Technology | March 09, 2009

SyntheMed's REPEL-CV Approved for Use After Pediatric Cardiac Surgery

March 9, 2008 - Biomaterials company SyntheMed Inc. has received FDA approval of its pre-market approval (PMA) application for REPEL-CV Adhesion Barrier for use in pediatric cardiac surgery patients.

REPEL-CV is a bioresorbable adhesion barrier film based on SyntheMed’s proprietary polymer technology. When placed over the surface of the heart at the conclusion of an open-heart surgical procedure it is designed to reduce the severity of adhesions that form between the surface of the heart and adjacent tissue surfaces following the surgical procedure. REPEL-CV is designed to provide the therapeutic benefit and then degrade so that it is cleared from the surgical site.

In a randomized, controlled clinical trial conducted at 15 pediatric cardiac surgery centers throughout the U.S., over 70 percent of the REPEL-CV treated patients were completely free of clinically significant adhesions, the most severe grade of adhesions measured, as compared to less than 30 percent in the control patients.

For more information: www.synthemed.com

Related Content

SherpaPak Cardiac Transport System Cleared for Pediatric and Small Donor Hearts
Technology | Cardiovascular Surgery | February 01, 2019
Paragonix Technologies Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) for a design...
Transplanting Pig Hearts Into Humans One Step Closer. A pig heart, shown here, is very similar in size and anatomy to a human heart. For this reason, pigs are used extensively in pre-clinical animal testing for new implantable cardiovascular devices. If pig hearts could be used for human transplantation, it would greatly alleviate shortages of donor human hearts.

A pig heart, shown here, is very similar in size and anatomy to a human heart. For this reason, pigs are used extensively in pre-clinical animal testing for new implantable cardiovascular devices. If pig hearts could be used for human transplantation, it would greatly alleviate shortages of donor human hearts.

News | Cardiovascular Surgery | December 11, 2018
The scientific journal Nature recently published an article from Munich University Hospital which describes the long-...
Bilateral Artery Use Does Not Improve 10-Year CABG Outcomes
News | Cardiovascular Surgery | September 06, 2018
While it is firmly established that the use of one internal thoracic artery can improve life expectancy in coronary...
Mandatory Public Coronary Artery Bypass Grafting Reporting Associated With Better Patient Outcomes
News | Cardiovascular Surgery | April 30, 2018
Mandatory public reporting of coronary artery bypass grafting (CABG) results in Massachusetts was associated with...
Gecko Biomedical Receives CE Mark Approval for Setalum Sealant
News | Cardiovascular Surgery | September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery | September 08, 2017
September 8, 2017 — ClearFlow Inc.
Videos | Cardiovascular Surgery | July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Intensive Glycemic Control Program Produces Significant Per-Patient Cost Savings for CABG Surgery
News | Cardiovascular Surgery | May 25, 2017
A new study from Emory University observed a near-20 percent reduction in perioperative complications, a 1.2-day...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery | May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
Overlay Init