Glues and sealants are making inroads in surgical sectors
By CYNTHIA DRAKE BBI Contributing Writer Ants, thorns, cautery, needles, staples and glue. What do they all have in common? All these have been used to close wounds at some time or another. From lacerations treated in offices or emergency rooms to major surgical incisions, somebody is being sewn back together every moment of the day and night. This makes wound closure a big business – more than $1.45 billion yearly worldwide from more than 319 million single-use, sterile, individually packaged sutures. The first suture alternative, introduced in the 1970s, was a stapler. Stapling devices now represent an $800 million worldwide market. Market leaders in the suture niche are, of course, Ethicon (Somerville, New Jersey), a Johnson & John-son (New Brunswick, New Jersey) company, with a 72% market share, and U.S. Surgical (USSC; Nor-walk, Connecticut), with a 25% share. In the stapler business, USSC, which is being bought by Tyco Inter-national (Exeter, New Hampshire), is estimated to have a 55% share and Ethicon EndoSurgery (Cincin-nati, Ohio) a 45% share. The overall market for stitch-es and staplers has been declining, however, as more and more surgical procedures are being done mini-mally invasively. Smaller incisions mean fewer stitch-es or staples to close those incisions. It’s not just the outside skin closure market involved here. Sutures/staplers are used to put tissues back together and to stop bleeding or reinforce anasta-moses in all the surgical specialties. One of a medical student’s first challenges is to learn to sew and tie knots. Anyone ever experiencing a medical student’s closure of a laceration will remember that surgical stitching takes time and a certain degree of skill. A lot of that time is about to be saved in the U.S. Surgical glues and sealants are coming; some are already on the market. Time is money, as they say. The use of glues and sealants is bound to save time and therefore money. For patients, these products should mean less pain and perhaps fewer hours in the hospi-tal. For surgeons, they should shorten surgical proce-dure times. For payers, some of these products may shorten length of stay. For some manufacturers, glues and sealants will be big business. The total potential worldwide market for suture alternative glues and sealants and arterial closure devices is expected to top $2 billion by the year 2003. There are products designed to replace both sutures and staples. They are glues or tissue sealants that are brushed, sprayed or dripped onto the tissues being joined. These alternatives could eventually take as much as 40% of the overall suture/stapler market. The three segments of the market for suture use include emergency room (ER) wound closure; operat-ing room (OR) skin wound closure; and intraoperative internal hemostasis and tissue closure. Product perfor-mance parameters vary for each of these segments. ER wound closure An estimated 12 million emergency room visits in the year 2003 will involve wound closure. World-wide ER visits will number about 26 million. With a price per use of $17, the potential market for ER wound glues will be $200 million in the U.S. and more than $440 million worldwide. Some of these wounds will not be suitable for glue closure, so the best this niche will produce is probably about 45% of the overall potential market – or $201 million world-wide in 2003. The leader in the ER wound closure sector is Clo-sure Medical (Raleigh, North Carolina). The compa-ny’s Dermabond product is expected to launch in the U.S. by the end of 1998. Closure has enormous mar-ket advantage because of its distribution agreement with Ethicon for the ER market. Dermabond also is user-friendly. It can be spread over the wound with one hand. OR wound closure In 2003, an estimated 32 million surgical proce-dures will be performed. Worldwide numbers will approximate 47 million. About 35% of these will be amenable to wound closure by one of the glue prod-ucts. With a price-per-use estimated at about $20 and a market penetration of 35%, a worldwide market of $331 million can be predicted in 2003. Tensile strength is an important parameter for wound closure in the OR. Wounds are usually some-what more extensive than those closed in emergency rooms. The surgical incision needs to resist the pres-sure from internal organs as well as the pulling strength of muscles near the wound. Indermil from Loctite and Liquiband from MedLogic may take the lead in this segment of the market because of the chem-ical composition of the products. As 4-carbon (butyl) cyanoacrylate polymers, both products will have high-er tensile strength than that currently offered by Der-mabond. Liquiband has an additional product advan-tage. Its formulation is expected to contain antibiotics, allowing the company to make anti-infection claims. Intraoperative hemostasis and tissue closure Tissue glues and hemostatic compounds are being developed and launched to compete for uses in intraoperative hemostasis and internal tissue closure.
Rather than using the “superglue” cyanoacrylate products found in the ER and OR wound closure seg-ments, another technology – fibrins – is emerging. Fibrin is considered to be much better suited for inter-nal use, because it is completely biodegradable and it is both a hemostatic (clot-forming) agent and a glue. Fibrin is the body’s own acute tissue cohesive. It is the glue in a blood clot. The mechanism of blood clotting is the first stage in the wound-healing cascade. The American Red Cross recently announced two new sealant products made from the blood’s own clotting agents – fibrinogen and thrombin. One of the products is a rapidly expanding foam sealant. Scien-tists believe this foam can be sprayed into a gunshot wound to patch torn vessels. The second Red Cross product is a bandage with the sealant imbedded on a matrix of absorbable sutures. It may be useful for other trauma surgeries such as torn liver, spleen or kidney. Clinical use is not expected until 2000. Fibrins won’t hold the intraoperative hemostasis niche alone, however. Some cyanoacrylate products and Focal’s (Lexington, Massachusetts) polyethylene glycol glue FocalSeal also will be used. Analysts predict that the users of internal cohesives and sealants will be current users of “homemade” glues, users of sutures, and those using sealants and glues plus sutures. Fewer procedures will be eligible for this niche of the suture alternative market, but price-per- use is expected to be considerably higher. Analysts cautiously estimate the potential market for these prod-ucts at 4 million cases in the U.S. by 2003 and about 11 million worldwide. With a price-per-use expected to average $250, the potential market is quite large. Arterial puncture closure Interventional radiologists and interventional car-diologists don’t make surgical wounds – they punc-ture through the skin to the vessel of interest. But those little holes have to be closed, too. Traditionally, this has been accomplished with manual pressure, sandbags over the groin incision and some mechanical devices. Patients had to remain in a hospital bed for hours, waiting for the puncture site to stop bleeding. New arterial puncture closure devices on the market from companies like Datascope (Montvale, New Jer-sey), Kensey Nash (Easton, Pennsylvania) and Perclose (Menlo Park, California) are changing the way inter-ventional procedures are handled. Using these prod-ucts, an interventionalist can reduce the patient’s time spent in the hospital, sending them home almost imme-diately after a cardiac catheterization, for example. Analysts estimate more than 3.9 million interven-tional procedures will be done in the U.S. in 2003, about 6.6 million total worldwide. With a price per use of $225 and a 60% market penetration, revenues from this niche could total nearly $900 million world-wide in five years.
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