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>SyntheMed Completes $1.0 Million Equity Placement
>SyntheMed Receives Brazilian Regulatory Approval for REPEL-CV™
>SyntheMed Receives Russian Regulatory Approval for REPEL-CV™
>REPEL-CV™ Adhesion Barrier Receives Endorsement of Kids With Heart
>SyntheMed Receives US Patent on Novel Polymer Technology
>FDA Approves SyntheMed's REPEL-CV® Adhesion Barrier for use in Pediatric Cardiac Surgery
Adhesions are fibrous bands of scar tissue that form between apposing tissue surfaces as a result of the bleeding and trauma involved in a surgical procedure. During secondary open-heart surgical procedures, these adhesions must be removed to provide the surgeon with good access to and visualization of the surgical site. This process presents surgeons with several challenges. Adhesions can obscure key anatomical landmarks, posing the risk of inadvertent damage to critical structures and vessels. Excessive bleeding can occur during dissection of the adhesions requiring additional units of transfused blood. In addition, the process of dissecting the adhesions can add an hour or more to the surgical procedure, thus resulting in the patient being under anesthesia for a prolonged period of time, which increases the risk of neurologic injury.
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*REPEL-CV Adhesion Barrier is approved by Health Canada for use in pediatric patients who undergo open heart surgery. It has CE mark approval for use in all cardiothoracic surgical procedures.
** Lodge AJ, Wells WJ, Backer CL, et al. A Novel Bioresorbable Film Reduces Postoperative Adhesions After Infant Cardiac Surgery. Ann Thorac Surg. 2008;86(2):614-21.
Cardiothoracic surgeons realize that the dissection of retrosternal and intra-pericardial adhesions is an unavoidable and time-consuming part of secondary open-heart surgical procedures. They also realize that the resulting patient risks of damage to critical tissue structures and prolonged anesthesia exposure negatively impact the delivery of quality patient care. Approved to address the problem of cardiac adhesions,* REPEL-CV Adhesion Barrier reduces the severity of post-operative adhesions that inevitably form as a result of the trauma and bleeding that occur during the surgical procedure.
REPEL-CV Adhesion Barrier, a transparent, resorbable, biocompatible film does not obstruct the surgical site during application, providing a clear view of key anatomical landmarks for safe, optimal application. It's very easy to use, requiring no change in surgical technique and adding minimal time to the surgical procedure.
In a recent randomized, controlled clinical trial conducted at 15 cardiothoracic surgery centers, 70.4% of patients treated with REPEL-CV Adhesion Barrier were free of clinically significant adhesions at the time of the secondary surgery. This compares with only 28.6% of the control patients.**
REPEL-CV Adhesion Barrier reduces the risks and complications of secondary open-heart surgery, thereby improving the quality of patient care.
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