feedback from the audience. While the decision to power the study for equivalency rather than superiority was controversial, in the end the general consensus was that the study was a critical next step for the advancement of our understanding of NOTES. The NOSCAR trial therefore joins the many other ongoing clinical trials in the U.S., all of which were presented and discussed during the conference (Table 2). The second day of the conference began with an interactive session facilitated by Drs. Aaron Kaplan and Richard Rothstein from Dartmouth-Hitchcock Medical Center. This session involved both physician and nonphysician stakeholders and utilized role-playing exercises to highlight difficult regulatory and financial issues in the medical device development cycle. The importance of involving all stakeholders such as the FDA, device manufacturers, venture capitalists, insurers, hospitals, physicians, and patients in the process of developing NOTES cannot be overemphasized. Any progress in bringing NOTES from the lab to meaningful clinical use will need to address the concerns of all parties. The audience and participants had these points
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Surg Endosc (2011) 25:2441–2448 Table 2 Human clinical trials in the USA • Transanal NOTES sigmoid colectomy • Transgastric cholecystectomy • Transluminal endoscopic omental patch closure of perforated ulcers • NOTES appendectomy • Transgastric peritoneoscopy for staging malignancy • Transvaginal sleeve gastrectomy • Per-Oral endoscopic Heller myotomy Aside from the large randomized prospective clinical trial funded by NOSCAR comparing laparoscopic and NOTES cholecystectomy, there are multiple other nonrandomized human clinical trials underway in the USA. Many of these trials are multi-institutional
amply illustrated. As a direct result of this session, NOSCAR has established a direct link with third-party payers and the FDA that appears to have great potential for further proactive collaboration. Another session highlighted the global nature of NOTES work and included reports from leaders in the field from Japan, Europe, India, and South America. Each country presented a summary of their NOTES governance structure and where they were in NOTES development and application. While many countries were at the same level or behind the U.S., there are others that have far greater experience. The largest experience with NOTES procedures is from Germany where well over 1500 transvaginal cholecystectomies have been performed. Recently, a report on 551 cases of natural orifice transluminal endoscopic surgery from the German NOTES registry was published in Annals of Surgery [9]. South America also reports a large and diverse experience with transvaginal cholecystectomy, in particular, approaching a clinical norm in several centers. There was much discussion regarding the differences in acceptance and practice of NOTES from country to country. The majority of the meeting was devoted to working group sessions in which all attendees participated. Working groups focused on both procedure development and targeted technology assessment and included multiple small breakout sessions (Table 3). The report of each of these groups was then presented to the meeting and audience input was obtained. The conclusions of each of these working group sessions amounts to a powerful consensus statement regarding the current and future status of NOTES and the proceedings of these sessions will be published separately. Other sessions covered the ‘‘trickle-down effect’’ realized in the course of NOTES development. The term, borrowed from economics, describes the dissemination of technologies and approaches developed with NOTES in mind to practices such as endoluminal therapies and laparoscopic surgery. Current NOTES devices for closure,
Surg Endosc (2011) 25:2441–2448 Table 3 Working groups at the 2010 NOSCAR meeting Procedure development • Transvaginal chole • Transgastric chole • Colorectal • Solid organ • Transesophageal/thoracic • Endoluminal • Single port Targeted technology assessment • Advanced platforms • Imaging and optics • Robotics
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Summary and the future of NOTES It should be stressed that NOSCAR is not an independent society but rather the representative of the major medical societies representing interventional endoscopy: SAGES and ASGE. The major charges of the Joint Committee of NOSCAR are to assess the potentials of NOTES, to facilitate research on NOTES, to insure the protection of patients during the implementation of NOTES, and to report on current developments in this evolving and dynamic field. The reason for the current publication is to satisfy these mandates. Based on our experience, we perceive the following trends and issues in the field of NOTES:
• Basic tools • Closure devices
resection, retraction, and hemostasis are having a great impact on the practice of interventional endoscopy, by both providing gastroenterologists with new tools and stimulating surgeons to consider the flexible endoscope as a surgical tool. Perhaps the major take-home message from the meeting was that NOTES is at a phase where feasibility has been proven, but that the full potential of NOTES has yet to be realized or even fully contemplated. A tremendous amount has been accomplished to advance NOTES since the first poster presentation by Kantsevoy and Kalloo in 2002 and the creation of NOSCAR in 2005. A large body of targeted basic research has answered the feasibility and basic safety questions posed by the 2006 White Paper. This research has produced a fund of knowledge to serve as the foundation for careful and measured clinical translation to human trials, which is happening today. While the primary goal of the collaboration between SAGES and ASGE was to responsibly develop natural orifice surgery, there have been other effects of NOTES that will dramatically impact flexible endoscopy as well as laparoscopic surgery. The work of NOSCAR has brought together two major societies from different disciplines—thought to be leaders in laparoscopic surgery and flexible endoscopy—who together have enough influence to impact the direction of industry investment and perhaps regulatory and reimbursement issues. This network of relationships, created in the efforts to develop technologies for NOTES, has resulted in a very significant ‘‘trickle-down effect’’ for both interventional endoscopy and laparoscopic surgery. Further device development in parallel with well-conducted clinical trials is needed to move the field forward. Finally, this group felt strongly that it was appropriate to issue an official progress report of the work to date and plans for the future.
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Administrative roadblocks in NOTES implementation Spinoffs such as single-port laparoscopy and interventional endoscopy Human applications and progress
Roadblocks to further adoption There is a strong perception among those involved in NOTES development that the technical obstacles will be relatively straightforward to overcome. It would then be left primarily to human trial results and public preference to determine if and in what circumstances NOTES is more desirable than current standard surgical approaches. Most would agree that currently the most difficult obstacles actually lie in the regulatory and reimbursement arenas. Much of the innovative and enabling technology for NOTES comes from small startup companies whose structure and financing cannot withstand years of regulatory and reimbursement challenges. There seems to be a trend in the U.S. and worldwide toward increasingly arduous regulation of the medical device industry. These regulations are defended as patient safety and cost-savings efforts, but carried to illogical extremes they stand to deny access by patients to less invasive care. In the past, the American health-care system was able and willing to absorb some or most of the costs of technology development. This was certainly the case with laparoscopic cholecystectomy, when initial cases were more expensive than open surgery due to longer OR times and increased equipment costs. Another recent example is the proliferation of robotic surgery for which reimbursement remained fixed in spite of huge increases in cost but for no documented patient benefit other than consumer preference. In the current economic climate, it is apparent that NOTES will be held to a higher standard by insurers and government payers and be accepted only if it is proven to lower overall costs, a difficult standard for any new, developing technique, but
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one that nonetheless will need to be addressed by individuals and groups like NOSCAR. In addition, the regulatory environment has changed greatly. In the past, many devices could be placed in the hands of physicians through the FDA 510 K approval process. Physicians have traditionally been allowed to use FDA-approved devices in ways that they were not specifically approved for (i.e., ‘‘off label’’ use). This approach is being challenged now and increasingly new devices are being forced through the longer, more expensive premarket approval application (PMA) process. This will at best delay and at worst prevent many enabling devices from being developed and placed in the hands of innovative physicians. Even if a device or procedure makes it through the federal regulatory cycle, it must face the increasingly hostile and demanding battles of the current procedural terminology (CPT) coding process, third-party-payer approvals, and hospital credentialing and purchasing processes. NOSCAR strongly encourages proactively addressing these issues now by establishing dialogs with involved parties in order to keep the investigation of NOTES approaches viable. Perhaps the most important force in determining the future of NOTES will be patient demand. With health-care reform, it is likely that patients will exert greater control over the delivery of health care. The reaction of patients to NOTES procedures cannot be determined without large-scale human trials and these are just now beginning. However, if NOTES techniques are shown to less invasive, cosmetically more acceptable, and carry acceptable costs, then there is no doubt that the current surgical paradigms will change. NOTES spinoffs It is increasingly apparent that an important aspect of the introduction of NOTES is its endoscopic and laparoscopic ‘‘spinoffs.’’ The ability to apply NOTES technologies to laparoscopic or endoscopic procedures makes it economically feasible for industry to invest in the development and introduction of these new instruments. It also gives current practitioners the ability to utilize ‘‘NOTES’’ techniques/ technologies in their practice today, marking time while the best procedures and tools for true incisionless procedures are slowly being worked out. There are many examples of NOTES influencing the thought process in therapeutic endoscopy. In the past, an iatrogenic perforation was an absolute indication for surgical intervention. With collaboration of ideas between surgeons and gastroenterologists and the development of closure devices, many esophageal, gastric, and colonic perforations can now be successfully managed at the time they occur with clips, sutures, and stents. Endoluminal techniques for the management of obesity have also paralleled the development of NOTES as well as the endoscopic management of
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complications of obesity surgery such as leaks, fistula, and stoma and pouch reduction. Finally, the concept of an endoluminal approach to full-thickness intestinal resection will soon come to fruition, initially with laparoscopic control, but eventually resection and closure will be accomplished completely from an endoluminal approach. One of the theoretical advantages of NOTES is that it produces no visible scars. However, the instrumentation that can be delivered via flexible transluminal access to meet many of the key needs of surgery is not available at the present time. In addition, the transition from traditional laparoscopic surgery to pure NOTES represents a quantum leap for many surgeons. The idea of single-port laparoscopic surgery was born from this dilemma. Desai et al. [10] conceived of performing surgery through a single umbilical port using modified laparoscopic instruments and new, multichannel laparoscopic ports. In an attempt to align singleaccess-site surgery with NOTES, some even claimed the umbilicus as a ‘‘natural orifice.’’ The umbilical incision was hidden and therefore met the no-scar or at least the no-visible-incision criterion. Nonetheless, this approach is still essentially laparoscopic surgery and not what the Joint Committee had envisioned when the term NOTES was coined. In spite of this dichotomy, several of the challenges created by using a single site of access to the peritoneal cavity are identical to those that need to be overcome for NOTES to progress. Lessons learned in creating triangulation in singleaccess-site surgery will likely be translated to the NOTES environment. Single-port surgery developed as a result of some of the near-term challenges for NOTES and likely represents a point on the continuum of techniques beginning with therapeutic flexible endoscopy and standard laparoscopic surgery and ending with pure NOTES. The rapid adoption of spinoffs such as single-port laparoscopy further validates a move toward reducing the size of surgical access, and single-port surgery will provide a clinically applicable testing ground for some issues surrounding NOTES, especially the issues of multiple instruments working in parallel. In the meantime, the trickle-down effect of NOTES on intraluminal therapies will advance the discipline of interventional flexible endoscopy and provide opportunities for gastroenterologists and surgeons to develop skills, techniques, and devices that will have eventual application in NOTES and provide improvements in patient care today. Human applications A frustrating aspect of NOTES has been an inability to define the optimal human procedure for its first widespread application. Cholecystectomy is the most widely performed NOTES procedure to date—mostly due to its ubiquity, its history as an initial target for minimally invasive surgery,
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its representation of all elements of surgery, and the fact that laparoscopy is a ready fallback. However, it is widely felt that removing the gallbladder is not the ideal target for widespread NOTES adoption. This is due to the already minimally invasive nature of the laparoscopic gold standard. There is consensus, however, that cholecystectomy is a worthwhile model for the initial exploration of the potential of NOTES. As this remains one of the most critical questions in NOTES, much time was spent discussing the future best applications of NOTES approaches at the 2010 NOSCAR summit. Top contenders for the ideal human application include: •
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Transanal/vaginal colorectal surgery: Transanal endoscopic microsurgery (TEM) was first introduced by Gerhard Buess in 1984 [11]. The adoption of this technique has been slow, but with the advent of NOTES there has been a surge in interest. The TEM device (Richard Wolf Medical, Vernon Hills, IL) provides many of the answers for the platform requirements of transanal surgery. NOTES investigators are now using the transanal approach with the TEM platform to investigate transanal NOTES for sigmoid resection [12, 13]. There are several appealing aspects of a NOTES approach to colorectal surgery, including the ability to retrieve large specimens, immediate access to the dissection plane, avoidance of the need to perforate a noninvolved organ, and definite patient advantage by avoiding multiple large port sites and a large specimen retrieval incision. Colotomy closure is also able to be performed in a validated direct fashion. One of the most exciting examples is endoluminal myotomy for achalasia. The technique was first reported by Pasricha as a spinoff of work with the Apollo Group to advance NOTES and endoluminal therapies [14]. The technique was further refined by Inoue, who has now performed more than 50 human cases of peroral endoscopic myotomy (POEM). The preliminary results look very promising, though studies comparing it to laparoscopic Heller myotomy are now needed [15]. Staging peritoneoscopy for GI malignancies was also widely discussed and was felt to be a procedure that might provide great benefit to patients but also be practicable with current technologies [16]. It was also felt that this might be a procedure readily adapted to the practices of gastroenterologists as well as surgeons.
Conclusion For those skeptics who dismissed NOTES as a passing fad, the evidence to date suggests that this notion is wrong.
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NOTES is increasingly well established as a concept and methodology. Rather than being an end point in and of itself, NOTES is a way of thinking that regards the use of a natural orifice in conjunction with flexible instruments as a less invasive and more cosmetically appealing method of performing certain surgical procedures. The time line to widespread clinical adoption of NOTES and the ideal entry procedure is unknown and not critically important. The important thing is to properly develop NOTES procedures, assess them critically, and take advantage of the ideas and techniques that spin off along the NOTES developmental pathway. Disclosures David Rattner is a consultant for Olympus Corporation. Robert Hawes is a consultant for Olympus Corporation and Boston Scientific Company; has received honorarium for lecturing from Cook Endoscopy; and has an equity position with Apollo Endosurgery. Steven Schwaitzberg is on the Advisory Committees of Acuity Bio, Cambridge Endo, MITI, Neatstitch, Stryker, and Surgiquest; and is a consultant for Endocore, MMDI, and Olympus. Lee Swanstrom is on the Advisory Panel of and gives research support to Boston Scientific Company, gives research support to Olympus Corporation; and is on the Advisory Panels of USGI and Virtual Port. Michael Kochman has no conflicts of interest or financial ties to disclose.
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