Surgical Adhesives: Can Liquids Stick It to Suture and Staples?
Edition: October 2001 - Vol 9 Number 10
Author: John Andrews
If Madison Avenue were assigned to devise a slogan that captures the health care technology market, it might come up with something like this: ''America: Leaders in medical device production, laggards in medical device adoption.''
Sounds flippant, but it accurately sums up the irony of the U.S. health care system. While manufacturers race to get innovative new products to market, providers here are usually the last to embrace them. And even though many technologies are first used overseas, new techniques usually don't emerge until we implement them.
Such is the case with alternative wound closure products, namely liquid tissue sealants and adhesives. Although they've been widely used in Europe and Asia for several years, they are just now starting to seep into surgical suites across the country. And with utilization rates expected to overflow (at least by manufacturers' estimates), it begs the question of whether we may be on the verge of a major shift in wound closure procedures one where glues and gels replace nylon and staples.
Although manufacturers may hope for such a development, they are reserved in their market forecasts, stating that their products are designed as adjuncts to current surgical techniques.
''We're not looking to rewrite surgical procedures,'' said Patrick Del Medico, director of marketing for Sarasota, FL-based Haemacure. ''We want to be a complementary addition to them.''
Still, if the efficacy rates of these products are as high as manufacturers say they are, and if their U.S. growth projections are accurate, we may indeed be on the cusp of a wound-closure revolution.
Of course, demand is key. If the syllabus for a recent Cambridge Healthtech Institute conference on tissue sealants is any indication, surgeons are impressed by suture alternatives and are requesting them for the OR. What's more, manufacturer research shows that domestic sales are climbing.
However, one manufacturer's experience tempers the outlook somewhat. Dermabond, a liquid adhesive introduced by Raleigh, NC-based Closure Medical, reportedly struggled to persuade doctors to switch from sutures to an adhesive. Even so, the company remains optimistic, hoping that Johnson & Johnson (New Brunswick, NJ) can work some marketing magic as the brand's authorized distributor. A recent company press release projected a 35% increase in sales this year.
South San Francisco, CA-based sealant manufacturer FibroGen conducted a study with market research firm Frost & Sullivan (Mountain View, CA) and determined that the U.S. market for tissue sealants will grow to $341.6 million by 2005, an annual growth rate of 81% from $5.3 million in 1998.
In addition, Haemacure reports that it has more than 1,000 hospital customers for its product line, while Cambridge, MA-based Genzyme Biosurgery lists some 235 thoracic surgery centers as users of its FocalSeal-L brand sealant.
Yet, even though there are indications that tissue sealants, surgical adhesives and other suture alternatives are penetrating the market, these products have yet to reach group purchasing channels and are still an enigma to many materials managers among them.
''It's a lack of education about the wound closure market,'' said Tina Barletta, director of FocalSeal-L sealant marketing for Genzyme Biosurgery. ''Physicians are a target audience. If we can convince them to use the product, they then need to communicate its efficacy and cost effectiveness to others in the hospital.''
Likewise, Del Medico said the adoption curve has so far fallen below expectations for its Hemaseel brand hemastatic agent and sealant.
''Getting trials and surgeon interest has been slower than we originally thought,'' he said. ''A big reason for this is that these products are not currently a part of the surgical routine. The good news is that when a surgeon uses it, the product makes an impact.''
Presently, manufacturers are concentrating their marketing efforts on physicians and nurses, but they agree that acceptance by purchasing decision-makers is critical to their success. It stands to reason that if they can sell materials managers on the products' cost effectiveness, it could pave the way for the revolution to begin.
That's a big ''if,'' however. Before materials managers can decide whether they should jump on the sutureless bandwagon, they first need to learn what these products are, how they work and how they're used.
The scoop on sealants
Tissue sealant and surgical adhesive manufacturers tout their products as a significant progression in wound closure.
''What started with cat gut eventually led to staples and now people are looking at biological ways to seal wounds,'' said Jack Anthony, FibroGen's vice president of development. ''It's a complex area and competition among manufacturers is tight. There are a lot of companies out there making a wide range of products in this area. In fact, surgeons are presented with so many choices that it's difficult for them to try them all and figure out which ones are the best.''
Though it's a tall order to run a complete list of all the companies offering these products and the wide range of properties they contain, they can be categorized into three basic product groups: sealants, which cover an incision; adhesives, which approximate tissue; and hemastatic agents, which curtail bleeding. Their composition is either organically or synthetically based, employing elements such as collagen, thrombin, fibrin, cyanoacrylate, cross-linked albumin or polyethylene glycol polymers.
From the information released by vendors, product application is versatile, designed for numerous procedures, including cardiovascular, pulmonary, colorectal, otolaryngologic, neurologic and urologic surgeries. More are planned, though off-label usage is already occurring, manufacturers say.
For instance, Hemaseel is cleared by the Food and Drug Administration as a hemastatic agent and sealant, but can be used to stem lymphedema leakage in mastectomy patients, reducing or eliminating the need to insert a drain.
The products are used mainly to seal internal or external incisions with some, like FocalSeal-L, changing molecular properties. During the three-step treatment, a blue light transforms the material from a liquid state to a gel that forms an elastic seal designed to last 14 days, according to the company.
One of Haemacure's newest applicators, called Hemamyst, is an aerosol spray device that is designed to allow the surgeon to spray or mist a large vascular area so that it covers a large surface area. Del Medico added that while the application is smoother and more uniform, it consumes less product.
''This market will grow to include even more new products and procedures,'' Anthony said. ''There will also be new formulations to help broaden the application.''
Materials managers face a litany of product choices in this new category and have to weigh the respective merits of each in order to decide which ones if any should be purchased. Of course, cost issues are the major influence.
''The important thing is raising the right questions,'' noted Nancy Reaven, president of La Canada, CA-based Strategic Health Resources. ''It has to do with how the sealants change either the clinical protocol itself or the clinical outcome. Depending on how they change the surgical process, there may be some distinctive benefits that the hospital doesn't even begin to speak to.''
Determining the impact of a new product requires looking beyond the surface and into its long-range potential, Reaven said.
''When you look at the common supplies in conventional surgical approaches, you find that the actual accumulated cost of those supplies are more expensive than you think,'' she said. ''Compare how the new technology improves on the conventional method. Can it expedite the procedure? If it shaves off time, you can schedule more procedures per day, improving the bottom line.''
Efficacy rates, which manufacturers insist are stellar, are also an important factor. By reducing complications, hospital stays and re-admissions, the products can pay for themselves several times over, they say.
Del Medico claims that Hemaseel has had 5 million uses worldwide without an adverse event. Barnetta points to a controlled study of pulmonary patients, with whom air leaks are a common complication. Genzyme's tests showed 92% of its FocalSeal-L patients came out of surgery with no air leaks, compared with 29% for a control group.
If these results are accurate, they are the type of numbers that materials managers should seriously consider when evaluating costs. And Reaven strongly advises materials managers to avoid fixating just on the price. Remember, she said, the acquisition price of the technology is ''almost never'' the true cost to the hospital.
''Materials managers are primarily concerned with meeting their own budgets, so they pay close attention to costs-per-quarter,'' she said. ''In that sense, they're not directly benefited by promoting technologies within the hospital that will contribute to the bottom line but will bust through the budget. Going over budget can make you look bad at first, but if you can show that the excess dollar amount can be made over 100 times by using them instead of conventional products, it improves the hospital's overall financial picture.''
It would certainly help materials managers if they were fully integrated into hospital operations instead of just managing their own supply budget, Reaven said. ''That way, they would have a direct interest in saving procedure time and hospital costs not just the cost of supplies,'' she said.
Even if materials managers had an equivalent to the Pharmacy and Therapeutic Committee they would have an easier time justifying new technology purchasing decisions, said Kevin O'Donnell, president of Lewisville, TX-based Healthcare Resources of America.
''If they had the control that pharmacy has, they wouldn't have these acquisition and expense problems,'' he said. ''As it is, they have a much tougher time with it.''
The reality is that materials managers do have a responsibility to keep an eye on supply cost spikes. Bringing in tissue sealants and/or surgical adhesives certainly represent a budget bulge which, by manufacturers' estimates ranged from $200 to $450 per procedure. However, decreasing conventional suture purchases could also defray some of that cost, sources say.
Ultimately, it comes down to information, a critical resource in helping materials managers decide how they want to proceed with tissue sealants and adhesives. Reaven recommends that materials managers should be in regular contact with manufacturers as well as discussing the matter with surgeons.
''The manufacturers should provide hard evidence of cost efficiency because for better or worse, they are developing that data,'' she concluded. ''If the data is credible, if their presentation vehicle is flexible enough for hospitals to make changes in their basic assumptions, then it serves a valuable purpose.''
This article was written for First Moves Magazine, sister publication to Repertoire. John Andrews is a Des Plaines, IL-based freelance correspondent.