A useful starting point for determining which adjunctive surgical closure and securement products are appropriate for different wound healing treatments is to recognize the major distinction between different wound types. Surgical wounds are usually appropriate for treatment with adjunctive surgical closure and securement products because they are created under clean conditions, the usual acute healing [...]
CryoLife's BioFoam, a protein hydrogel, received FDA approval today to begin an IDE for sealing of liver parenchymal tissue when conventional methods (e.g., ligature) prove ineffective.
The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted [...]
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 [...]
The terms “sealant” and “glue” tend to be used interchangeably in the surgical context, but in fact there is a difference in adhesive strength between sealants, pioneered by fibrin products (sometimes homemade) and the later, stronger glues of which cyanoacrylate-based products were the leaders.
Fibrin sealants represented a revolution in local hemostatic measures for both bleeding [...]
Below is a brief profile of Adhezion Biomedical, LLC, one of the companies active in the surgical sealants and glues market and profiled in the MedMarket Diligence report #S175. We occasionally highlight companies whose products, in our opinion, are poised to make an impact on medtech markets.
Founded in 2001, Adhezion Biomedical (formerly Spartan Medical Products, [...]
Hemostats have been used for over a hundred years to stop bleeding in surgical and traumatic wounds. Primarily these products were first introduced to prevent hematomas during surgery with the aim of preventing resultant infections. During the 1980s and 1990s, the popularity of hemostats increased rapidly as surgeons tried to avoid excessive use of blood transfusions [...]
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 [...]
Today at the 95th Annual Clinical Congress of the American College of Surgeons, Covidien introduced its V-Loc absorbable device for knotless, soft tissue repair.
"The V-Loc device is a breakthrough in dermal wound closure technology, and the feedback we are getting from surgeons who have tested the device is overwhelmingly enthusuastic," said Dr. Michael Tarnoff, Chief [...]
Mechanisms of Tissue Repair
As recently as 10 years ago, the biochemical mechanisms underlying tissue repair were still incompletely understood. For example, during the early 1990s as many as a hundred companies were actively engaged in clinical trials evaluating efforts to accelerate repair based on applying higher than physiological levels of growth factor to non-healing tissue. [...]
One of the key areas of interest for development of products in surgical sealing, closure and hemostasis is in neural tissue surgery, encompassing chronic stroke, spinal cord trauma, neurovascular defects, and brain tumor treatments. In the U.S. alone, there were some 5.6 million patients in this category in 2008 who could benefit from these products.
The [...]
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