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As Published in: Elsevier Business Intelligence MAY 2009 www.ElsevierBI.com Vol. 27, No. 5 Medical Devices Medical Devices/Surgical Biopharma Drug Development Medical Devices Health Care TransEnterix: In HCV, Protease Race Changing Minds Reforms Target Managing Heats Up with Combo at the FDA on Medical Devices Revolutions in Therapy Looming Devices DAVID FILMORE Surgery CHRISTOPHER MORRISON TOM SALEMI AND STEPHEN LEVIN DAVID CASSAK AND JOSEPH HAAS Actelion Follows Innovation Into GP Markets Switzerland’s Actelion has become Europe’s most successful biotech in large part thanks to PAH treatment Tracleer. It’s now preparing a move into primary care just as many of its larger counterparts begin to exit. MELANIE SENIOR Transforming Pharma’s Commercial Capabilities/Developing Molecular Imaging Agents MEDICAL DEVICES/SURGICAL TRANSENTERIX: MANAGING REVOLUTIONS IN SURGERY Whether single-port surgery or NOTES is the true next revolution in surgical procedures, TransEnterix believes it has the answer to both. BY DAVID CASSAK ■ Minimally invasive sur- gery, performed through a number of ports to cre- or all of the change that minimally in- ent ports—with one single access port; the ate access and enable vi- vasive approaches brought to surgery other NOTES, surgery performed through sualization, manipulation, Ftwo decades ago, the MIS (minimally- natural orifi ces of the body, requires no and dissection, promised invasive surgery) revolution has fallen some- surgically created ports at all. to revolutionize surgical thing short of complete. While conversion Both single-port surgery (SPS) and NOTES techniques two decades to MIS or laparoscopic techniques was would enhance many of the benefi ts of ago, but ultimately fell rapid and remains at nearly 100% in gall multi-port surgery such as reduced pain and short of changing the way surgeons perform the ma- bladder removal (cholecystectomy), other trauma for the patient and quicker recovery jority of surgical cases. procedures have taken longer to convert times. But neither is without its skeptics: and have come nowhere near the same single-port surgery critics argue that the ■ Part of the problem: sur- rate of penetration—thus procedures such benefi ts of such an approach are little more geons were uncomfort- able with the devices as bowel resection and appendectomy are than cosmetic, while even NOTES advocates developed to enable only performed laparoscopically about 50% concede that the current buzz is based on more complex proce- of the time; in an area like cardiac surgery, little real clinical evidence. dures. TransEnterix’s so- penetration rates have stalled at much lower To most people’s minds, single-port sur- lution: surgical tools that numbers. gery is the nearer-term prospect, but NOTES adapt the fl exible cath- A large part of the pushback came be- is the true revolution, with single-port simply eter technology behind cause surgeons found that more complex a way station until the clinical bona fi des of interventional cardiology procedures were diffi cult to do with the NOTES are clearly established. But for some to general surgery. rigid instrumentation that was perfect for time at least, the two will be competitive: if ■ TransEnterix’s novel ap- lapaproscopic cholecystectomy. There were you have a really effective single-port tech- proach not only allows two solutions for solving the problem of nique, why bother with NOTES? Neither, surgeons greater dexter- MIS’ lax penetration beyond lap choly: im- however, is likely to represent anything like a ity in performing com- prove the instrumentation and/or improve real fulfi llment of the MIS revolution without plex procedures, but also the surgical techniques. one more thing: an agile technology that en- enables them to do surgi- For much of the late 1990s and early ables either or both new surgical approaches cal cases through a single access port, using the 2000s, no one did much of either. In- to be performed. NC-based TransEnterix body’s umbilicus. novation in surgical instrumentation and Inc. believes it has just such a technology, devices, in particular, lagged, with few, if created through the marriage of MIS tools ■ So-called single-port any, breakthrough technologies beyond a and the fl exible catheter technology of in- surgery has its skeptics, but it’s gaining momen- robotics industry that grew by fi ts and starts. terventional cardiology. tum. The question for But beginning a few years ago, surgeons TransEnterix: how will themselves began to experiment with new A CARDIOLOGIST’S TRICKS single-port surgery play ways of doing minimally invasive surgery When Richard Stack’s mother and brother out against the surgery’s that would build on and improve conven- each had laparoscopic surgery a couple of newest technique—nat- tional MIS techniques. One new approach years ago, it was clear that the surgery was ural orifi ce transluminal centered on so-called single-port surgery: anything but minimally invasive. Yes, the endoscopic surgery, or replacing the multiple trocar-created surgery was performed through a series of NOTES? access points through which surgery is ports, enabling access and visualization and done—sometimes as many as fi ve differ- the procedure itself, rather than through 1 | May 2009 | IN VIVO: THE BUSINESS & MEDICINE REPORT | www.ElsevierBI.com MEDICAL DEVICES/SURGICAL large, open incisions. And yes, Stack’s relatives saw some of the SEVEN STEPS purported benefi ts of minimally-invasive surgery: reduced pain TransEnterix was offi cially launched at the end of Decem- and trauma for the patient, easier technique forthe surgery. But by ber 2007, but Synecor offi cials had already done a signifi cant the time the surgery was done, those benefi ts seemed dminished amount of work on the company’s technology before the offi cial by the multi-port strategy, and Stack began to wonder if there launch, creating what CEO Todd Pope calls “a single-port access wasn’t a better way to do surgery. platform in surgery.” The platform combines both a proprietary Soon after those procedures, Stack, a physician and pioneer in access approach and a wide range of instruments—some still interventional cardiology and founder of Synecor LLC, a North to be developed—that enable a variety of surgical procedures, Carolina-based incubator with an impressive track record in device- some of which will be proprietary to TransEnterix, some not. It is company creation, approached Aurora Pryor, MD, the surgeon this comprehensive approach in terms of both clinical reach and who had performed the surgeries, to talk about what seemed like procedural capability that makes the technology a platform, say a relatively invasive approach to less-invasive surgery. Stack had company offi cials. already begun to hear about a surgical approach called NOTES Interestingly, Synecor offi cials didn’t start out trying to develop (natural orifi ce transluminal endoscopic surgery), a procedure by a single-port system; rather, blending perspectives from both inter- which surgeons cross the lumen (abdominal wall, colon, esopha- ventional medicine and current surgical approaches, the idea was gus, etc.) to perform surgery in the peritoneal cavity, thorax, etc., simply to create better tools for use in minimally invasive surgery accessing the surgical space through one of the body’s natural to, as Todd Pope puts it, “enhance the laparoscopic experience.” openings. “That just seemed like something that could easily be In fact, some of the instruments TransEnterix has developed have done through a catheter,” he recalls. Within a couple of years, never been used in general surgery before. Stack and Pryor would launch TransEnterix, a North Carolina- That said, TransEnterix has tried, as far as possible, to replicate a based surgical device company with a platform technology that traditional laparoscopic procedure, but with the benefi t of single- company offi cials believe will put it in the vanguard of a second port access. For example, company offi cials note that early market revolution, after MIS itself, that is coming to surgery. research showed that surgeons like the traditional triangulation From the beginning, Stack had been intrigued by the possibility of visualization and manipulation, with the camera in the middle of using fl exible catheters in surgery—interventional cardiology, and various instruments coming to the (closed) operation site after all, rests on innovative ways to deploy catheters—and work- from the sides. ing with Aurora Pryor, who now serves on TransEnterix’s SAB, he In addition, surgeons want to be able to use as many of the began to develop a series of surgical tools that would combine the tools they currently use as possible—graspers, clip appliers, dis- fl exible catheters of interventional medicine with access through sectors, etc.—and they like to be able to retract organs, such as a single port, rather than the multi-port approach currently used gall bladders, without exchanging instruments: TransEnterix’s in MIS. “It was pretty clear that we could use the same catheter four-channel system allows surgeons to do just that, whereas most technology [that had been used in interventional cardiology] other single-port approaches today, which have only two or three but instead of making four or fi ve penetrations of the abdomen channels, don’t. “We don’t want to have to ask surgeons to do wall, we’d just go in through the umbilicus, which is already a anything differently,” says Pope. natural scar,” he says. “We thought we’d put everything through a catheter and get the same kind of orientation we’d get if we’d A REVOLUTION CUT SHORT penetrated the wall, but with no holes.” Better, more fl exible instrumentation would likely also make more Indeed, Stack insists that far from a departure from Synecor’s complex MIS procedures faster—slow, diffi cult-to-perform cases core interventional cardiology expertise, TransEnterix is, in some are a major reason MIS penetration beyond lap choly has lagged.

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