Rhodel Dacanay, NEVENT - Safety Sheath for Retained Guidewires | LSI USA '24

Rhodel Dacanay  0:02  
I'm here to talk about this. This is a test X ray showing a retained guide wire, a clear indication that a medical error has occurred. We have the only patented solution for preventing the retention of these guide wires, along with their associated costs and complications. I'll talk about the market which is large and growing. I'll talk about the problem which is widespread, involves serious morbidity and even mortality. The solution, which is proprietary, is the only effective solution and is intuitive to use. Additionally, it's simple and inexpensive to manufacture, will yield a high margin and the ability to capture market share. The market is large and growing currently, $1.28 billion market in North America for central catheters projected to grow to 1.8 billion by 2030 the global market is about three times that, and it's a big problem. It actually affects over 1500 patients every year, and based on a Harvard Foundation study, it's costing hospitals and physicians about $830 million of additional cost every year. It's so significant that in 2018 The Joint Commission declared retained guide wires a never event. Now what does that declaration mean? It means that, by necessity, any solution will be eligible for FDA fast tracking. It imposes an additional fine per incident, and importantly, it extends the culpability beyond just the operator to now also include the hospitals and hospital systems in which they occur. As a little background, Dr Sven zeldinger developed this technique about 70 years ago of basically advancing a catheter over a flexible guide wire and into a blood vessel. The common denominator where this error occurs is a misstep when the catheter is advanced over the guide wire. This video, I'm going to demonstrate how this occurs clinically, as in the diagram, the first step of the celldinger technique involves advancing a needle while aspirating on a syringe until I get the return of blood indicating the proper placement of the needle tip within a vessel, at which point I remove the syringe and advance a guide wire through the needle and into the vessel. The needle is then removed, leaving a guide wire in place. Now a catheter is advanced over the guide wire and into the patient. The misstep occurs because the guide wire does not protrude through the proximal end of the catheter before it is advanced into the vessel. The reasons that this occur in each instance are multifactorial, and I will allude to some of those reasons in the presentation. So that was the how this error occurs, the why, though, is much more complicated. These large catheters are usually placed when the time is critical. The patients are unstable. We need to infuse fluids and blood rapidly. The setting is crowded and busy. The whole time, the same physician has to maintain that patient's vital signs, including their blood pressure and oxygenation, and if there's a perturbation, they have to administer rapid acting medications, all the while wearing personal protective equipment and maintaining a sterile field. Yes, it's an operator error. It's an operator problem, but it needed a system solution. I'm Rodel dakini. I'm in my 17th year of private practice as an anesthesiologist at an inner city level one trauma center. Before that, I was an academic anesthesiologist. I have an engineering background and am represented by Venables legal team. The solution is a removable internal safety sheath. It will have integrated features that will prevent the unwanted migration of guide wires into a patient's body. Simple, elegant. The US Patent and Trademark Office agreed that it was novel, functional and non obvious. Those things will be borne out a little bit better. This video clip, I will demonstrate the only effective method of preventing the migration and inadvertent retention of a guidewire into a patient. The steps are the same as originally described by Dr Seldinger an illustrated diagram, the lumen of the vessel is excess with a seeker, or thin walled needle, and proper placement is confirmed by the return of blood into this range. A guide wire is then inserted through the needle, and the needle is removed. This leaves a guide wire. Within the vessel now with a removable safety sheath within the catheter, even minimum insertion of the guide wire into the sheath. Please note that there is no guide wire protruding through the proximal portion of the catheter if at this point the misstep occurs and everything is advanced into the patient, the guide wire will not be lost. The misstep is identified, and in fact, it has to be identified because there's no way to attach a syringe or fluid administration tubing to the catheter while the safety device is in place. At this point, the misstep is identified and the safety device is removed, and the guide wire will be attached to it. So despite a misstep, the guide wire is removed along with the safety sheath, and the remaining catheter is completely intact and usable. The safety device is not obtrusive. It can come preloaded in the catheter. It is intuitive, because it must be removed before the catheter can be used, and it's exactly the same step as we would always carry out in the celling or technique of removing the guide wire, the safety device and the guide wire are simply removed in the same step. So that's on the clinical side, and the cost to our patients is clear and oftentimes very large, has about a 5% mortality rate when it occurs and a 10% serious morbidity rate. On the other side, we place about 5 million of these every year. In the United States alone, 90% of these had gone unreported because it's a clear error in on the physician side, however, vanucci EAL did a large retrospective study and determined the actual incidence is about one in every 30 250 placements. So it affects about 15 140 patients every year. The Harvard Foundation did a large study to determine the cost for the hospitals and physicians for retained foreign bodies, including retained guide wires, their average cost was $473,000 per incident, if serious morbidity or mortality occurs. That average goes to $2 million the JCO fine. That's now added to that is averages $60,000 per incident. It adds up to a large number, about $830 million of extra cost to physicians and hospitals that are just kind of a hidden cost of doing business, or per catheter, about $166 so if you spread that over all the stakeholders at a conservative markup of $75 a catheter company would yield $375 million in additional revenue, while still saving hospitals and physicians almost half a billion dollars every year. Vice specialty is a prime example that patience is not always a virtue. This is a much needed safety device, and it's not for the patient, investor or company. It is by necessity, eligible for FDA fast tracking. It is by design, straightforward and inexpensive to manufacture. It is by demand, logical to market. The future will be the progressive company that seizes the opportunity to capture this $1.28 billion market while adding 370, $5 million of revenue, realizing significant R and D savings, because we all have these think tanks that are paid and rarely produce, I think, something that will benefit patients as much as this. The whole time you're saving hospital systems and physicians an extra $455 million a year, and those are 20 $13 Thank you. Applause.