Caseload in surgical sealants, glues, hemostasis

Out of 81 million Americans diagnosed with some form of cardiovascular disease every year, approximately 6.2 million cardiovascular procedures in the United States have the potential to benefit from improved hemostasis, sealants and glue products. Procedures that fall into this category include open heart bypass procedures with vein harvesting and many heart revascularization procedures, aortic valve replacements, mitral valve replacements, carotid endarterectomy, femoral distal bypass, and femoral popliteal bypass.

Some abdominal aortic aneurysm treatments also fall into this category along with some pacemaker insertion procedures. The vast majority of cardiovascular procedures (84%) fall into Categories II and III. These procedures can use new surgical closure and securement products to improve cost-effectiveness by reducing infection and post-surgical fibrous adhesion formation; they reduce morbidity by improving procedure effectiveness and cutting down surgery time. Although cosmetic improvement can also result, this is rarely the driver for using these improved products within the cardiovascular arena.

Many coronary angioplasty, cardiac catheterization, and carotid endarterectomy procedures fall into Category III procedures as they have potential to benefit from the appropriate use of these products.

Of more than 9 million musculoskeletal surgical operations worldwide, a large number (approximately 4 million) involve minimally invasive arthroscopy or are closed fractures that are not currently addressable by hemostats, sealants and glues. However, open trauma cases, knee reconstruction, some hip reconstruction procedures, and all spine fusion procedures have the potential to benefit from improved appropriate use of hemostat, sealants and glues. Some of these procedures, as well as total knee replacement procedures, cause the patient to lose substantial quantities of blood. Effective use of sealants/hemostats can prevent loss of time during surgery, reduce the requirement for replacement blood products, and significantly improve rehabilitation due to reduced morbidity. As a result, most of these procedures fall into Categories I, II, and III, as shown above. These treatments may benefit from improved securement and soft tissue bioresorbable securement products.

Also there are 460,000 fusions and 470,000 discectomies (with and without disc replacement) performed in the United States per year.

Particularly in the case of fusion, patients may require replacement of up to half of the blood in their bodies. These procedures can also take up to six hours to perform, and effective hemostasis can significantly improve cost-effectiveness by saving surgical time and related costs, improving recovery and outcomes for the patient (e.g., reduced risk of infection) and reducing morbidity.

There are approximately 2.5 million procedures worldwide to reconstruct joints. Minimally invasive procedures have recently reduced the burden of these procedures, but reconstructive orthopedic procedures are likely to increase with growth of the aging population and with increased recreational activity. These procedures can benefit from improved use of products covered by this report and we forecast a compounded annual growth rate of 6% in this category. Typically, tourniquets are used to prevent excessive bleeding during many of these procedures; it is assumed that lack of blood flow results in morbidity of tissue and delayed recovery as well as leading to increased complications, although the reduced need for blood transfusion is thought to outweigh these disadvantages. The introduction of effective sealants and hemostats offers the possibility of selectively reducing bleeding at sites of reconstruction without the concomitant effect of increased morbidity.

A relatively small number of procedures (1.0 million) such as synovial fluid replacement and minimally invasive discectomy offer potential to benefit from improved closure; these currently fall into Category IV. We expect a new group of procedure-enabling high-strength glue products to evolve, which will in the future enable gluing of ligaments, tendon, bone etc. within the orthopedic arena. Although a number of cement and new bone graft substitute materials exist that have glue-like characteristics, none yet have the weight-loading potential or the torque- strength characteristics to meet the demand to fix bone fragments together without hardware support.

A number of digestive tract procedures such as colon surgery and appendectomy can benefit from the use of improved hemostats and sealants. In these cases, loss of blood is not the major challenge, but infection and appropriate securement of the repaired alimentary organ is essential. Most of the potential in this category falls into Categories II and III.

Urological and gynecological procedures include transurethal prostrate resections, bladder surgery, prostatectomy, hysterectomy and surgical resection of adhesions, as well as cesarean sections. Hemostasis and sealing in these procedures is critical to prevent complications that can result from excessive bleeding (Category II). In a number of cases, effective hemostasis can prevent excessive loss of blood and is essential for safe and effective outcomes. There are also a large number of procedures (for example, cesarean sections) for which cosmetic outcome is important. In addition, there is an increasing number of minimally invasive procedures for which this range of products appears to offer no advantage.

Neurosurgery (4.2 million procedures in the United States) represents the surgical field most vulnerable to the effects associated with healing. Inflammation, angiogenesis, and generation of fibrous tissue, all attributes of normal tissue repair, cause problems for neural tissue. Effective hemostasis and sealing of blood can avoid these traumatic effects and are vital to reduce morbidity, so most of these procedures fall into Categories I and II.

Of the roughly 11.1 million cosmetic surgery procedures worldwide, a small number (including some breast augmentation/reduction procedures) require effective hemostasis and sealing to prevent blood loss and resultant transfusion, with approximately 60,000 also benefiting from improved clinical outcomes (e.g., faster healing) associated with this hemostasis. The potential in the cosmetic arena comes from improved cosmesis and reduced scarring after surgery (particularly facelifts, abdominoplasty, and augmentation procedures).

Most traumatic wounds offer potential to be appropriately treated with hemostats, sealants and glues. Many lacerations can be adequately treated with high-strength glue products; this would avoid a secondary visit to a medical center for removal of sutures with associated costs. For example, conservative accident and emergency costs for closure of a small bleeding trauma laceration with sutures, local anesthetic, antibiotic cream and suture removal kit are approximately $75 (before labor and time are included). In acute care hospitals in the United States, 5%–10% of patients develop hospital-acquired (nosocomial) infections, many of them in wounds. The cost per wound has been estimated as ranging from $3,000 to $27,000.

Cyanoacrylate products can be used without anesthetic and without sutures. In addition, because cyanoacrylate sloughs off the skin surface, there is no need for a removal kit.

Source: MedMarket Diligence, LLC; Report #S180, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2008-2015.”

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