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 [...]
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 post-operative [...]
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 parts, [...]
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 [...]
MedMarket Diligence’s 2009 report #S175 is an analysis of the companies exploiting medical devices targeted at the surgical securement market to examine the products they market and the timelines associated with their approvals.
A greater awareness of regulatory approval mechanisms and requirements around the world has become apparent in this market sector, and we believe this [...]
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, considering [...]
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 [...]
Cardiovascular disease is the leading cause of mortality in the United States with heart disease affecting 13 million people. Approximately 10% of these patients are estimated to be candidates who, as part of their primary treatment are also candidates for the most advanced technologies in surgical securement. Current uses of surgical securement technologies in cardiovascular [...]
In the MedMarket Diligence report #S175, we characterize by clinical specialty the types of value offered by surgical sealants, glues, hemostats and other wound closure and surgical securement products.
Category I: Important and Enabling
Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications [...]
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