Navigation Links
FDA Approves SyntheMed's REPEL-CV(R) Adhesion Barrier for Use in Pediatric Cardiac Surgery
Date:3/9/2009

ISELIN, N.J., March 9 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Pre-market Approval (PMA) application for REPEL-CV(R) Adhesion Barrier for use in pediatric cardiac surgery patients. REPEL-CV is a bioresorbable film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the formation of post-operative adhesions (scar tissue).

"The FDA approval of REPEL-CV as the first anti-adhesion product for use in cardiac surgery marks a major milestone for our company," stated Robert P. Hickey, President and Chief Executive Officer, SyntheMed, Inc. "We now look forward to providing US-based cardiac surgeons with a means of reducing the risks to which their pediatric patients are routinely exposed during secondary open-heart surgical procedures. We are engaged in discussions with FDA personnel to define the clinical data required to expand the use of REPEL-CV to include adult cardiac surgery patients."

REPEL-CV will be marketed in the United States through a direct sales force comprised of both company and independent sales representatives. REPEL-CV has CE Mark approval for use in all cardiac surgical patients and is currently marketed through a network of independent distributors in the European Union and in several Southeast Asian countries.

About Cardiac Adhesions

Adhesions, or scar tissue, occur after virtually all open-heart surgical procedures, often resulting in the heart becoming attached to the sternum and other surrounding tissue surfaces. The presence of adhesions represents a prevalent and serious complication in secondary surgical procedures, increasing the length, cost and risk of the surgical procedure.

A
'/>"/>

SOURCE SyntheMed, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)
2. FDA Approves Apidra(R) SoloSTAR(R) - a Prefilled Disposable Insulin Pen
3. European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI
4. Encouraging high-risk research: DFG approves funding for 2 new Reinhart Koselleck projects
5. FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout
6. FDA Approves Clinical Studies of a Novel Anti-Cancer Drug Developed by Italian Researchers
7. FDA Approves KAPIDEX(TM) (Dexlansoprazole) delayed release capsules for the Treatment of GERD
8. Bion Announces PENNVEST Board Approves $7.8 Million Financing for Kreider Farms Dairy Project
9. Monsanto Board Approves 10 Percent Dividend Increase
10. FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis C
11. MultiVu Video Feed: U.S Food and Drug Administration (Fda) Approves Latisse(TM) --
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... Dec. 22, 2014  ( www.competitivehealth.com ) — Competitive ... medical bill review and advocacy service, has signed an ... WellCard Savings discount health services marketplace. 63% ... more than they expected to pay. As part of ... costs, WellCard Savings is pleased to offer medical bill ...
(Date:12/22/2014)... 22, 2014 Fertility Associates of Memphis ... Bank USA , a network of more than 20 ... partnership, patients have fast access to a national pool ... IVF . Fertility Associates of Memphis is the only ... treatment option. , Dr. William Kutteh , director ...
(Date:12/19/2014)... BioPlus Specialty Pharmacy (BioPlus), one ... of Nick Maroulis, Pharm.D. to the newly created position ... In this position, Dr. Maroulis will continue to manage ... of our multi-site pharmacies as the company expands. Dr. ... that time he has served in many different capacities ...
(Date:12/19/2014)... Dec. 19, 2014 Bina Technologies, Inc. (Bina, ... that they have been acquired by Roche (SIX: RO, ... privately held company that provides a big data platform ... (NGS) data for the academic and translational research markets. ... and will continue to focus on development of their ...
Breaking Biology Technology:WellCard Savings Announces CoPatient Medical Bill Review Service for Members 2Fertility Associates of Memphis Announces Partnership with Donor Egg Bank USA 2Fertility Associates of Memphis Announces Partnership with Donor Egg Bank USA 3BioPlus Specialty Pharmacy Promotes Dr. Nick Maroulis to Vice President of Specialty Pharmacy Services 2Bina Technologies is acquired by Roche. 2Bina Technologies is acquired by Roche. 3
... following Webcast:, What: Transgenomic Inc. Fourth Quarter ... Conference Call, When: Thursday, February 28, 2008 ... How: Live over the Internet -- Simply log ... address above., To access the call via telephone, call ...
... 28 Memory,Pharmaceuticals Corp. (Nasdaq: MEMY ) announced today that it ... March,6, 2008, before the U.S. financial markets open. Management will provide a,Company ... 6, 2008, at 9:00 a.m. EST., Investors and ... ...
... New England Journal of Medicine, led by researchers at ... University of Massachusetts Medical School (UMMS), indicates a declining ... the first demonstration of a link between two independent ... has offered universal newborn screening to detect cystic fibrosis ...
Cached Biology Technology:Memory Pharmaceuticals to Announce Fourth Quarter and Full Year 2007 Results on Thursday, March 6, 2008 2Data show a decline in cystic fibrosis since introduction of prenatal carrier screening 2
(Date:12/19/2014)... 18, 2014   LaunchKey , the first decentralized ... and Internet of Things era, today announced the close ... round was led by Metamorphic Ventures with participation from ... VegasTechFund, and others.  LaunchKey has raised $4 million to ... its team and bring LaunchKey to market in 2015. ...
(Date:12/17/2014)... 2014 The Defense Logistics Agency is ... detect and prevent counterfeit microcircuits from entering into ... started performing an in-house microcircuit anti-counterfeit initiative dubbed ... of purchased microcircuits while increasing their reliability throughout ... will be conducted at DLA,s Electronics Product Test ...
(Date:12/17/2014)... 16, 2014 Valencell, a leader in performance ... technology to industry leaders such as Intel, Jabra, Atlas, ... biometric wearable products. These products will be showcased at ... Las Vegas . "Our partners ... and robust – with the clinical data to back ...
Breaking Biology News(10 mins):LaunchKey Raises $3 Million in Additional Funding Led by Metamorphic Ventures 2LaunchKey Raises $3 Million in Additional Funding Led by Metamorphic Ventures 3Defense Logistics Agency Launches DNA Marking Capability to Strengthen Microcircuit Supply Chain 2Defense Logistics Agency Launches DNA Marking Capability to Strengthen Microcircuit Supply Chain 3Valencell PerformTek Biometrics Power the Most Accurate Wearables at CES 2015 2
... an independent global commission of eminent scientists states that ... meet current and future threats to food security and ... Climate Change today released a Summary for Policy Makers ... of feeding the world in the face of climate ...
... Experts from Rusk Institute of Rehabilitation Medicine at ... clinical insight into complex medical rehabilitation, the treatment ... handheld technologies into practice management at the American ... Meeting in Orlando, November 17-20, 2011. Experts will ...
... is present in all vegetative matter that can be ... their own fuel. Last year, global biofuel production reached ... of the world,s transportation fuel. Bioethanol, a popular type ... such as corn and sugarcane. However, technologies are being ...
Cached Biology News:Global commission delivers food security policy recommendations 2Global commission delivers food security policy recommendations 3Rusk experts present at American Association of Physical Medicine and Rehabilitation meeting 2Toward more cost-effective production of biofuels from plant lignocellulosic biomass 2
... The lyophilization stabilizer is designed ... process and for long-term storage. ... toxic ingredients. It is a ... pH 7.2, and is superior to ...
... coating stabilizer is designed for stabilizing ... and antibodies for immunoassay development. ... during the coating and drying process ... It can also works as a ...
... Clinical is Tecans open platform for clinical ... safety and performance in the clinical diagnostic ... by flexible barcode reading and sample traceability ... the system complies with the IVD-Directive* established ...
... the smallest thermal cyclers on the market, which ... 0.5ml (20 samples) or 0.2ml microtube (25 samples) ... and cooling rate of 3.6C/sec and 2.0C/sec respectively ... Fast track programming with new quick dial facility ...
Biology Products: