Sutures and staples are at an aging stage in their product life cycle; there are numerous predicate devices, and the materials are well established and cover most of the spectrum of clinical need for suturing. However, a great number of procedure-enhancing devices have been developed in the last seven years, particularly as minimally invasive surgery and robotics have created a need for new instrumentation to secure tissue. Good examples of this are the development of stapling devices for pneumostasis and securement devices for arthroscopy. This illustrates the fact that once clinical evaluation of a new product has been completed to the satisfaction of regulatory authorities for launch of the new product, incremental developments and clinical evaluations are usually continued throughout the lifetime of the product.
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Similarly, a number of hemostats and devices for preparation of autologous fibrin sealant have also been available for some time for prevention of blood loss (e.g., from Harvest Technologies). These materials and devices are generally approved for hemostasis, and companies have attempted to develop new physical forms, mixes, and delivery systems to speed up and improve the usefulness of these products.
Commercial forms of pooled human fibrin have been used clinically outside of the United States for many years, for reasons of preventing infection; however these products did not reach this stage of clinical evaluation in the United States for many years. In 1996, the FDA approved the clinical investigation of fibrin sealants and a number of trials commenced. These resulted in a cascade of approvals for specific indications and claims, and considerable off-label use and clinical evaluation. Fibrin sealants have been employed and reported to prevent bleeding in many types of procedures including cardiovascular (e.g., restiotomy), neurological (e.g., craniotomy), orthopedic (e.g., knee replacement), spinal (e.g., vertebral fusion), cosmetic (e.g., breast augmentation) and digestive (e.g., closure of temporary colostomy).
Alternatives to fibrin sealant have been developed and launched with specific claims and targeted at specific indications. Cyanoacrylates have been employed as external suture replacements since 1997 in the United States. These materials started life as off-label sports injury products; they were approved with limited claims, which were then expanded to include “reduced injection risk,” and general use of these products for topical application is well established; reports from major suppliers suggest that approximately 20% of the accident and emergency opportunity for treating lacerations in the United States is penetrated by cyanoacrylate glue products.
Low cost if short follow-up, (e.g., cuts and grazes) and low-cost procedure
High cost if long-term follow-up required, (e.g., ligament repair) and high cost procedure
Some procedures require short follow-up periods (e.g., hemostasis endpoints and use of cyanoacrylate on cuts)
Some procedures require at least two years follow-up (e.g., musculoskeletal sports injuries)
Community care (lacerations)
Doctor’s surgery (accidents)
Critical care (e.g., burns)
Some devices and developments have predicate devices which allow more rapid approval. Autologous products are also relatively quick to develop
New biologicals, complex mixtures of biomaterials, and new chemical entities require extensive validation and testing
Device for delivery
Can accelerate clinical approval and improve clinical efficacy
Can complicate clinical development if both device and product are new