Diverse technologies have a surprising number of common threads, whether in the technologies themselves or in the clinical applications. For this reason, manufacturers need to consider that: 1. A technology platform can be the launchpad for products in clinically diverse areas. Case in point, cell therapy, which as a fundamental scientific discipline can have uses [...]
High-strength surgical glue products were approved for topical closure applications in the United States in the late 1990s. Outside the United States, high-strength glues and adhesives have been approved in some countries for a number of years and have built up a track record of use in internal surgery. With time, high-strength glues will come [...]
A considerable number and type of different biologically-based glues and adhesives are being studied for their potential use in human applications for wound closure. We previously addressed this in our post Sandcastle worms, mussels, burrowing frogs and gecko feet. To that list, we can now add a glycoprotein web glue from the golden orb weaving [...]
Covidien gained FDA approval this week for its DuraSeal for the sealing of sutured dural tears, which occur in 10% of all spinal fusion procedures. (See DuraSeal(TM) Spine Sealant Receives FDA Approval.) DuraSeal, originally developed by Confluent Surgical, is a PEG (polyethylene glycol) solution and a trilysine amine solution, that has been shown effective in preventing intra-operative and [...]
The use of fibrin and other hemostats expanded rapidly in the 1980s in Japan, driven by the strong cultural desire to avoid the need for blood transfusions. In addition, regulatory barriers to launching homologous pooled plasma-derived products in Europe were not as stringent as those imposed by the U.S. FDA in the late 1980s and [...]
The vast majority of sutures, staples and endostaples are used following procedures involving acute surgical wounds. Typically, chronic wounds do not involve use of suture and staple products unless some degree of surgical intervention is employed to remove necrotic tissue or to create a new acute wound bed to aid healing. Sutures comprise two component [...]
High-strength glue products were approved for topical closure applications in the United States in the late 1990s. Outside the United States, high-strength glues and adhesives have been approved in some countries for a number of years and have built up a track record of use in internal surgery. With time, high-strength glues will come to [...]
The market for surgical closure and securement has entered a phase in which major driving forces are the introduction of new procedures and techniques by the surgical profession, the development by the medical device industry of new wound closure devices and biomaterials, and the growing willingness of surgical specialists to use these devices in appropriate [...]
Products used in surgical closure and securement include multiple types, from sutures, staples and tapes to fibrin sealants, fibrin glues, high-strength glues (e.g., cyanoacrylates, others), hemostasis and others. Clinicians managing surgical or traumatic wounds choose the appropriate product or product combination based on wound type, location, patient status and other considerations. From the manufacturer’s standpoint, [...]
In cardiovascular and spine surgery, multi-billion dollar markets were created from entirely new procedures between 1980 and 2000, with subsequent segmentation in later years particularly as new minimally invasive procedures were developed towards the end of the 20th century. In the cardiovascular arena, the development of new procedures for angioplasty and bypasses in the late [...]
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