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 [...]
Fibrin and other medical/surgical sealants have developed a broad repertoire of applications supported by their utility addressing different wound and tissue types.
Below is a sampling of applications of fibrin and other sealants:
Local hemostatic measures for both surgical and trauma cases
Surgery in patients with bleeding disorders (e.g., hemophilia, severe thrombocytopenia) and non-bleeding cases with suspected fluid [...]
CryoLife Announces First Clinical Use of BioFoam(R)
(Reuters )
BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed. BioFoam received CE mark approval for … | See original press release
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The use of BioFoam for liver resection represents a strong trend toward the expanded use of sealants [...]
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 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 parts, [...]
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 [...]
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