The Role of Sealants and Glues in Surgery

The terms “sealant” and “glue” tend to be used interchangeably in the surgical context, but in fact there is a difference in adhesive strength between sealants, pioneered by fibrin products (sometimes homemade) and the later, stronger glues of which cyanoacrylate-based products were the leaders.

Fibrin sealants represented a revolution in local hemostatic measures for both bleeding and non bleeding disorders. Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for hundreds of years. Fibrin sealant has the potential to provide life-saving control of excessive bleeding in many critical surgical operations and during a number of elective procedures. It is used for local hemostasis and as an augmenting material during arterial bleeding. It has been applied to every organ except eyeballs. It has been shown to be very useful for local hemostasis, a valuable tool for adhesion, sealing, anastomosis, vascular and nerve grafts, and many other procedures

Fibrin and other sealant products have been approved and used outside the USA for many years and their use has created strong awareness of their surgical and economic benefits in Europe, Latin America and Asia. As a result, many products that have been on sale in these regions for up to twenty years and have been developed for a variety of surgical uses. In the USA, these products are approved mainly as hemostatic adjuncts to suturing; elsewhere they are used much more extensively as sealants and low-strength glues, as well as for their hemostatic properties. Listed below are some applications found in a recent survey of surgical procedures around the world. We believe that this represents an untapped market opportunity within the US market for these products.

More than 25 million surgical procedures are performed in the, USA each year, and proper closure of all wounds is vital to achieve efficient healing. Sutures and staples are the most common methods of closure, but often they are sub-optimal. They do not have inherent sealing capabilities, and therefore cannot stop air and fluid leakage (for example in lung resection) and fluid leakage at the wound site. Furthermore, friable tissues such as the liver, brain or spleen, are fragile and often cannot support sutures or staples. Therefore, other means of wound closure are required for repair of these tissues.

As of today, several hemostatic agents, including fibrin and other sealants, provide hemostasis and sealant capabilities by complementing and accelerating the body’s natural blood clotting processes. The adhesive strength of fibrin and other sealant products is often considered to be insufficient to close wet tissues on their own, and the hemostatic characteristics of these products are sometimes viewed as inadequate for actively bleeding tissues. For these reasons, these products have been considered as adjuncts for many closure applications; in the USA, the FDA has approved products as adjunctive for hemostasis and closure of surgical incisions. As examples, the FDA approved a number of surgical sealants including RapidSeal Patch introduced by Fusion Medical Technologies, the Tisseel product sold by Baxter, and Haemaseel fibrin sealant distributed by Haemacure. The RapidSeal Patch was approved for the indication of sealing air leaks in lung surgery, and Hemaseel and Tisseel were approved for cardiovascular and severe splenic injuries. We believe that there is justification for these products to be considered by surgeons as vital adjuncts for specific surgical indications where tissues are friable, where there is a risk of continued leakage of fluid or gas, and where hemostasis is important to the outcome of the procedure.

The exhibit below illustrates the major surgical applications of fibrin and other sealants.

 

Applications of Fibrin and Other Sealants

  • Local hemostatic measures for both surgical and trauma cases
  • Surgery in patients with bleeding disorders (e.g. hemophilia, severe thrombocytopenia) and non-bleeding cases with suspected fluid oozing
  • Surgery in nonsuturable organs (e.g. brain, liver, lung, pancreas, thymus) or to repair unhealthy tissue (e.g. irradiated bowel or tissue of elderly patients)
  • Cardiovascular, microvascular surgery and vascular grafts (e.g., aneurysm repair, coronary bypass, etc)
  • Nerve grafts
  • Skin grafts, particularly plastic surgery
  • Surgery of small or difficult to reach organs (e.g. tympanoplasty, ENT, eye)
  • Sealing of body cavities, fistulae, pneumothorax, cranium, etc
  • Anastomosis of gastrointestinal, tract and other ductal organs

Source: MedMarket Diligence, LLC

As an example, in trauma, uncontrollable bleeding and complications associated with the requirement for massive blood transfusion account for the majority of deaths in patients requiring surgery for intra-abdominal hemorrhage. Approximately 15 percent of trauma patient admissions involve intra-abdominal hemorrhagic injuries. Unfortunately, high rates of failure and mortality are seen with existing surgical procedures, which are based on the use of quantities of gauze for blood absorption, and application of localized pressure to treat hemorrhagic injuries such as these. This unsophisticated technique has the further disadvantage of the need for further intervention after a few days to remove the gauze. Fibrin and other sealants offer improved success rates for these operations.

In addition to controlling bleeding during trauma surgery, cardiovascular bypass, angioplasty, cranial and spinal sealing, total knee and hip replacement procedures, pneumostasis during lung surgery, and liver and spleen surgical operations are the most immediate untapped opportunities for sealant products in the USA. Research into current practice outside the USA has revealed that fibrin and other sealants have a role in many types of surgical procedures (see report #S145).

(From “Worldwide Surgical Sealants, Glues & Wound Closure, 2007,” report #S145, published February 2007.  Copyright 2007, MedMarket Diligence, LLC.)

 

Tags: medtech, glues, sealants, fibrin

Energy-Based Devices in General Surgery


The dynamic market for energy-based devices used in general surgery is growing steadily with compounded annual growth rates of 12% projected for the short term. This market includes devices based on ultrasonic, radio frequency (RF), light, thermal, hydromechanical, cryogenic and microwave technologies.

The popularity of ultrasonic devices is due in large part to the fact that they do not utilize heat when sealing tissues, thus effectively eliminating smoke from the operating room. This can reduce costs for hospitals as the absence of smoke eliminates the need for smoke evacuation systems. Meanwhile, the lack of smoke also improves the surgeon’s line of vision. Also to their benefit, ultrasonic surgical instruments combine cutting, grasping and coagulation into one tool set, thus further reducing cost while also reducing surgical time as there is no longer a need for intraoperative instrument exchanges. Lastly, patient safety is enhanced because with ultrasonic systems, there is no electric current passing though the patient’s body, which can result in lateral tissue damage.

The second largest segment in the market for energy-based devices used in general surgery comprises devices based on RF energy, which (like laser systems) rely on thermal welding to achieve tissue coagulation. RF devices comprise roughly 27% of the overall market for devices used in general surgery. Growth in this market segment is being driven by the introduction of new technologies into the marketplace.

Thermal energies, which are used most often in surgeries to treat benign prostatic hyperplasia (BPH) and menorrhagia, also have application in general surgery, however, less than 5% of the market is devoted to these systems. Newly developed hydromechanical (based on water-jet technology), cryogenic, and microwave systems also are being introduced into the market, thus further fueling market growth in devices designed for general surgery.

Many developments have occurred among the manufacturers in this dynamic market over the last several months.(Further details in August 2006 MedMarkets.)

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August 2006 startup medtech companies

These are the startup companies we identified and have published in the August 2006 issue of MedMarkets.

Artisan Therapeutics, Inc. — Framingham, MA; no URL
Andrew Tehnologies, Inc. — Haddonfield, NJ; http://andewtechnologies.com [under contruction]
Nitric BioTherapeutics, Inc. — Brisol, PA; no URl
Recovery Science, LLC — Hollywood, MD; no URL
SurgiQuest, Inc. — Fairfield, CT; no URL

Source: MedMarkets, August 2006, MedMarket Diligence, LLC

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Local Market Volume of Medical/Surgical Procedures

I continue my discussion of our use of the Medicare 100% file and other datasets to serve specific needs of medical product manufacturers.As I mentioned, the Medicare 100% file is large (measured in gigabytes) unwieldy and, as anyone who has purchased raw data from the U.S. government can attest, the file is not constructed in the most convenient format to allow simply queries, summaries or other processes that will reveal meaninful insights. And, given the cost, the need for HIPAA-related disclosure agreements to be signed,m the dataset is not quite amenable to data analyst with occasional interest or need in purusing it. Lastly — and this goes for all reimbursement or discharge survey datasets — whatever logic may govern the coding systems (DRG, ICD-9 and CPT4) used in this data, the reality of how clinicians fle claims and how survey data is collected can result requires that working with claims-based and survey-based datasets be done by someone with experience in these issues.

Now you might understand why the question, “So if this is in the public domain, how is your product in any way unique?” causes me to take a breath before answering.

MMD has joined with Medical Technology Partners (MTP) to capitalize on MTP’s use of these large datasets, which have been acquired for reimbursement consulting, to use them for answerng very technology-specific and facility-specific questions raised by medical product manufacturers.

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Megatrends in Medical Technology

(June 2006 MedMarket Outlook in MedMarkets)

Megatrends in Medical Technology
Aside from other trends in the medical product industry we’ve addressed previously in MedMarket Outlook, such as the dissolution of boundaries between device and pharmaceutical technologies, the increasing integration of information and information technologies with medtech, and the rise of “holistic research” (aka “systems biology”) that recognizes the value of studying pathology with a multidisciplinary scientific approach, there are specific overarching trends and forces that are changing medical technology and the markets for them on a grand scale.

Stem Cell Research
The debate about stem cell research was no more likely to end as a result of President Bush’s restriction on federal funding as it was that the established cell lines would be sufficient or appropriate for research (they weren’t) or that the case would abate (as they have not) for the use of stem cells in the treatment of diabetes, Parkinson’s, spinal cord injury or other disease and disorders. Here, we make no ethical case for or against embryonic or somatic stem cell research — the debate is likely to become wholly moot in a matter of time — we only comment on the inevitability of the science moving forward one way or another. In June, Harvard University’s Harvard Stem Cell Institute confirmed that two projects focused on cloning to produce embryonic stem cells will move forward under private funding. The projects employ the same general type of research, somatic cell nuclear transfer, that is underway at the University of California at San Francisco and at the University of Connecticut’s Center for Regenerative Biology. Aside from these approaches, a cursory review of the state of cell research in general and stem cell research in particular will reveal that researchers have both the innovation and the willingness to pursue cell therapeutics that lead to treatments heretofore not possible. It seems fairly certain that, looking back at progress in the development of the range of cell therapies, the Bush administration’s federal funding restriction will be seen to have produced a momentary hitch rather than the obstacle it was originally portrayed as producing.

Nano- and Microscale Juggernaut Forces
There are as many different functions — maybe even more — being provided by technologies designed around nanoscale or microscale level as there are different types of these technologies. The sole criteria for technologies grouped into the nano and micro categories is size. Aside from their size, there is then little common among these technologies, which represent an incredible array of devices, molecules, materials and other products that achieve functions not possible on the macro scale, even if one only considers nano- and microscale medical applications. These range from products that are largely nanoscale materials (e.g., silver nanoparticles as antimicrobials in wound management) to those providing functions such as artificial retinas, cancer diagnostics, drug delivery and biosensors. As an industry, nanotechnology (more so than MEMS, which has found considerable realized success) has been plagued by a combination of inflated promise and underestimated technical hurdles, but while MEMS (microelectromechanical systems) has found bigger initial commercial success, nanotechnology has begun scoring commercial success that will ultimately result in markets that will eclipse MEMS products by orders of magnitude.

Open Surgery in Decline, or the Rise of the Minimally Invasive, Less Invasive, Interventional, Percutaneous and Other Alternatives to Surgery
Often stated, but never emphasized enough, is the compelling drive for treatments (that were all too recently delivered exclusively via surgery) to be associated with, or replaced by, ever-decreasing invasiveness. Device manufacturers have well established records for producing devices that not only minimize the trauma of surgery (e.g., laparoscopy) but also promise to make open surgery obsolete (e.g., percutaneous procedures like coronary anastomosis). Driving this trend is the persistent recognition that “collateral damage” in achieving clinical outcomes is unacceptable, whether from the perspective of the physician seeking to optimize results, the healthcare system seeking to minimize the costs of healthcare (or optimize revenue streams by being able to market the latest less-invasive techniques) or the patient seeking to minimize the impact of surgery on his/her busy lifestyle.

Disease State-Centered Marketplaces
Certain technologies in certain clinical areas remain the predominant if not exclusive option for treatment in those areas. However, in 2006, any legitimate competitive analysis of a market considers a multitude of different technology types. Case in point: any treatment for coronary artery disease will of necessity consider the competitive threat of bare versus eluting stents, angioplasty, atherectomy (waning but not gone), products for identification/treatment of vulnerable plaque, traditional coronary artery bypass, MIDCAB, OPCAB and other bypass variants (e.g. robotics), percutaneous bypass, atherosclerosis-reversing drugs and others. Compelling arguments must be created through the intrinsic advantages of new technologies in order to secure sought-after shelf space in the cost-fixated healthcare system armamentarium.

Materials Science Creating/Upending Markets
Underlying a stunning number of new technologies, from biodegradable/resobable stents, cellular scaffolds and a wide arrange of other implant types are the advances in materials sciences that are leading to the ability to engineer implants that now go well beyond providing solely structural roles. Driving these advances are the needs to improve upon the function of implants as static, inert devices that do not fully reflect the in situ need upon implantation, fail to adapt to changing conditions or otherwise do not provide the functions that optimize the end results of the implants’ use. Whether by impregnation with different substances or by the nature of the implant material employed, implants have improved considerably in being able to not induce an anti-inflammatory response, to provide anti-microbial function to the device, to minimize formation of blood clots and to avoid the effects like restenosis of vasculature following interventional procedures. With the need for implants frequently changing at some point after their implantation, more devices — biodegradable/bioresorbable stents, matrices/scaffolds for tissue engineering and others — are being developed that are either resorbed completely by the body or just enough to be expelled in whole or in part once their purposes have been served. Lastly, materials science and implant engineering in general have also been able to simply produce implants that are more easily deployed through tortuous twists in vessels or through narrow channels in endoscopic devices. Expectations are that more complex functions will be served by implants as a result of these trends and forces in development, from the increasing sophistication of drug delivery in various passive and active forms, to the ability of implants to respond via biofeedback to changing conditions in situ, and to providing increasingly sensor-like functions. Increasing demands are being made of the medical product marketplace — cost, competitive technologies, financial performance of public companies, etc. — but it seems clear that these demands are driving the proliferation of technologies that indeed satisfy them, sometimes with each advance creating ever greater demand in an endless progression. It also seems apparent that this “technology burst” is taking place simultaneously with the increasingly strident need for healthcare costs to get under control. The focus in the U.S. Congress on the need for Medicare reform, and reform in the U.S. healthcare system overall (up to an including the increasing drive toward universal healthcare), is gaining greater intensity and may well yield more than nominal changes to the system. The medical product industry is likely to both respond to these changes and facilitate solutions that we can scarcely imagine even now.

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Categories on medtech companies tracked

Not a great picture, I know, but this is partly due to technology limitation (mobile phone pic sent to go@mobile.com). But this is a screenshot of the one of the database data entry forms used in our internal company database, which in turn is used to track medtech companies (and other entities (e.g., VCs, providers, etc.) active in medtech. The categories include technology type (biopharm, device, pharm, biotech), major clinical applications (cardio dx, cardio tx, surgery, orthopedics, cell therapy, tissue engineering, patient monitoring, minimally invasive therapies, etc., etc.). We also segment by manufacturer, distributer, healthcare provider, etc.

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Unnecessary Surgery and Throwing the Baby Out with the Bathwater

Here’s another reference from BusinessWeek today, “Bypass that Operation”, on the same vein about doctors who don’t know what they are doing, including performing unnecessary surgery.   It suggests that many if not most of 400,000 bypass surgeries and 1 million angioplasties are unnecessary. 

While I find fault with the general tone of this article, glorifying Dr. David Eddy, his brilliance and his blunt challenge to healthcare that it needs better proof for the efficacy of its treatments, because the tone of this article blithely understates the fact that there is a clinical basis for the decisions doctors make, some patients actually do get better by the treatments prescribed, and wholesale dismissal of physicians’ education and training may have less to do with the facts than it does with Dr. Eddy’s ego and BusinessWeek’s need to make brash statements to gain attention.  This is not to say that I do not believe there are flaws in the process, but there is little justification for the kind of criticism that the BW article. What bothers me most about this article is that its sensationalistic approach to the subject and its flippant consideration of clinical practice on a grand scale trivializes the benefits of medicine and medical technology to patients.

By the way, in 2003, I was diagnosed with coronary artery disease, with blockage at 90% in one artery. While Dr. Eddy may thrive on the debate challenging the value of angioplasty and stenting (“mesh tubes” are not angioplasty, BusinessWeek), I know that however true it may be that some “cheaper alternative” might have done as well as angioplasty/stenting, there was no such alternative at the time. I am alive now. Replicate my experience with all others similarly diagnosed and that is precisely the reason for the high utilization of angioplasty/stenting. BusinessWeek’s cursory analysis failed to consider such an obvious driver.

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“Medical Guesswork” Exposing the Ugly Truth

I have always had a rather sanguine understanding of medicine, having been sensitized to its practical limitations for most of my life. Having been the son of a general surgeon and the nephew of a pediatrician, I saw many aspects of medicine that have tempered my thinking about treatment alternatives in the medical device industry. For this reason, when I came across the article in the May 29, 2006, issue of BusinessWeek Online, asserting that healthcare professionals really know little about which treatments actually work, I found agreement with the idea, and in some cases strongly so, but in other cases I felt the premise misses a few big boats.

From BusinessWeek: “The problem is that we don’t know what we are doing,” says Dr. David Eddy (the“mathematician and health-care economist” who coined the term “evidence-based medicine”), arguing that, bluntly, there isn’t very much of this in healthcare today. Further, according to BusinessWeek, “even today, with a high-tech health-care system that costs the nation $2 trillion a year, there is little or no evidence that many widely used treatments and procedures actually work better than various cheaper alternatives.”

The point at which I agree with this is that physicians have always been given wide latitude in determining therapeutic choices, by virtue of their education, their consideration of many different variables affecting patient condition and the suitability of any given treatment. What drives the physician’s decision-making is the availability of a reimbursible therapeutic option that specifically addresses the clinical problem to address the medium term need of the patient. By “medium term” I mean the need to solve the problem now, get the patient back on their feet and keep them that way not in any permament sense, but in a medium term sense. Does any cardiothoracic surgery think CABG is a permenent solution? Perhaps long term, but not permanent. Does any interventional cardiologist believe even a drug-eluting coronary stent is a permanent solution? Perhaps more likely to be permanent than bare stents or angioplasty alone, but certainly not permanent. So, doctors are applying the available therapeutic option for the longest solution that is viable. There are many stakeholders interested in the more expensive option — medical product manufacturers, physicians, even patients (who want the high-tech quick-fix). There are not many stakeholders advocating for cheaper options — perhaps HMO’s — but who is listening to them?

However, medical devices and drugs are already aggressively evaluated for their efficacy against controls, so the premise of this article, however well-founded, overstates the case when it comes to the use of medical products. The upshot of this article otherwise is to suggest that the upward spiraling U.S. healthcare costs are attributable to expensive treatments alone, when indeed the focus should be on clinical decisions themselves. Physicians are the ones who have been given the latitude to apply them or not, and until they have a different incentive system or until the evidence is much stronger for alternative treatments, absolutely nothing will change.

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Endoscopic GERD Treatment

Market shares for key players supplying GERD devices in the U.S. are shown in the chart at right.

Gastroesophageal reflux disease (GERD) is a growing problem affecting approximately 5% of the population. An estimated $10 billion is spent on GERD in the United States each year. It is primarily treated with medical therapies (e.g., proton pump inhibitors, or PPIs) for the majority of patients who present. For the remainder of the patient population (approximately 20%) who do not respond satisfactorily to PPI therapy, surgery or one of a variety of innovative endoscopic therapies that treat GERD are the next best alternatives. For some patients, neither palliative drug regimens nor major surgery are attractive options. Trends indicate that this market is moving towards GI endoscopic therapies as less invasive therapies continue to evolve and enter clinical studies. In 2006, the GI endoscopic anti-reflux device market is expected to be $10 million and by 2011 the market is expected to reach $50 million.Related Tags: , , , ,